Medac Exhibit 2087 Frontier Therapeutics v. Medac

Transcription

Ingredient
BETAMETHASONE VALERATE
CLINDAMYCIN PHOSPHATE
CLOBETASOL PROPIONATE
ECONAZOLE NITRATE
KETOCONAZOLE
TAZAROTENE
KETOCONAZOLE
MINOXIDIL
MINOXIDIL
CALCIPOTRIENE
DESONIDE
MINOXIDIL
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
FLUNISOLIDE
FLUNISOLIDE
ALBUTEROL
ALBUTEROL
ALBUTEROL
ALBUTEROL
METAPROTERENOL SULFATE
CICLESONIDE
CICLESONIDE
MOMETASONE FUROATE
MOMETASONE FUROATE
ATROPINE SULFATE
IPRATROPIUM BROMIDE
IPRATROPIUM BROMIDE
TRIAMCINOLONE ACETONIDE
BECLOMETHASONE DIPROPIONATE
TERBUTALINE SULFATE
TERBUTALINE SULFATE
SODIUM CHLORIDE
EPINEPHRINE BITARTRATE
EPINEPHRINE
ISOETHARINE MESYLATE
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
DEXAMETHASONE SODIUM PHOSPHATE
FORMOTEROL FUMARATE; MOMETASONE FUROATE
FORMOTEROL FUMARATE; MOMETASONE FUROATE
ISOPROTERENOL HYDROCHLORIDE; PHENYLEPHRINE BITARTRATE
EPINEPHRINE
FLUTICASONE PROPIONATE
CROMOLYN SODIUM
ISOPROTERENOL HYDROCHLORIDE
PIRBUTEROL ACETATE
PIRBUTEROL ACETATE
ERGOTAMINE TARTRATE
EPINEPHRINE BITARTRATE
ISOPROTERENOL SULFATE
EPINEPHRINE
ALBUTEROL SULFATE
ALBUTEROL
ALBUTEROL SULFATE
SALMETEROL XINAFOATE
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
NEDOCROMIL SODIUM
BITOLTEROL MESYLATE
ALBUTEROL
ALBUTEROL SULFATE
LEVALBUTEROL TARTRATE
TALC
BUDESONIDE
CICLESONIDE
HYDROCORTISONE ACETATE
NITROGLYCERIN
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
CHLORHEXIDINE GLUCONATE
LIDOCAINE
NITROGLYCERIN
DF;Route
AEROSOL, FOAM;TOPICAL
AEROSOL, METERED;INHALATION
AEROSOL, METERED;INTRAPLEURAL
AEROSOL, METERED;NASAL
AEROSOL, METERED;RECTAL
AEROSOL, METERED;SUBLINGUAL
AEROSOL, METERED;TOPICAL
AEROSOL;NASAL
AEROSOL;ORAL
AEROSOL;SUBLINGUAL
DEXAMETHASONE
HYDROCORTISONE
AEROSOL;TOPICAL
AEROSOL;TOPICAL
Medac Exhibit 2087
Frontier Therapeutics v. Medac
IPR2016-00649
Page 00001
Trade_Name
ECOZA
EVOCLIN
EXTINA
FABIOR
KETOCONAZOLE
LUXIQ
MEN'S ROGAINE
MINOXIDIL
OLUX
OLUX E
SORILUX
VERDESO
WOMEN'S ROGAINE
ADVAIR HFA
ADVAIR HFA
ADVAIR HFA
AEROBID
AEROSPAN HFA
ALBUTEROL
ALBUTEROL
ALBUTEROL
ALBUTEROL
ALUPENT
ALVESCO
ALVESCO
ASMANEX HFA
ASMANEX HFA
ATROPINE SULFATE
ATROVENT
ATROVENT HFA
AZMACORT
BECLOVENT
BRETHAIRE
BRICANYL
BRONCHO SALINE
BRONITIN MIST
BRONKAID MIST
BRONKOMETER
COMBIVENT
DEXACORT
DULERA
DULERA
DUO‐MEDIHALER
EPINEPHRINE
FLOVENT
FLOVENT
FLOVENT
FLOVENT HFA
FLOVENT HFA
FLOVENT HFA
INTAL
ISUPREL
MAXAIR
MAXAIR
MEDIHALER ERGOTAMINE
MEDIHALER‐EPI
MEDIHALER‐ISO
PRIMATENE MIST
PROAIR HFA
PROVENTIL
PROVENTIL‐HFA
QVAR 40
QVAR 80
SEREVENT
SYMBICORT
SYMBICORT
TILADE
TORNALATE
VANCERIL
VANCERIL DOUBLE STRENGTH
VENTOLIN
VENTOLIN HFA
XOPENEX HFA
SCLEROSOL
BECONASE
NASACORT
QNASL
RHINOCORT
VANCENASE
ZETONNA
CORTIFOAM
NITROMIST
EPIFOAM
EXIDINE
HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1%
PROCTOFOAM HC
DEXACORT
XYLOCAINE
NITROLINGUAL
Applicant
PERRIGO
PERRIGO UK FINCO
PERRIGO ISRAEL
PERRIGO ISRAEL
VELDANA MEDICAL SA
DELCOR ASSET
DELCOR ASSET CORP
STIEFEL LABS INC
PERRIGO ISRAEL
DELCOR ASSET
JOHNSON AND JOHNSON
PERRIGO ISRAEL
DELCOR ASSET
DELCOR ASSET
STIEFEL LABS INC
AQUA PHARMS
JOHNSON AND JOHNSON
GLAXO GRP LTD
GLAXO GRP LTD
GLAXO GRP LTD
ROCHE PALO
MEDA PHARMS INC
ARMSTRONG PHARMS
GENPHARM
IVAX SUB TEVA PHARMS
PLIVA
BOEHRINGER INGELHEIM
TAKEDA GMBH
TAKEDA GMBH
MERCK SHARP DOHME
MERCK SHARP DOHME
US ARMY
ABBVIE
GLAXOSMITHKLINE
NOVARTIS
SANOFI AVENTIS US
BLAIREX
WYETH CONS
STERLING
SANOFI AVENTIS US
UCB INC
MERCK SHARP DOHME
MERCK SHARP DOHME
3M
ARMSTRONG PHARMS
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXO GRP LTD
GLAXO GRP LTD
GLAXO GRP LTD
KING PFIZER
ALPHARMA US PHARMS
3M
ALPHARMA US PHARMS
SANOFI AVENTIS US
MEDICIS
VALEANT PHARM NORTH
3M
3M
3M
WYETH CONS
TEVA BRANDED PHARM
SCHERING
3M
TEVA BRANDED PHARM
TEVA BRANDED PHARM
GLAXOSMITHKLINE
ASTRAZENECA
ASTRAZENECA
KING PHARMS
SANOFI AVENTIS US
SCHERING
SCHERING
GLAXOSMITHKLINE
GLAXOSMITHKLINE
SUNOVION
BRYAN
GLAXOSMITHKLINE
SANOFI AVENTIS US
TEVA BRANDED PHARM
ASTRAZENECA
SCHERING
TAKEDA GMBH
MEDA PHARMS
MIST PHARMS LLC
MEDA PHARMS
XTTRIUM
VINTAGE PHARMS
MEDA PHARMS
UCB INC
ASTRAZENECA
POHL BOSKAMP
AEROSEB‐DEX
AEROSEB‐HC
ALLERGAN HERBERT
ALLERGAN HERBERT
Strength
0.12%
1%
0.05%
0.05%
1%
1%
2%
0.10%
2%
0.12%
5%
5%
0.05%
0.05%
0.01%
0.05%
5%
0.045MG/INH;EQ 0.021MG BASE/INH
0.25MG/INH
0.078MG/INH
0.09MG/INH
0.09MG/INH
0.09MG/INH
0.09MG/INH
0.65MG/INH
0.08MG/INH
0.16MG/INH
0.10MG/INH
0.20MG/INH
EQ 0.36MG BASE/INH
0.018MG/INH
0.021MG/INH
0.1MG/INH
0.042MG/INH
0.2MG/INH
0.2MG/INH
0.90%
0.3MG/INH
0.25MG/INH
0.34MG/INH
EQ 0.09MG BASE/INH;0.018MG/INH
EQ 0.1MG PHOSPHATE/INH
0.005MG/INH;0.1MG/INH
0.2MG/INH
0.044MG/INH
0.11MG/INH
0.22MG/INH
0.044MG/INH
0.11MG/INH
0.22MG/INH
0.8MG/INH
0.34MG/INH
0.12MG/INH
0.12MG/INH
0.103MG/INH
EQ 0.2MG BASE/INH
EQ 0.2MG BASE/INH
0.36MG/INH
0.3MG/INH
0.08MG/INH
0.2MG/INH
EQ 0.09MG BASE/INH
0.09MG/INH
EQ 0.09MG BASE/INH
0.04MG/INH
0.08MG/INH
EQ 0.021MG BASE/INH
1.75MG/INH
0.37MG/INH
0.042MG/INH
0.084MG/INH
0.09MG/INH
EQ 0.09MG BASE/INH
EQ 0.045MG BASE/INH
400MG/SPRAY
0.042MG/INH
0.055MG/INH
0.08MG/ACTUATION
0.032MG/INH
0.042MG/INH
0.037MG/INH
10%
0.4MG/SPRAY
1%;1%
4%
1%;1%
1%;1%
EQ 0.1MG PHOSPHATE/INH
10%
0.4MG/SPRAY
0.01% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
0.50%
Page 00002
Appl_Type
A
A
A
A
N
N
N
N
A
N
N
A
N
N
N
N
N
N
N
N
N
N
A
A
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
N
N
N
N
N
N
N
A
N
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
N
A
A
N
N
N
A
A
Appl_No Product_No TE_Code
78337
1 AB
90785
1 AT
77763
1 AB1
201402
1 AB2
205175
1
50801
1 AT
21738
1 AT
202428
1
91550
1 AT
20934
1 AB
21812
1
91344
1
21142
1 AB1
22013
1 AB2
22563
1
21978
1
21812
2
21254
1
21254
2
21254
3
18340
1
21247
1
72273
1
73045
1
73272
1
74072
1
16402
1
21658
2
21658
3
205641
1
205641
2
20056
1
19085
1
21527
1
18117
1
18153
1
18762
1
18000
1
19912
1
16126
2
16803
1
12339
7
20291
1
13413
1
22518
1
22518
2
13296
1
87907
1
20548
1
20548
2
20548
3
21433
3
21433
2
21433
1
18887
1
87858
1
10375
4
85904
1
11178
1
20014
1
19009
1
12102
1
10374
3
10375
3
16126
1
21457
1 BX
17559
1
20503
1 BX
20911
2
20911
1
20236
1
21929
1
21929
2
19660
1
18770
1
17573
1
20486
1
18473
1
20983
1 BX
21730
1
20587
1
18584
1
19798
1
202813
1
20233
1
18521
1
202129
1
17351
1
21780
1
86457
1 BX
19127
1
89440
1
86195
1 BX
14242
1
14394
1
18705
1
83296
85805
2
1
Approval_Date
26‐Nov‐12
31‐Mar‐10
10‐Mar‐08
14‐Aug‐12
24‐Oct‐13
22‐Oct‐04
12‐Jun‐07
11‐May‐12
25‐Aug‐11
28‐Feb‐99
20‐Jan‐06
28‐Apr‐11
26‐May‐00
12‐Jan‐07
6‐Oct‐10
19‐Sep‐06
28‐Feb‐14
8‐Jun‐06
8‐Jun‐06
8‐Jun‐06
17‐Aug‐84
27‐Jan‐06
14‐Aug‐96
19‐Aug‐97
28‐Dec‐95
1‐Aug‐96
Approved Prior to Jan 1, 1982
10‐Jan‐08
10‐Jan‐08
25‐Apr‐14
25‐Apr‐14
19‐Sep‐90
29‐Dec‐86
27‐Nov‐04
23‐Apr‐82
17‐Aug‐84
19‐Mar‐85
3‐Sep‐92
24‐Oct‐96
22‐Jun‐10
22‐Jun‐10
23‐May‐84
27‐Mar‐96
27‐Mar‐96
27‐Mar‐96
14‐May‐04
14‐May‐04
14‐May‐04
5‐Dec‐85
21‐Aug‐84
30‐Nov‐92
30‐Dec‐86
29‐Oct‐04
15‐Aug‐96
15‐Sep‐00
15‐Sep‐00
4‐Feb‐94
21‐Jul‐06
21‐Jul‐06
30‐Dec‐92
28‐Dec‐84
24‐Dec‐96
19‐Apr‐01
11‐Mar‐05
24‐Dec‐97
11‐Jul‐91
23‐Mar‐12
14‐Feb‐94
20‐Jan‐12
10‐Feb‐82
2‐Nov‐06
24‐Dec‐84
17‐May‐88
31‐Oct‐85
RLD
No
No
No
No
Yes
Yes
Yes
Yes
No
Yes
Yes
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
No
No
No
No
No
No
Yes
No
Yes
No
No
Yes
No
No
No
No
Yes
No
No
No
Yes
No
Yes
Yes
No
No
No
No
No
Yes
Yes
Yes
No
No
No
No
No
Yes
No
No
No
No
No
Yes
No
Yes
Yes
Yes
No
Yes
Yes
No
No
No
No
No
Yes
Yes
Yes
No
No
Yes
No
No
Yes
Yes
Yes
No
Yes
No
No
No
No
No
Type
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
OTC
OTC
RX
RX
RX
RX
OTC
RX
RX
RX
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
OTC
DISCN
DISCN
DISCN
RX
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
RX
RX
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
RX
DISCN
DISCN
RX
RX
RX
RX
OTC
DISCN
RX
DISCN
DISCN
DISCN
Applicant_Full_Name
PERRIGO CO
PERRIGO UK FINCO LTD PARTNERSHIP
PERRIGO ISRAEL PHARMACEUTICALS LTD
VELDANA MEDICAL SA
DELCOR ASSET CORP
DELCOR ASSET CORP
STIEFEL LABORATORIES INC
DELCOR ASSET CORP
JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES
DELCOR ASSET CORP
DELCOR ASSET CORP
AQUA PHARMACEUTICALS
JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES
GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
ROCHE PALO ALTO LLC
MEDA PHARMACEUTICALS INC
ARMSTRONG PHARMACEUTICALS INC
GENPHARM INC
IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
PLIVA INC
BOEHRINGER INGELHEIM PHARMACEUTICALS INC
TAKEDA GMBH
TAKEDA GMBH
MERCK SHARP AND DOHME CORP
UNITED STATES ARMY OFFICE SURGEON GENERAL
ABBVIE INC
GLAXOSMITHKLINE
NOVARTIS PHARMACEUTICALS CORP
SANOFI AVENTIS US LLC
BLAIREX LABORATORIES INC
WYETH CONSUMER HEALTHCARE
STERLING HEALTH DIV STERLING WINTHROP INC
UCB INC
3M PHARMACEUTICALS INC
ARMSTRONG PHARMACEUTICALS INC
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXO GROUP LTD DBA GLAXOSMITHKLINE
KING PHARMACEUTICALS INC SUB PFIZER INC
ALPHARMA US PHARMACEUTICALS DIVISION
MEDICIS PHARMACEUTICAL CORP
VALEANT PHARMACEUTICAL NORTH AMERICA LLC
WYETH CONSUMER HEALTHCARE
TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
SCHERING CORP SUB SCHERING PLOUGH CORP
GLAXOSMITHKLINE
ASTRAZENECA LP
ASTRAZENECA LP
KING PHARMACEUTICALS INC
SCHERING CORP
GLAXOSMITHKLINE
GLAXOSMITHKLINE INTELLECTUAL PROPERTY LTD ENGLAND
SUNOVION PHARMACEUTICALS INC
BRYAN CORP
GLAXOSMITHKLINE
ASTRAZENECA LP
TAKEDA GMBH
MIST PHARMACEUTICALS LLC
XTTRIUM LABORATORIES INC
VINTAGE PHARMACEUTICALS
UCB INC
ASTRAZENECA LP
POHL BOSKAMP
No
No
DISCN ALLERGAN HERBERT DIV ALLERGAN INC
DISCN ALLERGAN HERBERT DIV ALLERGAN INC
Page 00003
Ingredient
DF;Route
DEXAMETHASONE
BACITRACIN ZINC; POLYMYXIN B SULFATE
PIPERONYL BUTOXIDE; PYRETHRINS
HEXACHLOROPHENE
HEXACHLOROPHENE
NONOXYNOL‐9
CHOLESTYRAMINE
CHOLESTYRAMINE
AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
DOXYCYCLINE HYCLATE
AEROSOL;TOPICAL
AEROSOL;TOPICAL
AEROSOL;TOPICAL
AEROSOL;TOPICAL
AEROSOL;TOPICAL
AEROSOL;VAGINAL
BAR, CHEWABLE;ORAL
BAR, CHEWABLE;ORAL
CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL
CAPSULE, COATED PELLETS;ORAL
LANSOPRAZOLE; NAPROXEN
DULOXETINE HYDROCHLORIDE
DIVALPROEX SODIUM
DIDANOSINE
DIDANOSINE
DIDANOSINE
DIDANOSINE
DIDANOSINE
DIDANOSINE
DIDANOSINE
DIDANOSINE
DIDANOSINE
DIDANOSINE
DIDANOSINE
DIVALPROEX SODIUM
DIVALPROEX SODIUM
DIVALPROEX SODIUM
ERYTHROMYCIN
ERYTHROMYCIN
ERYTHROMYCIN
ERYTHROMYCIN
ERYTHROMYCIN
ERYTHROMYCIN
ERYTHROMYCIN
ERYTHROMYCIN
FLUOXETINE HYDROCHLORIDE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
CAPSULE, DELAYED REL PELLETS, TABLET;ORAL
CAPSULE, DELAYED REL PELLETS;ORAL
Page 00004
Trade_Name
Applicant
DECASPRAY
POLYSPORIN
RID MOUSSE
SEPTISOL
TURGEX
DELFEN
CHOLYBAR
CHOLYBAR
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN
PREVPAC
DOXYCYCLINE HYCLATE
MERCK
GLAXOSMITHKLINE
BAYER HEALTHCARE LLC
VESTAL LABS
XTTRIUM
PERSONAL PRODS
PARKE DAVIS
PARKE DAVIS
SANDOZ
TEVA PHARMS USA
TAKEDA PHARMS USA
PLIVA
PREVACID NAPRAPAC 250 (COPACKAGED)
CYMBALTA
CYMBALTA
CYMBALTA
DEPAKOTE
DIDANOSINE
DIDANOSINE
DIDANOSINE
DIDANOSINE
DIDANOSINE
DIDANOSINE
DIDANOSINE
DIDANOSINE
DIDANOSINE
DIDANOSINE
DIDANOSINE
DIVALPROEX SODIUM
DIVALPROEX SODIUM
DIVALPROEX SODIUM
ERYC
ERYC
ERYC
ERYC
ERYC 125
ERYC SPRINKLES
ERYTHROMYCIN
ERYTHROMYCIN
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
TAKEDA PHARMS NA
TAKEDA PHARMS NA
TAKEDA PHARMS NA
LILLY
LILLY
LILLY
ABBVIE
AUROBINDO PHARMA
AUROBINDO PHARMA
AUROBINDO PHARMA
AUROBINDO PHARMA
BARR
BARR
BARR
MYLAN PHARMS INC
MYLAN PHARMS INC
MYLAN PHARMS INC
MYLAN PHARMS INC
DR REDDYS LABS LTD
MYLAN
ZYDUS PHARMS USA INC
ACTAVIS ELIZABETH
ACTAVIS ELIZABETH
ACTAVIS ELIZABETH
ALEMBIC PHARMS LTD
ALEMBIC PHARMS LTD
ALEMBIC PHARMS LTD
APOTEX INC
APOTEX INC
APOTEX INC
AUROBINDO PHARMA LTD
BRECKENRIDGE PHARM
BRECKENRIDGE PHARM
BRECKENRIDGE PHARM
DR REDDYS LABS LTD
DR REDDYS LABS LTD
DR REDDYS LABS LTD
LUPIN LTD
LUPIN LTD
LUPIN LTD
LUPIN LTD
SUN PHARMA GLOBAL
SUN PHARMA GLOBAL
SUN PHARMA GLOBAL
TEVA PHARMS USA
TEVA PHARMS USA
TEVA PHARMS USA
TORRENT PHARMS LTD
TORRENT PHARMS LTD
TORRENT PHARMS LTD
MAYNE PHARMA
PARKE DAVIS
PARKE DAVIS
WARNER CHILCOTT LLC
PARKE DAVIS
HOSPIRA
ARBOR PHARMS LLC
BARR
BARR
DR REDDYS LABS LTD
DR REDDYS LABS LTD
DR REDDYS LABS LTD
DR REDDYS LABS LTD
MYLAN PHARMS INC
MYLAN PHARMS INC
NATCO PHARMA LTD
NATCO PHARMA LTD
PERRIGO R AND D
SANDOZ
SANDOZ
SUN PHARMA GLOBAL
SUN PHARMA GLOBAL
TEVA PHARMS
TEVA PHARMS
WOCKHARDT LTD
WOCKHARDT USA
WOCKHARDT USA
ZYDUS HLTHCARE
Strength
10,000 UNITS/GM;2,000,000 UNITS/GM
4%;EQ 0.33% BASE
0.23%
3%
12.50%
EQ 4GM RESIN/BAR
EQ 4GM RESIN/BAR
500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG
EQ 100MG BASE
15MG,N/A;N/A,250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
15MG,N/A;N/A,375MG
15MG,N/A;N/A,500MG
EQ 20MG BASE
EQ 30MG BASE
EQ 60MG BASE
EQ 125MG VALPROIC ACID
125MG
200MG
250MG
400MG
200MG
250MG
400MG
125MG
200MG
250MG
400MG
EQ 20MG BASE
EQ 30MG BASE
EQ 60MG BASE
EQ 20MG BASE
EQ 30MG BASE
EQ 60MG BASE
EQ 20MG BASE
EQ 30MG BASE
EQ 60MG BASE
EQ 20MG BASE
EQ 30MG BASE
EQ 60MG BASE
EQ 20MG BASE
EQ 30MG BASE
EQ 60MG BASE
EQ 20MG BASE
EQ 30MG BASE
EQ 60MG BASE
EQ 20MG BASE
EQ 30MG BASE
EQ 40MG BASE
EQ 60MG BASE
EQ 20MG BASE
EQ 30MG BASE
EQ 60MG BASE
EQ 20MG BASE
EQ 30MG BASE
EQ 60MG BASE
EQ 20MG BASE
EQ 30MG BASE
EQ 60MG BASE
EQ 20MG BASE
EQ 20MG BASE
EQ 30MG BASE
EQ 30MG BASE
EQ 60MG BASE
EQ 60MG BASE
250MG
250MG
250MG
250MG
125MG
125MG
250MG
250MG
EQ 90MG BASE
EQ 90MG BASE
15MG
15MG
30MG
15MG
30MG
15MG
30MG
15MG
15MG
30MG
15MG
30MG
15MG
30MG
15MG
15MG
30MG
15MG
Page 00005
Appl_Type
Approval_Date
RLD Type
Applicant_Full_Name
N
N
N
N
N
N
A
A
A
A
N
A
12731
50167
21043
17424
18375
14349
71621
71739
202588
200218
50757
63187
2
2
1
1
1
2
1
1
1 AB
1 AB
1 AB
1
1‐Mar‐85
7‐Mar‐00
26‐May‐88
26‐May‐88
4‐Mar‐14
30‐Aug‐13
2‐Dec‐97
30‐Jun‐92
No
No
Yes
No
No
No
No
No
No
No
Yes
No
DISCN
DISCN
OTC
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
MERCK AND CO INC
GLAXOSMITHKLINE
VESTAL LABORATORIES DIV CHEMED CORP
PERSONAL PRODUCTS CO
PARKE DAVIS DIV WARNER LAMBERT CO
SANDOZ INC
TEVA PHARMACEUTICALS USA
TAKEDA PHARMACEUTICALS USA INC
PLIVA INC
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
A
A
A
A
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
21507
21507
21507
21427
21427
21427
19680
90094
90094
90094
90094
77167
77167
77167
90788
90788
90788
90788
78979
90407
78919
90776
90776
90776
202949
202949
202949
202045
202045
202045
90778
90778
90778
203088
203088
203088
90723
90723
90723
90694
90694
90694
90694
90745
90745
90745
90783
90783
90783
90774
90774
90774
90728
90739
90728
90739
90728
90739
50536
62546
62618
62338
62648
50593
62746
63098
76237
78572
91269
202194
91269
90763
90763
201921
201921
202319
90331
90331
202637
91509
77255
77255
202727
202176
202176
202366
2
3
4
1
2
4
1
1
2
3
4
1
2
3
1
2
3
4
1
1
1
1
2
3
1
2
3
1
2
3
1
2
3
1
2
3
1
2
3
1
2
3
4
1
2
3
1
2
3
1
2
3
1
1
2
2
3
3
1
1
1
1
1
1
1
1
1
1
1
1
2
1
2
1
2
1
1
2
1
1
1
2
1
1
2
1
14‐Nov‐03
14‐Nov‐03
14‐Nov‐03
3‐Aug‐04
3‐Aug‐04
3‐Aug‐04
12‐Sep‐89
24‐Sep‐08
24‐Sep‐08
24‐Sep‐08
24‐Sep‐08
3‐Dec‐04
3‐Dec‐04
3‐Dec‐04
8‐Apr‐10
8‐Apr‐10
8‐Apr‐10
8‐Apr‐10
23‐Jan‐09
28‐Mar‐11
27‐Jan‐09
17‐Dec‐13
17‐Dec‐13
17‐Dec‐13
9‐Jun‐14
9‐Jun‐14
9‐Jun‐14
11‐Jun‐14
11‐Jun‐14
11‐Jun‐14
11‐Dec‐13
11‐Dec‐13
11‐Dec‐13
11‐Jun‐14
11‐Jun‐14
11‐Jun‐14
11‐Dec‐13
11‐Dec‐13
11‐Dec‐13
11‐Dec‐13
11‐Dec‐13
11‐Dec‐13
11‐Dec‐13
11‐Dec‐13
11‐Dec‐13
11‐Dec‐13
11‐Dec‐13
11‐Dec‐13
11‐Dec‐13
11‐Dec‐13
11‐Dec‐13
11‐Dec‐13
8‐Jan‐14
8‐Jan‐14
8‐Jan‐14
8‐Jan‐14
8‐Jan‐14
8‐Jan‐14
25‐Jul‐85
25‐Sep‐85
24‐Oct‐85
22‐Jul‐85
22‐Dec‐86
4‐May‐89
24‐Mar‐10
22‐Mar‐10
15‐Oct‐10
18‐May‐12
15‐Oct‐10
10‐Nov‐09
10‐Nov‐09
18‐Dec‐12
18‐Dec‐12
18‐May‐12
23‐Apr‐10
23‐Apr‐10
13‐Sep‐13
13‐Sep‐13
10‐Nov‐09
10‐Nov‐09
18‐May‐12
14‐Sep‐12
14‐Sep‐12
19‐Aug‐13
No
No
No
No
No
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
RX
RX
OTC
RX
RX
RX
RX
RX
OTC
RX
RX
RX
RX
RX
RX
OTC
RX
RX
RX
TAKEDA PHARMACEUTICALS NORTH AMERICA INC
ELI LILLY AND CO
ELI LILLY AND CO
ELI LILLY AND CO
ABBVIE INC
BARR LABORATORIES INC
MYLAN PHARMACEUTICALS INC
DR REDDYS LABORATORIES LTD
ZYDUS PHARMACEUTICALS USA INC
ACTAVIS ELIZABETH LLC
ALEMBIC PHARMACEUTICALS LTD
APOTEX INC
APOTEX INC
APOTEX INC
BRECKENRIDGE PHARMACEUTICAL INC
LUPIN LTD
LUPIN LTD
LUPIN LTD
LUPIN LTD
SUN PHARMA GLOBAL FZE
TORRENT PHARMACEUTICALS LTD
MAYNE PHARMA INTERNATIONAL PTY LTD
WARNER CHILCOTT CO LLC
HOSPIRA INC
ARBOR PHARMACEUTICALS LLC
NATCO PHARMA LTD
NATCO PHARMA LTD
PERRIGO R AND D CO
SANDOZ INC
SANDOZ INC
WOCKHARDT LTD
WOCKHARDT USA LLC
WOCKHARDT USA LLC
ZYDUS HEALTHCARE USA LLC
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
Page 00006
Ingredient
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
ESOMEPRAZOLE MAGNESIUM
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
LANSOPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
DIDANOSINE
DIDANOSINE
DIDANOSINE
DIDANOSINE
RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUM
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
MESALAMINE
DEXLANSOPRAZOLE
DEXLANSOPRAZOLE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
ESOMEPRAZOLE STRONTIUM
CHOLINE FENOFIBRATE
CHOLINE FENOFIBRATE
CHOLINE FENOFIBRATE
CHOLINE FENOFIBRATE
CHOLINE FENOFIBRATE
CHOLINE FENOFIBRATE
OMEPRAZOLE MAGNESIUM
CYSTEAMINE BITARTRATE
VALPROIC ACID
VALPROIC ACID
VALPROIC ACID
DIMETHYL FUMARATE
DIMETHYL FUMARATE
CHOLINE FENOFIBRATE
CHOLINE FENOFIBRATE
ACETAZOLAMIDE
ACETAZOLAMIDE
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
DF;Route
CAPSULE, DELAYED RELEASE;ORAL
CAPSULE, EXTENDED RELEASE;ORAL
Page 00007
Trade_Name
LANSOPRAZOLE
LANSOPRAZOLE LANSOPRAZOLE NEXIUM
NEXIUM
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
OMEPRAZOLE
PREVACID
PREVACID
PREVACID 24 HR
PRILOSEC
PRILOSEC
PRILOSEC
PROZAC WEEKLY
VIDEX EC
VIDEX EC
VIDEX EC
VIDEX EC
ACIPHEX SPRINKLE
ACIPHEX SPRINKLE
CREON
CREON
CREON
CREON
CREON
DELZICOL
DEXILANT
DEXILANT
DORYX
DORYX
DORYX
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
FENOFIBRIC ACID
FENOFIBRIC ACID
FENOFIBRIC ACID
FENOFIBRIC ACID
FENOFIBRIC ACID
FENOFIBRIC ACID
NEXIUM 24HR
PANCREAZE
PANCREAZE
PANCREAZE
PANCREAZE
PANCREAZE
PERTZYE
PERTZYE
PROCYSBI
PROCYSBI
STAVZOR
STAVZOR
STAVZOR
TECFIDERA
TECFIDERA
TRILIPIX
TRILIPIX
ULTRESA
ULTRESA
ULTRESA
ZENPEP
ZENPEP
ZENPEP
ZENPEP
ZENPEP
ZENPEP
ZENPEP
ACETAZOLAMIDE
ACETAZOLAMIDE
ACTIFED
Applicant
ZYDUS HLTHCARE
KRKA TOVARNA ZDRAVIL
KRKA TOVARNA ZDRAVIL
ASTRAZENECA
ASTRAZENECA
ACTAVIS LABS FL INC
ACTAVIS LABS FL INC
ACTAVIS LABS FL INC
APOTEX
APOTEX
APOTEX
DR REDDYS LABS LTD
DR REDDYS LABS LTD
DR REDDYS LABS LTD
DR REDDYS LABS LTD
DR REDDYS LABS LTD
DR REDDYS LABS LTD
IMPAX LABS
IMPAX LABS
IMPAX LABS
KREMERS URBAN PHARMS
MYLAN
MYLAN
MYLAN
SANDOZ
SANDOZ
SANDOZ
TAKEDA PHARMS USA
TAKEDA PHARMS USA
NOVARTIS
ASTRAZENECA
ASTRAZENECA
ASTRAZENECA
LILLY
BRISTOL MYERS SQUIBB
EISAI INC
EISAI INC
ABBVIE
ABBVIE
ABBVIE
ABBVIE
ABBVIE
WARNER CHILCOTT LLC
TAKEDA PHARMS USA
TAKEDA PHARMS USA
MAYNE PHARMA INTL
MAYNE PHARMA INTL
WARNER CHILCOTT
MEDICIS
MEDICIS
HANMI PHARM CO LTD
HANMI PHARM CO LTD
ANCHEN PHARMS
ANCHEN PHARMS
LUPIN LTD
LUPIN LTD
MYLAN PHARMS INC
MYLAN PHARMS INC
ASTRAZENECA LP
DR REDDYS LABS LTD
JANSSEN PHARMS
JANSSEN PHARMS
JANSSEN PHARMS
JANSSEN PHARMS
JANSSEN PHARMS
DIGESTIVE CARE INC
DIGESTIVE CARE INC
RAPTOR INC
RAPTOR INC
BANNER PHARMACAPS
BANNER PHARMACAPS
BANNER PHARMACAPS
BIOGEN IDEC INC
BIOGEN IDEC INC
ABBVIE
ABBVIE
FOREST LABS INC
FOREST LABS INC
FOREST LABS INC
FOREST LABS INC
FOREST LABS INC
FOREST LABS INC
FOREST LABS INC
FOREST LABS INC
FOREST LABS INC
FOREST LABS INC
HERITAGE PHARMS INC
GLAXOSMITHKLINE
Strength
30MG
15MG
30MG
EQ 20MG BASE
EQ 40MG BASE
10MG
20MG
40MG
10MG
20MG
40MG
10MG
10MG
20MG
20MG
40MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
10MG
20MG
40MG
15MG
30MG
15MG
10MG
20MG
40MG
EQ 90MG BASE
125MG
200MG
250MG
400MG
5MG
10MG
60,000USP UNITS;12,000USP UNITS;38,000USP UNITS
400MG
30MG
60MG
EQ 75MG BASE
EQ 100MG BASE
EQ 100MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 20MG BASE
EQ 40MG BASE
EQ 45MG FENOFIBRIC ACID
EQ 20MG BASE
EQ 20MG BASE
17,500USP/ UNITS;4,200USP/ UNITS;10,000USP/ UNITS
EQ 25MG BASE
EQ 75MG BASE
125MG
250MG
500MG
120MG
240MG
218,000USP UNITS; 40,00USP UNITS; 136,000 USP UNITS
500MG
500MG
120MG;5MG
ADDERALL XR 10
SHIRE
2.5MG;2.5MG;2.5MG;2.5MG
Page 00008
Appl_Type
A
A
A
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
N
N
A
A
A
A
A
A
N
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
N
N
202366
2 AB
91212
1 AB
91212
2 AB
21153
1
21153
2
75347
1 AB
75347
2 AB
75347
3 AB
76048
1 AB
76048
2 AB
76048
3 AB
75576
3 AB
78490
2 AB
75576
2 AB
78490
3 AB
75576
1 AB
78490
1 AB
75785
1 AB
75785
2 AB
75785
3 AB
75410
1 AB
75410
2 AB
75410
3 AB
75876
1 AB
75876
2 AB
75876
3 AB
75757
1 AB
75757
2 AB
76515
1 AB
91352
1 AB
91352
2 AB
91352
3 AB
20406
1 AB
20406
2 AB
22327
1
19810
3 AB
19810
1 AB
19810
2 AB
21235
1 AB
21183
1 AB
21183
2 AB
21183
3 AB
21183
4 AB
204736
1
204736
2
20725
2
20725
4
20725
1
20725
5
20725
3
204412
1
22287
1
22287
2
50582
2
50582
1
62653
1
65281
1
65281
2
202342
1
202342
2
201573
2 AB
201573
1 AB
200750
1 AB
200750
2 AB
200913
1 AB
200913
2 AB
204655
1
78878
1
22523
5
22523
1
22523
2
22523
3
22523
4
22175
1
22175
2
203389
1
203389
2
22152
1
22152
2
22152
3
204063
1
204063
2
22224
1 AB
22224
2 AB
22222
1
22222
2
22222
3
22210
7
22210
5
22210
2
22210
3
22210
1
22210
4
22210
6
90779
1 AB
40904
1 AB
18996
1
21303
1 AB
Approval_Date
19‐Aug‐13
16‐Sep‐13
16‐Sep‐13
20‐Feb‐01
20‐Feb‐01
30‐May‐08
30‐May‐08
30‐May‐08
22‐Oct‐07
22‐Oct‐07
21‐Jan‐09
22‐Oct‐07
16‐Mar‐09
22‐Oct‐07
16‐Mar‐09
21‐Jan‐09
17‐Apr‐09
22‐Oct‐07
22‐Oct‐07
21‐Jan‐09
1‐Nov‐02
1‐Nov‐02
23‐Jan‐09
29‐May‐03
29‐May‐03
21‐Jan‐09
28‐Jan‐03
28‐Jan‐03
21‐Jan‐09
19‐Nov‐12
19‐Nov‐12
19‐Nov‐12
10‐May‐95
10‐May‐95
18‐May‐09
5‐Oct‐95
14‐Sep‐89
15‐Jan‐98
26‐Feb‐01
31‐Oct‐00
31‐Oct‐00
31‐Oct‐00
31‐Oct‐00
26‐Mar‐13
26‐Mar‐13
30‐Apr‐09
12‐Jul‐11
30‐Apr‐09
14‐Mar‐13
30‐Apr‐09
1‐Feb‐13
30‐Jan‐09
30‐Jan‐09
13‐Aug‐01
22‐Jul‐85
30‐Oct‐85
21‐Dec‐05
21‐Dec‐05
6‐Aug‐13
6‐Aug‐13
18‐Jul‐13
18‐Jul‐13
4‐Dec‐13
4‐Dec‐13
25‐Mar‐13
25‐Mar‐13
28‐Mar‐14
5‐Jun‐09
7‐Mar‐14
12‐Apr‐10
12‐Apr‐10
12‐Apr‐10
12‐Apr‐10
17‐May‐12
17‐May‐12
30‐Apr‐13
30‐Apr‐13
29‐Jul‐08
29‐Jul‐08
29‐Jul‐08
27‐Mar‐13
27‐Mar‐13
15‐Dec‐08
15‐Dec‐08
1‐Mar‐12
1‐Mar‐12
1‐Mar‐12
25‐Mar‐14
15‐Jun‐11
27‐Aug‐09
27‐Aug‐09
27‐Aug‐09
27‐Aug‐09
13‐Jul‐11
14‐Jul‐11
10‐Dec‐08
17‐Jun‐85
RLD
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
Yes
Yes
Yes
No
No
No
Yes
No
Yes
No
No
No
No
Yes
Yes
No
Yes
No
No
No
No
Yes
No
Yes
No
No
No
No
No
No
Yes
Yes
No
No
No
Yes
No
No
Yes
No
Yes
No
No
No
No
Yes
No
Yes
No
No
Yes
No
No
No
No
No
No
Yes
No
No
No
11‐Oct‐01 No
Type
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
OTC
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
OTC
OTC
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
Applicant_Full_Name
ZYDUS HEALTHCARE USA LLC
KRKA TOVARNA ZDRAVIL DD NOVO MESTO
KRKA TOVARNA ZDRAVIL DD NOVO MESTO
ASTRAZENECA LP
ASTRAZENECA LP
ACTAVIS LABORATORIES FL INC
APOTEX INC
APOTEX INC
APOTEX INC
IMPAX LABORATORIES INC
KREMERS URBAN PHARMACEUTICALS INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
NOVARTIS CONSUMER HEALTH INC
ASTRAZENECA LP
ASTRAZENECA LP
ASTRAZENECA LP
ELI LILLY AND CO
BRISTOL MYERS SQUIBB CO
EISAI INC
EISAI INC
ABBVIE INC
ABBVIE INC
ABBVIE INC
ABBVIE INC
ABBVIE INC
WARNER CHILCOTT CO LLC
MAYNE PHARMA INTERNATIONAL FAULDING PHARM
MAYNE PHARMA INTERNATIONAL FAULDING PHARM
WARNER CHILCOTT BERMUDA LTD
HANMI PHARMACEUTICAL CO LTD
HANMI PHARMACEUTICAL CO LTD
ANCHEN PHARMACEUTICALS INC
LUPIN LTD
LUPIN LTD
ASTRAZENECA LP
JANSSEN PHARMACEUTICALS INC
DIGESTIVE CARE INC
DIGESTIVE CARE INC
RAPTOR PHARMACEUTICALS INC
RAPTOR PHARMACEUTICALS INC
BANNER PHARMACAPS INC
BIOGEN IDEC INC
BIOGEN IDEC INC
ABBVIE INC
ABBVIE INC
FOREST LABORATORIES INC
HERITAGE PHARMACEUTICALS INC
GLAXOSMITHKLINE
RX
SHIRE DEVELOPMENT INC
Page 00009
Ingredient
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
ASPIRIN; DIPYRIDAMOLE
CYCLOBENZAPRINE HYDROCHLORIDE
MESALAMINE
TRIHEXYPHENIDYL HYDROCHLORIDE
ASPIRIN; DIPYRIDAMOLE
TACROLIMUS
TACROLIMUS
TACROLIMUS
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX
PHENDIMETRAZINE TARTRATE
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
NICARDIPINE HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE
CHLORPHENIRAMINE MALEATE
CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
CHLORPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE
CHLORPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE
PROCHLORPERAZINE MALEATE
TRAMADOL HYDROCHLORIDE
CARVEDILOL PHOSPHATE
TOLTERODINE TARTRATE
DEXTROAMPHETAMINE SULFATE
DF;Route
Page 00010
Trade_Name
Applicant
Strength
ADDERALL XR 15
SHIRE
3.75MG;3.75MG;3.75MG;3.75MG
ADDERALL XR 20
SHIRE
5MG;5MG;5MG;5MG
ADDERALL XR 25
SHIRE
6.25MG;6.25MG;6.25MG;6.25MG
ADDERALL XR 30
SHIRE
7.5MG;7.5MG;7.5MG;7.5MG
ADDERALL XR 5
AEROLATE III
AEROLATE JR
AEROLATE SR
AGGRENOX
SHIRE
FLEMING PHARMS
FLEMING PHARMS
FLEMING PHARMS
1.25MG;1.25MG;1.25MG;1.25MG
65MG
130MG
260MG
25MG;200MG
AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF
TEVA
1.25MG;1.25MG;1.25MG;1.25MG
2.5MG;2.5MG;2.5MG;2.5MG
TEVA
TEVA
3.75MG;3.75MG;3.75MG;3.75MG
TEVA
5MG;5MG;5MG;5MG
TEVA
6.25MG;6.25MG;6.25MG;6.25MG
AMRIX
AMRIX
APRISO
ARTANE
ARTANE
ASPIRIN AND DIPYRIDAMOLE
ASTAGRAF XL
ASTAGRAF XL
ASTAGRAF XL
AVINZA
AVINZA
AVINZA
AVINZA
AVINZA
AVINZA
BIPHETAMINE 12.5
BIPHETAMINE 20
BIPHETAMINE 7.5
BONTRIL
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
CARBATROL
CARBATROL
CARBATROL
CARDENE SR
CARDENE SR
CARDENE SR
CARDIZEM CD
CARDIZEM CD
CARDIZEM CD
CARDIZEM CD
CARDIZEM CD
CARDIZEM SR
CARDIZEM SR
CARDIZEM SR
CARDIZEM SR
CARTIA XT
CARTIA XT
CARTIA XT
CARTIA XT
CODIMAL‐L.A. 12
COLD CAPSULE IV
COLD CAPSULE V
COMPAZINE
COMPAZINE
COMPAZINE
COMPAZINE
COMPAZINE
COMPAZINE
CONZIP
CONZIP
CONZIP
CONZIP
COREG CR
COREG CR
COREG CR
COREG CR
DETROL LA
DETROL LA
DEXEDRINE
DEXEDRINE
TEVA
IVAX INTL
IVAX INTL
SALIX PHARMS
LEDERLE
LEDERLE
BARR
ASTELLAS
ASTELLAS
ASTELLAS
KING PHARMS LLC
KING PHARMS LLC
KING PHARMS LLC
KING PHARMS LLC
KING PHARMS LLC
KING PHARMS LLC
UCB INC
UCB INC
UCB INC
VALEANT
APOTEX INC
APOTEX INC
APOTEX INC
NOSTRUM
NOSTRUM
NOSTRUM
TARO
TARO
TARO
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
SHIRE
SHIRE
SHIRE
CHIESI USA INC
CHIESI USA INC
CHIESI USA INC
VALEANT INTL
VALEANT INTL
VALEANT INTL
VALEANT INTL
VALEANT INTL
BIOVAIL
BIOVAIL
BIOVAIL
BIOVAIL
ACTAVIS LABS FL INC
ACTAVIS LABS FL INC
ACTAVIS LABS FL INC
ACTAVIS LABS FL INC
SANDOZ
SCHWARZ PHARMA
GRAHAM DM
GRAHAM DM
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
CIPHER PHARMS INC
CIPHER PHARMS INC
CIPHER PHARMS INC
CIPHER PHARMS INC
SB PHARMCO
SB PHARMCO
SB PHARMCO
SB PHARMCO
TWI PHARMS INC
TWI PHARMS INC
PHARMACIA AND UPJOHN
AMEDRA PHARMS
AMEDRA PHARMS
7.5MG;7.5MG;7.5MG;7.5MG
15MG
30MG
375MG
5MG
5MG
25MG;200MG
EQ 0.5MG BASE
EQ 1MG BASE
EQ 5MG BASE
30MG
45MG
60MG
75MG
90MG
120MG
EQ 6.25MG BASE;EQ 6.25MG BASE
EQ 10MG BASE;EQ 10MG BASE
105MG
100MG
200MG
300MG
100MG
200MG
300MG
100MG
200MG
300MG
100MG
200MG
300MG
100MG
200MG
300MG
30MG
45MG
60MG
120MG
180MG
240MG
300MG
360MG
60MG
90MG
120MG
180MG
120MG
180MG
240MG
300MG
12MG
12MG;120MG
12MG;75MG
8MG;75MG
EQ 10MG BASE
EQ 10MG BASE
EQ 15MG BASE
EQ 15MG BASE
EQ 30MG BASE
EQ 75MG BASE
100MG
150MG
200MG
300MG
10MG
20MG
40MG
80MG
15MG
30MG
2MG
4MG
5MG
10MG
Page 00011
Appl_Type
Approval_Date
RLD Type
Applicant_Full_Name
N
21303
6 AB
22‐May‐02 No
RX
N
21303
2 AB
11‐Oct‐01 No
RX
N
21303
4 AB
22‐May‐02 No
RX
N
21303
3 AB
N
A
A
A
N
21303
85075
85075
85075
20884
5 AB
3
2
1
1 AB
A
77488
1 AB
11‐Oct‐01 Yes RX
22‐May‐02
24‐Nov‐86
24‐Nov‐86
24‐Nov‐86
22‐Nov‐99
No
No
No
No
Yes
29‐Apr‐13 No
RX
DISCN
DISCN
DISCN
RX
FLEMING AND CO PHARMACEUTICALS INC
RX
TEVA PHARMACEUTICALS USA INC
A
77488
2 AB
29‐Apr‐13 No
RX
A
77488
3 AB
29‐Apr‐13 No
RX
A
77488
4 AB
29‐Apr‐13 No
RX
A
77488
A
N
N
N
N
N
A
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
N
N
N
N
77488
21777
21777
22301
6773
12947
78804
204096
204096
204096
21260
21260
21260
21260
21260
21260
10093
10093
10093
88021
78986
78986
78986
76697
76697
76697
201106
201106
201106
78592
78592
78592
20712
20712
20712
20005
20005
20005
20062
20062
20062
20062
20062
19471
19471
19471
19471
74752
74752
74752
74752
70797
18935
18793
18794
11000
21019
11000
21019
11000
11000
22370
22370
22370
22370
22012
22012
22012
22012
91281
91281
21228
21228
17078
17078
5 AB
6
1
2
1
10
1
1
1
2
3
1
5
2
6
3
4
7
3
9
1
1
2
3
1
2
3
1
2
3
1
2
3
3
1
2
1
2
3
1
2
3
4
5
1
2
3
4
2
1
3
4
1
1
1
1
1
1
2
2
3
4
1
4
2
3
1
2
3
4
1
2
1
2
1
2
AB
AB
AB
AB
AB2
AB2
AB2
AB2
AB2
AB2
BC
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB3
AB3
AB3
AB3
AB3
AB3
AB3
AB3
AB3
AB
AB
AB
AB
AB
AB
29‐Apr‐13 No
29‐Apr‐13
1‐Feb‐07
1‐Feb‐07
31‐Oct‐08
14‐Aug‐09
19‐Jul‐13
19‐Jul‐13
19‐Jul‐13
20‐Mar‐02
18‐Dec‐08
20‐Mar‐02
18‐Dec‐08
20‐Mar‐02
20‐Mar‐02
21‐Sep‐82
25‐Nov‐11
25‐Nov‐11
25‐Nov‐11
20‐May‐11
20‐May‐11
20‐May‐11
21‐Jun‐13
21‐Jun‐13
21‐Jun‐13
20‐Sep‐12
20‐Sep‐12
20‐Sep‐12
30‐Sep‐97
30‐Sep‐97
30‐Sep‐97
21‐Feb‐92
21‐Feb‐92
21‐Feb‐92
10‐Aug‐92
27‐Dec‐91
27‐Dec‐91
27‐Dec‐91
24‐Aug‐99
23‐Jan‐89
23‐Jan‐89
23‐Jan‐89
23‐Jan‐89
9‐Jul‐98
9‐Jul‐98
9‐Jul‐98
9‐Jul‐98
12‐Aug‐88
15‐Apr‐85
25‐Apr‐85
23‐Apr‐85
6‐Oct‐99
6‐Oct‐99
7‐May‐10
1‐Aug‐11
7‐May‐10
7‐May‐10
20‐Oct‐06
20‐Oct‐06
20‐Oct‐06
20‐Oct‐06
31‐Jan‐13
31‐Jan‐13
22‐Dec‐00
22‐Dec‐00
No
No
Yes
Yes
No
No
No
No
No
Yes
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
Yes
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
Yes
No
No
No
No
Yes
No
No
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
IVAX INTERNATIONAL GMBH
IVAX INTERNATIONAL GMBH
SALIX PHARMACEUTICALS INC
LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
ASTELLAS PHARMA US INC
KING PHARMACEUTICALS LLC
UCB INC
UCB INC
UCB INC
VALEANT PHARMACEUTICALS INTERNATIONAL
APOTEX INC
APOTEX INC
APOTEX INC
NOSTRUM PHARMACEUTICALS INC
TARO PHARMACEUTICAL INDUSTRIES LTD
CHIESI USA INC
CHIESI USA INC
CHIESI USA INC
VALEANT INTERNATIONAL BARBADOS SRL
BIOVAIL LABORATORIES INC
SANDOZ INC
SCHWARZ PHARMA INC
DM GRAHAM LABORATORIES INC
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
CIPHER PHARMACEUTICALS INC
SB PHARMCO PUERTO RICO INC
TWI PHARMACEUTICALS INC
TWI PHARMACEUTICALS INC
PHARMACIA AND UPJOHN CO
AMEDRA PHARMACEUTICALS LLC
Page 00012
Ingredient
DEXMETHYLPHENIDATE HYDROCHLORIDE
ACETAZOLAMIDE
ISOSORBIDE DINITRATE
DF;Route
Page 00013
Trade_Name
DEXEDRINE
Applicant
AMEDRA PHARMS
INTELLIPHARMACEUTICS
INTELLIPHARMACEUTICS
MYLAN PHARMS INC
TEVA PHARMS USA
TEVA PHARMS USA
TEVA PHARMS USA
TEVA PHARMS USA
TEVA PHARMS USA
TEVA PHARMS USA
WATSON LABS INC
WATSON LABS INC
Strength
15MG
15MG
30MG
30MG
5MG
10MG
15MG
20MG
30MG
40MG
15MG
30MG
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ACTAVIS ELIZABETH
1.25MG;1.25MG;1.25MG;1.25MG
ACTAVIS ELIZABETH
2.5MG;2.5MG;2.5MG;2.5MG
ACTAVIS ELIZABETH
3.75MG;3.75MG;3.75MG;3.75MG
ACTAVIS ELIZABETH
5MG;5MG;5MG;5MG
ACTAVIS ELIZABETH
6.25MG;6.25MG;6.25MG;6.25MG
ACTAVIS ELIZABETH
7.5MG;7.5MG;7.5MG;7.5MG
DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE
BARR LABS INC
1.25MG;1.25MG;1.25MG;1.25MG
BARR LABS INC
2.5MG;2.5MG;2.5MG;2.5MG
BARR LABS INC
3.75MG;3.75MG;3.75MG;3.75MG
BARR LABS INC
5MG;5MG;5MG;5MG
BARR LABS INC
6.25MG;6.25MG;6.25MG;6.25MG
DIAMOX
DILACOR XR
DILACOR XR
DILACOR XR
DILATRATE‐SR
DILT‐CD
DILT‐CD
DILT‐CD
DILT‐CD
BARR LABS INC
ABLE
ABLE
ABLE
ACTAVIS ELIZABETH
ACTAVIS ELIZABETH
ACTAVIS ELIZABETH
BARR
BARR
BARR
MALLINCKRODT
MALLINCKRODT
MALLINCKRODT
DURAMED PHARMS BARR
WATSON LABS
WATSON LABS
WATSON LABS
AUXILIUM PHARMS LLC
APOTEX
APOTEX
APOTEX
APOTEX
ACTAVIS ELIZABETH
ACTAVIS LABS FL INC
ACTAVIS LABS FL INC
ACTAVIS LABS FL INC
APOTEX
APOTEX
APOTEX
BIOVAIL
BIOVAIL
BIOVAIL
BIOVAIL
BIOVAIL
BIOVAIL
BIOVAIL
BIOVAIL
BIOVAIL
MYLAN
MYLAN
MYLAN
MYLAN
MYLAN
MYLAN
NESHER PHARMS
NESHER PHARMS
NESHER PHARMS
NESHER PHARMS
NESHER PHARMS
NESHER PHARMS
PAR PHARM
PAR PHARM
PAR PHARM
PAR PHARM
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SUN PHARMA GLOBAL
SUN PHARMA GLOBAL
SUN PHARMA GLOBAL
SUN PHARMA GLOBAL
SUN PHARMA GLOBAL
7.5MG;7.5MG;7.5MG;7.5MG
5MG
10MG
15MG
5MG
10MG
15MG
5MG
10MG
15MG
5MG
10MG
15MG
500MG
120MG
180MG
240MG
40MG
120MG
180MG
240MG
300MG
360MG
120MG
180MG
240MG
120MG
180MG
240MG
60MG
90MG
120MG
120MG
180MG
240MG
300MG
360MG
420MG
60MG
90MG
120MG
120MG
180MG
240MG
120MG
180MG
240MG
300MG
360MG
420MG
120MG
180MG
240MG
300MG
120MG
180MG
240MG
300MG
360MG
420MG
120MG
120MG
180MG
180MG
240MG
Page 00014
Appl_Type
N
A
A
A
A
A
A
A
A
A
A
A
17078
3 AB
78992
3 AB
78992
4 AB
202580
1 AB
78908
1 AB
78908
2 AB
78908
4 AB
78908
3 AB
202731
3 AB
202731
2 AB
79108
3 AB
79108
5 AB
Approval_Date
18‐Nov‐13
18‐Nov‐13
28‐Aug‐13
19‐Nov‐13
19‐Nov‐13
19‐May‐14
19‐Nov‐13
19‐May‐14
19‐Nov‐13
19‐May‐14
21‐Nov‐13
RLD
Yes
No
No
No
No
No
No
No
No
No
No
No
Type
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
Applicant_Full_Name
INTELLIPHARMACEUTICS CORP
INTELLIPHARMACEUTICS CORP
WATSON LABORATORIES INC
A
77302
1 AB
22‐Jun‐12 No
RX
A
77302
2 AB
22‐Jun‐12 No
RX
A
77302
3 AB
22‐Jun‐12 No
RX
A
77302
4 AB
22‐Jun‐12 No
RX
A
77302
5 AB
22‐Jun‐12 No
RX
A
77302
6 AB
22‐Jun‐12 No
RX
A
76536
1 AB
12‐Feb‐13 No
RX
A
76536
2 AB
12‐Feb‐13 No
RX
A
76536
3 AB
12‐Feb‐13 No
RX
A
76536
4 AB
12‐Feb‐13 No
RX
A
76536
5 AB
12‐Feb‐13 No
RX
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
76536
76814
76814
76814
203901
203901
203901
76137
76137
76137
76353
76353
76353
12945
20092
20092
20092
19790
76151
76151
76151
76151
202463
74852
74852
74852
74943
74943
74943
74845
74845
74845
20939
20939
20939
20939
20939
20939
74910
74910
74910
75124
75124
75124
76563
76563
76563
76563
76563
76563
74984
74984
74984
74984
91022
91022
91022
91022
91022
91022
90421
90492
90421
90492
90421
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
ABLE LABORATORIES INC
MALLINCKRODT INC
MALLINCKRODT INC
MALLINCKRODT INC
DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC
AUXILIUM PHARMACEUTICALS LLC
APOTEX INC
APOTEX INC
APOTEX INC
APOTEX INC
APOTEX INC
APOTEX INC
APOTEX INC
NESHER PHARMACEUTICALS USA LLC
PAR PHARMACEUTICAL INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
6
1
2
3
1
2
3
1
2
3
1
2
3
1
1
2
3
1
1
2
3
4
1
1
2
3
3
2
1
1
2
3
1
2
3
4
5
6
1
2
3
2
3
1
2
3
4
5
6
1
1
2
3
4
1
2
3
4
5
6
1
1
2
2
3
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB2
AB2
AB2
AB3
AB3
AB3
AB3
AB3
AB2
AB2
AB2
AB2
AB2
AB2
BC
AB2
AB2
AB2
AB3
AB3
AB3
AB3
AB4
AB4
AB4
AB4
AB4
AB4
AB4
AB3
AB4
AB3
AB4
12‐Feb‐13
25‐Aug‐04
25‐Aug‐04
25‐Aug‐04
30‐Nov‐12
30‐Nov‐12
30‐Nov‐12
18‐Jan‐02
18‐Jan‐02
18‐Jan‐02
6‐May‐03
6‐May‐03
6‐May‐03
29‐May‐92
29‐May‐92
29‐May‐92
2‐Sep‐88
20‐May‐04
20‐May‐04
20‐May‐04
20‐May‐04
7‐Dec‐12
10‐Oct‐97
10‐Oct‐97
10‐Oct‐97
19‐Dec‐00
19‐Dec‐00
6‐Aug‐98
15‐Sep‐99
15‐Sep‐99
15‐Sep‐99
28‐Jan‐00
28‐Jan‐00
28‐Jan‐00
28‐Jan‐00
14‐Sep‐01
14‐Sep‐01
2‐May‐97
2‐May‐97
2‐May‐97
18‐Mar‐98
18‐Mar‐98
18‐Mar‐98
12‐Sep‐06
12‐Sep‐06
12‐Sep‐06
12‐Sep‐06
12‐Sep‐06
12‐Sep‐06
20‐Dec‐99
20‐Dec‐99
20‐Dec‐99
20‐Dec‐99
28‐Sep‐12
28‐Sep‐12
28‐Sep‐12
28‐Sep‐12
28‐Sep‐12
28‐Sep‐12
15‐Nov‐10
28‐Oct‐11
15‐Nov‐10
28‐Oct‐11
15‐Nov‐10
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Page 00015
Ingredient
DISOPYRAMIDE PHOSPHATE
VENLAFAXINE HYDROCHLORIDE
THEOPHYLLINE
THEOPHYLLINE
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
CARBAMAZEPINE
CARBAMAZEPINE
CARBAMAZEPINE
LEVOMILNACIPRAN HYDROCHLORIDE
FLUVOXAMINE MALEATE
FLUVOXAMINE MALEATE
FLUVOXAMINE MALEATE
FLUVOXAMINE MALEATE
GALANTAMINE HYDROBROMIDE
DIPHENYLPYRALINE HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE
HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
PHENTERMINE RESIN COMPLEX
ISOSORBIDE DINITRATE
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
DF;Route
Page 00016
Trade_Name
DILTZAC
DILTZAC
DILTZAC
DILTZAC
DILTZAC
EFFEXOR XR
EFFEXOR XR
EFFEXOR XR
EFFEXOR XR
ELIXOPHYLLIN SR
ELIXOPHYLLIN SR
EMBEDA
EMBEDA
EMBEDA
EMBEDA
EMBEDA
EMBEDA
EQUETRO
EQUETRO
EQUETRO
FETZIMA
FETZIMA
FETZIMA
FETZIMA
FLUVOXAMINE MALEATE
FLUVOXAMINE MALEATE
FLUVOXAMINE MALEATE
FLUVOXAMINE MALEATE
FOCALIN XR
FOCALIN XR
FOCALIN XR
FOCALIN XR
FOCALIN XR
FOCALIN XR
FOCALIN XR
FOCALIN XR
HISPRIL
INDERAL LA
INDERAL LA
INDERAL LA
INDERAL LA
INDERIDE LA 120/50
INDERIDE LA 160/50
INDERIDE LA 80/50
INDOCIN SR
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INNOPRAN XL
INNOPRAN XL
IONAMIN
IONAMIN
ISOCLOR
ISORDIL
K‐LEASE
K‐LEASE
KADIAN
KADIAN
KADIAN
KADIAN
KADIAN
KADIAN
KADIAN
KADIAN
KADIAN
KADIAN
Applicant
SUN PHARMA GLOBAL
SUN PHARMA GLOBAL
SUN PHARMA GLOBAL
SUN PHARMA GLOBAL
SUN PHARMA GLOBAL
TEVA
TEVA
TEVA
VALEANT INTL
VALEANT INTL
VALEANT INTL
VALEANT INTL
APOTEX INC
APOTEX INC
APOTEX INC
APOTEX INC
APOTEX INC
NESHER PHARMS
WYETH PHARMS INC
WYETH PHARMS INC
WYETH PHARMS INC
WYETH PHARMS INC
FOREST LABS
FOREST LABS
ALPHARMA PHARMS
ALPHARMA PHARMS
ALPHARMA PHARMS
ALPHARMA PHARMS
ALPHARMA PHARMS
ALPHARMA PHARMS
VALIDUS PHARMS INC
VALIDUS PHARMS INC
VALIDUS PHARMS INC
FOREST LABS INC
FOREST LABS INC
FOREST LABS INC
FOREST LABS INC
ACTAVIS ELIZABETH
ACTAVIS ELIZABETH
ANCHEN PHARMS
ANCHEN PHARMS
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS
BARR
BARR
BARR
IMPAX LABS
IMPAX LABS
IMPAX LABS
MYLAN
MYLAN
MYLAN
SUN PHARMA GLOBAL
SUN PHARMA GLOBAL
SUN PHARMA GLOBAL
WATSON LABS
WATSON LABS
WATSON LABS
GLAXOSMITHKLINE
AKRIMAX PHARMS
AKRIMAX PHARMS
AKRIMAX PHARMS
AKRIMAX PHARMS
WYETH AYERST
WYETH AYERST
WYETH AYERST
IROKO PHARMS
ABLE
AMNEAL PHARMS
AVANTHI INC
HETERO LABS LTD III
INWOOD LABS
MYLAN PHARMS INC
PADDOCK LLC
SANDOZ
WATSON LABS INC
GLAXOSMITHKLINE LLC
GLAXOSMITHKLINE LLC
UCB INC
UCB INC
FISONS
WYETH AYERST
SAVAGE LABS
SAVAGE LABS
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
Strength
240MG
300MG
300MG
360MG
360MG
60MG
90MG
120MG
120MG
180MG
240MG
300MG
120MG
180MG
240MG
300MG
360MG
EQ 150MG BASE
EQ 37.5MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 150MG BASE
125MG
250MG
20MG;0.8MG
30MG;1.2MG
50MG;2MG
60MG;2.4MG
80MG;3.2MG
100MG;4MG
100MG
200MG
300MG
EQ 20MG BASE
EQ 40MG BASE
EQ 80MG BASE
EQ 120MG BASE
100MG
150MG
100MG
150MG
5MG
10MG
15MG
20MG
25MG
30MG
35MG
40MG
EQ 8MG BASE
EQ 16MG BASE
EQ 24MG BASE
EQ 8MG BASE
EQ 16MG BASE
EQ 24MG BASE
EQ 8MG BASE
EQ 16MG BASE
EQ 24MG BASE
EQ 8MG BASE
EQ 16MG BASE
EQ 24MG BASE
EQ 8MG BASE
EQ 16MG BASE
EQ 24MG BASE
5MG
60MG
80MG
120MG
160MG
50MG;120MG
50MG;160MG
50MG;80MG
75MG
75MG
75MG
75MG
75MG
75MG
75MG
75MG
75MG
75MG
80MG
120MG
EQ 15MG BASE
EQ 30MG BASE
8MG;120MG
40MG
8MEQ
10MEQ
10MG
20MG
30MG
40MG
50MG
60MG
70MG
80MG
100MG
130MG
Page 00017
Appl_Type
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
A
N
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
A
A
N
N
N
N
N
N
N
N
N
N
90492
3 AB3
90421
4 AB4
90492
4 AB3
90421
5 AB4
90492
5 AB3
74079
1
74079
2
74079
3
75116
1 AB3
75116
2 AB3
75116
3 AB3
75116
4 AB3
76395
1 AB4
76395
2 AB4
76395
3 AB4
76395
4 AB4
76395
5 AB4
71200
1
20699
1 AB
20699
2 AB
20699
3
20699
4 AB
86826
1
86826
2
22321
1
22321
2
22321
3
22321
4
22321
5
22321
6
21710
1
21710
2
21710
3
204168
1
204168
2
204168
3
204168
4
91482
1 AB
91482
2 AB
91476
1 AB
91476
2 AB
21802
1 AB
21802
2 AB
21802
4 AB
21802
3 AB
21802
8
21802
5 AB
21802
7
21802
6 AB
78189
1 AB
78189
2 AB
78189
3 AB
78484
1 AB
78484
2 AB
78484
3 AB
90900
1 AB
90900
2 AB
90900
3 AB
90178
1 AB
90178
2 AB
90178
3 AB
79028
1 AB
79028
2 AB
79028
3 AB
11945
1
18553
4 AB
18553
2 AB
18553
3 AB
18553
1 AB
19059
2
19059
3
19059
1
18185
1
76114
1
91549
1 AB
79175
1 AB
201807
1 AB
72410
1
202139
1 AB
200529
1 AB
74464
1 AB
202572
1 AB
21438
1 BX
21438
2 BX
11613
4
11613
2
18747
1
12882
2
73398
1
72427
1
20616
8 AB1
20616
1 AB1
20616
4 AB1
20616
9
20616
2 AB1
20616
5 AB1
20616
10
20616
6 AB1
20616
3 AB1
20616
11
Approval_Date
28‐Oct‐11
15‐Nov‐10
28‐Oct‐11
15‐Nov‐10
28‐Oct‐11
30‐Nov‐93
30‐Nov‐93
30‐Nov‐93
23‐Dec‐99
23‐Dec‐99
23‐Dec‐99
23‐Dec‐99
1‐Feb‐06
1‐Feb‐06
1‐Feb‐06
1‐Feb‐06
1‐Feb‐06
15‐Dec‐87
20‐Oct‐97
20‐Oct‐97
20‐Oct‐97
20‐Oct‐97
29‐Jan‐85
29‐Jan‐85
13‐Aug‐09
13‐Aug‐09
13‐Aug‐09
13‐Aug‐09
13‐Aug‐09
13‐Aug‐09
10‐Dec‐04
10‐Dec‐04
10‐Dec‐04
25‐Jul‐13
25‐Jul‐13
25‐Jul‐13
25‐Jul‐13
23‐Apr‐13
18‐Nov‐13
13‐Mar‐13
13‐Mar‐13
26‐May‐05
26‐May‐05
1‐Aug‐06
26‐May‐05
21‐Apr‐11
23‐Oct‐09
21‐Apr‐11
11‐Aug‐10
15‐Sep‐08
15‐Sep‐08
15‐Sep‐08
27‐May‐09
27‐May‐09
27‐May‐09
24‐Jan‐11
24‐Jan‐11
24‐Jan‐11
2‐Feb‐11
2‐Feb‐11
2‐Feb‐11
15‐Dec‐08
15‐Dec‐08
15‐Dec‐08
18‐Mar‐87
19‐Apr‐83
19‐Apr‐83
19‐Apr‐83
3‐Jul‐85
3‐Jul‐85
3‐Jul‐85
23‐Feb‐82
6‐Feb‐02
1‐Dec‐10
6‐Mar‐09
28‐Sep‐12
15‐Mar‐89
20‐Mar‐14
30‐Nov‐10
28‐May‐98
9‐Dec‐13
12‐Mar‐03
12‐Mar‐03
6‐Mar‐86
29‐Jul‐88
28‐Jan‐92
28‐Mar‐90
20‐Apr‐07
3‐Jul‐96
9‐Mar‐01
9‐Jul‐12
3‐Jul‐96
9‐Mar‐01
9‐Jul‐12
27‐Oct‐06
3‐Jul‐96
9‐Jul‐12
RLD
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
Yes
No
No
No
No
Yes
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
Yes
No
Type
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
DISCN
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
Applicant_Full_Name
APOTEX INC ETOBICOKE SITE
WYETH PHARMACEUTICALS INC
ALPHARMA PHARMACEUTICALS LLC
VALIDUS PHARMACEUTICALS INC
GLAXOSMITHKLINE
AKRIMAX PHARMACEUTICALS LLC
WYETH AYERST LABORATORIES
IROKO PHARMACEUTICALS LLC
AMNEAL PHARMACEUTICALS
AVANTHI INC
HETERO LABS LTD UNIT III
INWOOD LABORATORIES INC SUB FOREST LABORATORIES INC
PADDOCK LABORATORIES LLC
SANDOZ INC
GLAXOSMITHKLINE LLC
GLAXOSMITHKLINE LLC
UCB INC
UCB INC
FISONS CORP
SAVAGE LABORATORIES INC DIV ALTANA INC
Page 00018
Ingredient
MORPHINE SULFATE
MORPHINE SULFATE
KETOPROFEN
KETOPROFEN
KETOPROFEN
KETOPROFEN
KETOPROFEN
KETOPROFEN
KETOPROFEN
CHLORDIAZEPOXIDE
FLUVOXAMINE MALEATE
FLUVOXAMINE MALEATE
MEPROBAMATE
MEPROBAMATE
METHYLPHENIDATE HYDROCHLORIDE
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MEMANTINE HYDROCHLORIDE
PSEUDOEPHEDRINE HYDROCHLORIDE
KETOPROFEN
KETOPROFEN
KETOPROFEN
HYDROMORPHONE HYDROCHLORIDE
MESALAMINE
MESALAMINE
PINACIDIL
PINACIDIL
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE
PROPAFENONE HYDROCHLORIDE
DF;Route
Page 00019
Trade_Name
KADIAN
KADIAN
KETOPROFEN
KETOPROFEN
KETOPROFEN
KETOPROFEN
KETOPROFEN
KETOPROFEN
KETOPROFEN
LIBRELEASE
LUVOX CR
LUVOX CR
MELFIAT‐105
MEPROSPAN
MEPROSPAN
METADATE CD
METADATE CD
METADATE CD
METADATE CD
METADATE CD
METADATE CD
MICRO‐K
MICRO‐K 10
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
NAMENDA XR
NAMENDA XR
NAMENDA XR
NAMENDA XR
NORPACE CR
NORPACE CR
NOVAFED
ORUVAIL
ORUVAIL
ORUVAIL
PALLADONE
PALLADONE
PALLADONE
PALLADONE
PENTASA
PENTASA
PHENTERMINE RESIN 30
PINDAC
PINDAC
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE
Applicant
WATSON LABS INC
WATSON LABS INC
ACTAVIS LABS FL INC
ACTAVIS LABS FL INC
ACTAVIS LABS FL INC
ALKERMES GAINESVILLE
MYLAN
MYLAN
MYLAN
VALEANT PHARM INTL
JAZZ PHARMS
JAZZ PHARMS
NUMARK
MEDPOINTE PHARM HLC
MEDPOINTE PHARM HLC
UCB INC
UCB INC
UCB INC
UCB INC
UCB INC
UCB INC
BARR LABS INC
BARR LABS INC
BARR LABS INC
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
NESHER PHARMS
NESHER PHARMS
ACTAVIS ELIZABETH
ACTAVIS ELIZABETH
ACTAVIS ELIZABETH
ACTAVIS ELIZABETH
ACTAVIS ELIZABETH
ACTAVIS ELIZABETH
PAR PHARM INC
PAR PHARM INC
PAR PHARM INC
PAR PHARM INC
PAR PHARM INC
PAR PHARM INC
UPSHER SMITH
UPSHER SMITH
UPSHER SMITH
UPSHER SMITH
UPSHER SMITH
UPSHER SMITH
UPSHER SMITH
FOREST LABS
FOREST LABS
FOREST LABS
FOREST LABS
GD SEARLE LLC
GD SEARLE LLC
SANOFI AVENTIS US
WYETH PHARMS INC
WYETH PHARMS INC
WYETH PHARMS INC
PURDUE PHARMA LP
PURDUE PHARMA LP
PURDUE PHARMA LP
PURDUE PHARMA LP
SHIRE
SHIRE
GRAHAM DM
GRAHAM DM
GRAHAM DM
GRAHAM DM
GRAHAM DM
GRAHAM DM
SANDOZ
SANDOZ
QUANTUM PHARMICS
LANNETT HOLDINGS INC
LEO PHARM
LEO PHARM
ACTAVIS LABS FL INC
ACTAVIS LABS FL INC
AMNEAL PHARMS
ANCHEN PHARMS
ANCHEN PHARMS
NESHER PHARMS
PADDOCK LLC
PADDOCK LLC
TEVA
TEVA
PAR PHARM
PAR PHARM
PAR PHARM
ACTAVIS ELIZABETH
ACTAVIS ELIZABETH
ACTAVIS ELIZABETH
ACTAVIS ELIZABETH
Strength
150MG
200MG
100MG
150MG
200MG
200MG
100MG
150MG
200MG
30MG
100MG
150MG
105MG
200MG
400MG
10MG
20MG
30MG
40MG
50MG
60MG
20MG
30MG
40MG
10MG
20MG
30MG
40MG
50MG
60MG
20MG
30MG
40MG
8MEQ
10MEQ
30MG
45MG
60MG
75MG
90MG
120MG
20MG
30MG
50MG
60MG
80MG
100MG
10MG
20MG
30MG
50MG
60MG
80MG
100MG
7MG
14MG
21MG
28MG
EQ 100MG BASE
EQ 150MG BASE
120MG
100MG
150MG
200MG
12MG
16MG
24MG
32MG
250MG
500MG
105MG
105MG
105MG
105MG
105MG
105MG
105MG
105MG
EQ 30MG BASE
EQ 15MG BASE
EQ 30MG BASE
12.5MG
25MG
8MEQ
10MEQ
10MEQ
8MEQ
10MEQ
10MEQ
8MEQ
10MEQ
8MEQ
10MEQ
225MG
325MG
425MG
60MG
80MG
120MG
160MG
Page 00020
Appl_Type
N
N
A
A
A
A
A
A
A
N
N
N
A
N
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
A
A
A
A
N
A
A
A
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
20616
12
20616
7 AB1
75270
2 AB
75270
3 AB
75270
1 AB
74879
1
75679
3 AB
75679
2 AB
75679
1 AB
17813
1
22033
1 AB
22033
2 AB
87487
1
11284
1
11284
2
21259
3 AB2
21259
1 AB2
21259
2 AB2
21259
4 AB2
21259
5 AB2
21259
6 AB2
79031
1 AB1
79031
2 AB1
79031
3 AB1
77707
1 AB2
77707
2 AB2
77707
3 AB2
78873
1 AB2
78873
2 AB2
78873
3 AB2
78458
1 AB1
78458
2 AB1
78458
3 AB1
18238
1 AB
18238
2 AB
79040
1 AB2
79040
2 AB2
79040
3 AB2
79040
4 AB2
79040
5 AB2
79040
6 AB2
200812
1 AB1
200812
2 AB1
200812
3 AB1
200812
4 AB1
200812
5 AB1
200812
6 AB1
202104
1 AB1
202104
2 AB1
202104
3 AB1
202104
4 AB1
202104
5 AB1
202104
6 AB1
202104
7 AB1
22525
1
22525
2
22525
3
22525
4
18655
1
18655
2 AB
17603
1
19816
3
19816
2
19816
1
21044
1
21044
2
21044
3
21044
4
20049
1
20049
2
87214
1
88020
1
88028
1
88062
1
88063
1
88111
1
87378
1
18074
1 BC
89120
1
40872
1
40872
2
19456
1
19456
2
77419
1 AB
77419
2 AB
202128
1 AB
202886
1 AB
202886
2 AB
70980
1
200185
1 AB
200185
2 AB
73531
1
73532
1
78540
1 AB
78540
2 AB
78540
3 AB
78494
1 AB
78494
2 AB
78494
3 AB
78494
4 AB
Approval_Date
9‐Jul‐12
27‐Feb‐07
24‐Mar‐99
24‐Mar‐99
24‐Mar‐99
10‐Dec‐97
20‐Feb‐02
20‐Feb‐02
20‐Feb‐02
12‐Sep‐83
28‐Feb‐08
28‐Feb‐08
13‐Oct‐82
27‐May‐03
3‐Apr‐01
19‐Jun‐03
19‐Feb‐06
19‐Feb‐06
19‐Feb‐06
13‐Jul‐12
13‐Jul‐12
13‐Jul‐12
19‐Jul‐12
19‐Jul‐12
19‐Jul‐12
19‐Jul‐12
19‐Jul‐12
19‐Jul‐12
1‐Dec‐11
1‐Dec‐11
1‐Dec‐11
14‐May‐84
16‐Jan‐13
16‐Jan‐13
16‐Jan‐13
16‐Jan‐13
16‐Jan‐13
16‐Jan‐13
10‐Nov‐11
10‐Nov‐11
10‐Nov‐11
10‐Nov‐11
10‐Nov‐11
10‐Nov‐11
3‐Jun‐13
3‐Jun‐13
3‐Jun‐13
3‐Jun‐13
3‐Jun‐13
3‐Jun‐13
3‐Jun‐13
21‐Jun‐10
21‐Jun‐10
21‐Jun‐10
21‐Jun‐10
20‐Jul‐82
20‐Jul‐82
8‐Feb‐95
8‐Feb‐95
24‐Sep‐93
24‐Sep‐04
24‐Sep‐04
24‐Sep‐04
24‐Sep‐04
10‐May‐93
8‐Jul‐04
26‐May‐82
16‐Aug‐82
16‐Aug‐82
13‐Sep‐82
10‐Sep‐82
18‐Oct‐82
4‐Feb‐88
28‐Jul‐11
28‐Jul‐11
28‐Dec‐89
28‐Dec‐89
2‐Jun‐08
2‐Jun‐08
22‐Feb‐13
26‐Dec‐13
26‐Dec‐13
17‐Feb‐87
18‐May‐11
18‐May‐11
26‐Apr‐96
26‐Apr‐96
18‐Oct‐10
18‐Oct‐10
18‐Oct‐10
10‐Aug‐07
10‐Aug‐07
10‐Aug‐07
10‐Aug‐07
RLD
No
Yes
No
No
No
No
No
No
Yes
No
No
Yes
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
Yes
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
Yes
No
Yes
Yes
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Type
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
DISCN
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
Applicant_Full_Name
ALKERMES GAINESVILLE LLC
JAZZ PHARMACEUTICALS INC
JAZZ PHARMACEUTICALS INC
NUMARK LABORATORIES INC
MEDPOINTE PHARMACEUTICALS MEDPOINTE HEALTHCARE INC
UCB INC
UCB INC
UCB INC
UCB INC
UCB INC
UCB INC
UPSHER SMITH LABORATORIES INC
GD SEARLE LLC
GD SEARLE LLC
PURDUE PHARMA LP
PURDUE PHARMA LP
PURDUE PHARMA LP
PURDUE PHARMA LP
SANDOZ INC
SANDOZ INC
QUANTUM PHARMICS LTD
LEO PHARMACEUTICAL PRODUCTS LTD
LEO PHARMACEUTICAL PRODUCTS LTD
PAR PHARMACEUTICAL
PAR PHARMACEUTICAL
PAR PHARMACEUTICAL
Page 00021
Ingredient
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TROSPIUM CHLORIDE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
DF;Route
PSEUDOEPHEDRINE HYDROCHLORIDE
TRIMEPRAZINE TARTRATE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
Page 00022
Trade_Name
PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
QSYMIA
QSYMIA
QSYMIA
QSYMIA
QUDEXY XR
QUDEXY XR
QUDEXY XR
QUDEXY XR
QUDEXY XR
RAZADYNE ER
RAZADYNE ER
RAZADYNE ER
RITALIN LA
RITALIN LA
RITALIN LA
RITALIN LA
RYTHMOL SR
RYTHMOL SR
RYTHMOL SR
SANCTURA XR
SLO‐BID
SLO‐BID
SLO‐BID
SLO‐BID
SLO‐BID
SLO‐BID
SLO‐PHYLLIN
SLO‐PHYLLIN
SLO‐PHYLLIN
SOMOPHYLLIN‐CRT
SOMOPHYLLIN‐CRT
SOMOPHYLLIN‐CRT
SOMOPHYLLIN‐CRT
SOMOPHYLLIN‐CRT
SPRX‐105
Applicant
APTALIS PHARMATECH
APTALIS PHARMATECH
APTALIS PHARMATECH
APTALIS PHARMATECH
INWOOD LABS
INWOOD LABS
INWOOD LABS
INWOOD LABS
MYLAN
MYLAN
MYLAN
MYLAN
NORTEC DEV ASSOC
NORTEC DEV ASSOC
NORTEC DEV ASSOC
NORTEC DEV ASSOC
UPSHER SMITH
UPSHER SMITH
UPSHER SMITH
UPSHER SMITH
CENT PHARMS
GRAHAM DM
GRAHAM DM
KV PHARM
VIVUS
VIVUS
VIVUS
VIVUS
UPSHER SMITH
UPSHER SMITH
UPSHER SMITH
UPSHER SMITH
UPSHER SMITH
JANSSEN PHARMS
JANSSEN PHARMS
JANSSEN PHARMS
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS
GLAXOSMITHKLINE LLC
GLAXOSMITHKLINE LLC
GLAXOSMITHKLINE LLC
ALLERGAN
SANOFI AVENTIS US
SANOFI AVENTIS US
SANOFI AVENTIS US
SANOFI AVENTIS US
SANOFI AVENTIS US
SANOFI AVENTIS US
SANOFI AVENTIS US
SANOFI AVENTIS US
SANOFI AVENTIS US
GRAHAM DM
GRAHAM DM
GRAHAM DM
GRAHAM DM
GRAHAM DM
NUMARK
SUDAFED 12 HOUR
TAZTIA XT
TAZTIA XT
TAZTIA XT
TAZTIA XT
TAZTIA XT
TELDRIN
TELDRIN
TEMARIL
THEO‐24
THEO‐24
THEO‐24
THEO‐24
THEO‐DUR
THEO‐DUR
THEO‐DUR
THEO‐DUR
THEOBID
THEOBID JR.
THEOCLEAR L.A.‐130
THEOCLEAR L.A.‐260
THEOPHYL‐SR
THEOPHYL‐SR
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE‐SR
THEOVENT
THEOVENT
GLAXOSMITHKLINE
ACTAVIS LABS FL INC
ACTAVIS LABS FL INC
ACTAVIS LABS FL INC
ACTAVIS LABS FL INC
ACTAVIS LABS FL INC
GLAXOSMITHKLINE
GLAXOSMITHKLINE
ALLERGAN HERBERT
ACTIENT PHARMS
ACTIENT PHARMS
ACTIENT PHARMS
ACTIENT PHARMS
SCHERING
SCHERING
SCHERING
SCHERING
WHITBY
WHITBY
SCHWARZ PHARMA
SCHWARZ PHARMA
ORTHO MCNEIL PHARM
ORTHO MCNEIL PHARM
CENT PHARMS
CENT PHARMS
HOSPIRA
HOSPIRA
HOSPIRA
INWOOD LABS
INWOOD LABS
INWOOD LABS
INWOOD LABS
SANDOZ
SCHERER RP
SCHERING
SCHERING
Strength
60MG
80MG
120MG
160MG
60MG
80MG
120MG
160MG
60MG
80MG
120MG
160MG
60MG
80MG
120MG
160MG
60MG
80MG
120MG
160MG
60MG
80MG
120MG
160MG
8MG;120MG
8MG;120MG
12MG;120MG
12MG;120MG
EQ 3.75MG BASE;23MG
EQ 7.5MG BASE;46MG
EQ 11.25MG BASE;69MG
EQ 15MG BASE;92MG
25MG
50MG
100MG
150MG
200MG
EQ 8MG BASE
EQ 16MG BASE
EQ 24MG BASE
10MG
20MG
30MG
40MG
225MG
325MG
425MG
60MG
50MG
75MG
100MG
125MG
200MG
300MG
60MG
125MG
250MG
50MG
100MG
200MG
250MG
300MG
105MG
120MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
120MG
180MG
240MG
300MG
360MG
8MG
12MG
EQ 5MG BASE
100MG
200MG
300MG
400MG
50MG
75MG
125MG
200MG
260MG
130MG
130MG
260MG
125MG
250MG
125MG
250MG
100MG
200MG
300MG
100MG
125MG
200MG
300MG
260MG
300MG
125MG
250MG
Page 00023
Appl_Type
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
A
A
A
A
A
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
78703
1 AB
78703
2 AB
78703
3 AB
78703
4 AB
72499
1
72500
1
72501
1
72502
1
78022
1 AB
78022
2 AB
78022
3 AB
78022
4 AB
78065
1 AB
78065
2 AB
78065
3 AB
78065
4 AB
78311
1 AB
78311
2 AB
78311
3 AB
78311
4 AB
90321
1 AB
90321
2 AB
90321
3 AB
90321
4 AB
19428
1
18844
1
18843
1
71455
1
22580
1
22580
2
22580
3
22580
4
205122
1
205122
2
205122
3
205122
4
205122
5
21615
1 AB
21615
2 AB
21615
3 AB
21284
4 BX
21284
1 AB1
21284
2 AB1
21284
3 AB1
21416
1 AB
21416
2 AB
21416
3 AB
22103
1 AB
88269
1
89539
1
87892
1
89540
1
87893
1
87894
1
85206
1
85203
1
85205
1
87763
1
87194
1
88382
1
87193
1
88383
1
88024
1
17941
75401
75401
75401
75401
75401
17369
17369
11316
87942
87943
87944
81034
88022
88015
88016
87995
85983
87854
86569
86569
86480
86471
88654
88689
89976
89977
89932
40052
40052
40052
40052
87462
88255
87010
87910
2
1
2
3
4
5
1
2
4
1
1
1
1
1
1
1
1
1
1
1
2
1
1
1
1
1
1
1
1
2
3
4
1
1
1
1
AB4
AB4
AB4
AB4
AB4
Approval_Date
15‐Jul‐11
15‐Jul‐11
15‐Jul‐11
15‐Jul‐11
11‐Apr‐89
11‐Apr‐89
11‐Apr‐89
11‐Apr‐89
15‐Feb‐07
15‐Feb‐07
15‐Feb‐07
15‐Feb‐07
26‐Jan‐07
26‐Jan‐07
26‐Jan‐07
26‐Jan‐07
6‐Mar‐09
6‐Mar‐09
6‐Mar‐09
6‐Mar‐09
25‐Mar‐11
25‐Mar‐11
25‐Mar‐11
25‐Mar‐11
2‐Aug‐88
20‐Mar‐85
18‐Mar‐85
1‐Mar‐89
17‐Jul‐12
17‐Jul‐12
17‐Jul‐12
17‐Jul‐12
11‐Mar‐14
11‐Mar‐14
11‐Mar‐14
11‐Mar‐14
11‐Mar‐14
1‐Apr‐05
1‐Apr‐05
1‐Apr‐05
10‐Apr‐04
5‐Jun‐02
5‐Jun‐02
5‐Jun‐02
4‐Sep‐03
4‐Sep‐03
4‐Sep‐03
3‐Aug‐07
31‐Jan‐85
10‐May‐89
31‐Jan‐85
10‐May‐89
31‐Jan‐85
31‐Jan‐85
24‐May‐82
24‐May‐82
24‐May‐82
27‐Feb‐85
27‐Feb‐85
27‐Feb‐85
22‐Dec‐82
RLD
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
Yes
Yes
No
No
No
No
No
Yes
No
No
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Type
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
Applicant_Full_Name
APTALIS PHARMATECH INC
NORTEC DEVELOPMENT ASSOC INC
CENTRAL PHARMACEUTICALS INC
KV PHARMACEUTICAL CO
VIVUS INC
VIVUS INC
VIVUS INC
VIVUS INC
GLAXOSMITHKLINE LLC
GLAXOSMITHKLINE LLC
GLAXOSMITHKLINE LLC
ALLERGAN INC
NUMARK LABORATORIES INC
10‐Apr‐03
10‐Apr‐03
10‐Apr‐03
10‐Apr‐03
10‐Apr‐03
22‐Aug‐83
22‐Aug‐83
22‐Aug‐83
28‐Feb‐92
10‐Sep‐85
10‐Sep‐85
10‐Sep‐85
10‐Sep‐85
20‐Mar‐85
20‐Mar‐85
27‐May‐82
27‐May‐82
8‐Feb‐85
8‐Feb‐85
12‐Feb‐85
12‐Feb‐85
4‐Jan‐95
4‐Jan‐95
4‐Jan‐95
14‐Feb‐94
14‐Feb‐94
14‐Feb‐94
14‐Feb‐94
11‐May‐82
12‐Jun‐86
31‐Jan‐85
31‐Jan‐85
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
ALLERGAN HERBERT SKIN CARE DIV ALLERGAN INC
ACTIENT PHARMACEUTICALS LLC
SCHERING CORP
SCHERING CORP
SCHERING CORP
SCHERING CORP
WHITBY PHARMACEUTICALS INC
WHITBY PHARMACEUTICALS INC
SCHWARZ PHARMA INC
SCHWARZ PHARMA INC
ORTHO MCNEIL PHARMACEUTICAL INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
SANDOZ INC
RP SCHERER NORTH AMERICA DIV RP SCHERER CORP
Page 00024
Ingredient
CHLORPROMAZINE HYDROCHLORIDE
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TROSPIUM CHLORIDE
TROSPIUM CHLORIDE
CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX
CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX
DIAZEPAM
VERAPAMIL HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
HYDROCODONE BITARTRATE
AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE
DF;Route
CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL
CROMOLYN SODIUM
ALBUTEROL SULFATE
METHOXSALEN
CHLORDIAZEPOXIDE HYDROCHLORIDE
ISOTRETINOIN
ISOTRETINOIN
ISOTRETINOIN
ISOTRETINOIN
ISOTRETINOIN
ISOTRETINOIN
ISOTRETINOIN
CAPSULE;INHALATION
CAPSULE;INHALATION
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00025
Trade_Name
THORAZINE
THORAZINE
THORAZINE
THORAZINE
THORAZINE
TIAZAC
TIAZAC
TIAZAC
TIAZAC
TIAZAC
TIAZAC
TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES
TROKENDI XR
TROKENDI XR
TROKENDI XR
TROKENDI XR
TROSPIUM CHLORIDE
TROSPIUM CHLORIDE
TUSSICAPS
TUSSICAPS
VALRELEASE
VERELAN
VERELAN
VERELAN
VERELAN
VERELAN PM
VERELAN PM
VERELAN PM
X‐TROZINE L.A.
XIMINO
XIMINO
XIMINO
XIMINO
XIMINO
ZERIT XR
ZERIT XR
ZERIT XR
ZERIT XR
ZOHYDRO ER
ZOHYDRO ER
ZOHYDRO ER
ZOHYDRO ER
ZOHYDRO ER
ZOHYDRO ER
OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN
Applicant
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
VALEANT INTL
VALEANT INTL
VALEANT INTL
VALEANT INTL
VALEANT INTL
VALEANT INTL
MYLAN PHARMS INC
MYLAN PHARMS INC
KV PHARM
SUPERNUS PHARMS
SUPERNUS PHARMS
SUPERNUS PHARMS
SUPERNUS PHARMS
ACTAVIS LABS FL INC
PADDOCK LLC
ECR PHARMA
ECR PHARMA
ROCHE
ANCHEN PHARMS
ANCHEN PHARMS
ANCHEN PHARMS
DR REDDYS LABS LTD
DR REDDYS LABS LTD
DR REDDYS LABS LTD
MYLAN
MYLAN
MYLAN
ORCHID HLTHCARE
ORCHID HLTHCARE
ORCHID HLTHCARE
TEVA
TEVA
TEVA
TORRENT PHARMS LLC
TORRENT PHARMS LLC
TORRENT PHARMS LLC
VALEANT BERMUDA
VALEANT BERMUDA
VALEANT BERMUDA
WOCKHARDT
WOCKHARDT
WOCKHARDT
MYLAN
MYLAN
MYLAN
MYLAN
MYLAN
MYLAN
SHIRE RICHWOOD
RANBAXY LABS LTD
RANBAXY LABS LTD
RANBAXY LABS LTD
RANBAXY LABS LTD
RANBAXY LABS LTD
ZOGENIX INC
ZOGENIX INC
ZOGENIX INC
ZOGENIX INC
ZOGENIX INC
ZOGENIX INC
GASTROENTERO
INTAL
VENTOLIN ROTACAPS
8‐MOP
A‐POXIDE
A‐POXIDE
A‐POXIDE
A‐POXIDE
A‐POXIDE
A‐POXIDE
ABSORICA
ABSORICA
ABSORICA
ABSORICA
ACCUTANE
ACCUTANE
ACCUTANE
SANOFI AVENTIS US
GLAXOSMITHKLINE
VALEANT PHARM INTL
ABBOTT
ABBOTT
ABBOTT
ABBOTT
ABBOTT
ABBOTT
RANBAXY
RANBAXY
RANBAXY
RANBAXY
HOFFMANN LA ROCHE
HOFFMANN LA ROCHE
HOFFMANN LA ROCHE
Strength
30MG
75MG
150MG
200MG
300MG
120MG
180MG
240MG
300MG
360MG
420MG
2MG
4MG
120MG;5MG
25MG
50MG
100MG
200MG
60MG
60MG
EQ 4MG MALEATE;EQ 5MG BITARTRATE
EQ 8MG MALEATE;EQ 10MG BITARTRATE
15MG
EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE
EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE
EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE
EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE
EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE
EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE
EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE
EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE
EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE
EQ 37.5MG BASE
EQ 75MG BASE
EQ 150MG BASE
100MG
120MG
180MG
200MG
240MG
300MG
120MG
180MG
240MG
360MG
100MG
200MG
300MG
105MG
EQ 45MG BASE
EQ 67.5MG BASE
EQ 90MG BASE
EQ 112.5MG BASE
EQ 135MG BASE
37.5MG
50MG
75MG
100MG
10MG 15MG 20MG
30MG 40MG
50MG 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG
EQ 0.2MG BASE
10MG
5MG
5MG
10MG
10MG
25MG
25MG
10MG
20MG
30MG
40MG
10MG
20MG
40MG
Page 00026
Appl_Type
N
N
N
N
N
N
N
N
N
N
N
A
A
A
N
N
N
N
A
A
A
A
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
A
A
A
N
N
N
N
N
N
N
11120
16
11120
17
11120
18
11120
19
11120
20
20401
1 AB4
20401
2 AB4
20401
3 AB4
20401
4 AB4
20401
5 AB4
20401
6 AB4
201486
1 AB
201486
2 AB
71798
1
201635
1
201635
2
201635
3
201635
4
91289
1 AB
201291
1 AB
77273
2
77273
1
18179
1
78087
1 AB
78087
2 AB
78087
3 AB
200834
1 AB
200834
2 AB
200834
3 AB
78421
1 AB
78421
2 AB
78421
3 AB
78789
1 AB
78789
2 AB
78789
3 AB
91123
1 AB
91123
2 AB
91123
3 AB
76565
1 AB
76565
2 AB
76565
3 AB
90899
1 AB
90899
2 AB
90899
3 AB
90071
1 AB
90071
2 AB
90071
3 AB
78865
1 AB
78865
2 AB
78865
3 AB
90174
1 AB
90174
2 AB
90174
3 AB
78306
1 AB
75138
1 AB
75138
2 AB
78306
2 AB
75138
3 AB
78306
3 AB
19614
1 AB
19614
3 AB
19614
2 AB
19614
4
20943
1 AB
20943
2 AB
20943
3 AB
87371
1
201922
1
201922
2
201922
3
201922
4
201922
5
21453
1
21453
2
21453
3
21453
4
202880
1
202880
2
202880
3
202880
4
202880
5
202880
6
50824
1
16990
19489
9048
85447
85517
85447
85518
85447
85513
21951
21951
21951
21951
18662
18662
18662
1
1
1
1
1
2
1
3
1
1
2
3
4
2
4
3
BX
BX
BX
BX
Approval_Date
11‐Sep‐95
11‐Sep‐95
11‐Sep‐95
11‐Sep‐95
11‐Sep‐95
16‐Oct‐98
31‐Oct‐13
31‐Oct‐13
16‐Mar‐89
16‐Aug‐13
16‐Aug‐13
16‐Aug‐13
16‐Aug‐13
12‐Oct‐12
24‐May‐13
24‐Sep‐07
24‐Sep‐07
16‐Mar‐12
16‐Mar‐12
16‐Mar‐12
14‐Apr‐11
14‐Apr‐11
14‐Apr‐11
6‐May‐11
6‐May‐11
6‐May‐11
1‐Jun‐11
1‐Jun‐11
1‐Jun‐11
11‐Jul‐11
11‐Jul‐11
11‐Jul‐11
28‐Jun‐10
28‐Jun‐10
28‐Jun‐10
1‐Jun‐11
1‐Jun‐11
1‐Jun‐11
15‐Apr‐11
15‐Apr‐11
15‐Apr‐11
14‐Apr‐11
14‐Apr‐11
14‐Apr‐11
14‐Apr‐11
14‐Apr‐11
14‐Apr‐11
9‐Aug‐07
20‐Apr‐99
20‐Apr‐99
9‐Aug‐07
20‐Apr‐99
9‐Aug‐07
29‐May‐90
9‐Jan‐92
29‐May‐90
10‐May‐96
25‐Nov‐98
25‐Nov‐98
25‐Nov‐98
24‐Aug‐82
11‐Jul‐12
11‐Jul‐12
11‐Jul‐12
11‐Jul‐12
11‐Jul‐12
31‐Dec‐02
31‐Dec‐02
31‐Dec‐02
31‐Dec‐02
25‐Oct‐13
25‐Oct‐13
25‐Oct‐13
25‐Oct‐13
25‐Oct‐13
25‐Oct‐13
8‐Feb‐11
RLD
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
Yes
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
Yes
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
Yes
Type
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
Applicant_Full_Name
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
SUPERNUS PHARMACEUTICALS INC
ECR PHARMA
ECR PHARMA
HOFFMANN LA ROCHE INC
ANCHEN PHARMACEUTICALS, INC
AUROBINDO PHARMA LIMITED
ORCHID HEALTHCARE
ORCHID HEALTHCARE
ORCHID HEALTHCARE
TORRENT PHARMACEUTICALS LLC
VALEANT INTERNATIONAL BERMUDA
WOCKHARDT LTD
WOCKHARDT LTD
WOCKHARDT LTD
SHIRE RICHWOOD INC
RANBAXY LABORATORIES LTD
ZOGENIX INC
ZOGENIX INC
ZOGENIX INC
ZOGENIX INC
ZOGENIX INC
ZOGENIX INC
GASTROENTERO LOGIC LLC
4‐May‐88
25‐May‐12
25‐May‐12
25‐May‐12
25‐May‐12
7‐May‐82
28‐Mar‐83
7‐May‐82
No
No
Yes
No
No
No
No
No
No
No
No
No
Yes
No
No
No
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
GLAXOSMITHKLINE
ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
RANBAXY INC
RANBAXY INC
RANBAXY INC
RANBAXY INC
Page 00027
Ingredient
ACEBUTOLOL HYDROCHLORIDE
ACETAMINOPHEN; CODEINE PHOSPHATE
ACETAMINOPHEN; HYDROCODONE BITARTRATE
ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
TETRACYCLINE HYDROCHLORIDE
ACITRETIN
ACITRETIN
ACITRETIN
ACITRETIN
URSODIOL
URSODIOL
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
NIFEDIPINE
NIFEDIPINE
PHENTERMINE HYDROCHLORIDE
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
IBUPROFEN
IBUPROFEN
DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
VITAMIN A PALMITATE
AMPRENAVIR
AMPRENAVIR
ANAGRELIDE HYDROCHLORIDE
NETUPITANT; PALONOSETRON HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE
ORLISTAT
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
PALONOSETRON HYDROCHLORIDE
VITAMIN A PALMITATE
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
AMANTADINE HYDROCHLORIDE
BROMODIPHENHYDRAMINE HYDROCHLORIDE
AMPICILLIN/AMPICILLIN TRIHYDRATE
LUBIPROSTONE
LUBIPROSTONE
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00028
Trade_Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
ACHROMYCIN V
ACHROMYCIN V
ACITRETIN
ACITRETIN
ACITRETIN
ACITRETIN
ACTIGALL
ACTIGALL
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ACYCLOVIR
ADALAT
ADALAT
ADIPEX‐P
ADVIL COLD AND SINUS
ADVIL LIQUI‐GELS
ADVIL MIGRAINE LIQUI‐GELS
ADVIL PM
AFAXIN
AGENERASE
AGENERASE
AGRYLIN
AGRYLIN
AKYNZEO
ALLAY
ALLEGRA
ALLI
Applicant
AMNEAL PHARM
AMNEAL PHARM
MYLAN
MYLAN
WATSON LABS
WATSON LABS
TEVA
TEVA
TEVA
CENT PHARMS
MIKART
MIKART
MIKART
MIKART
WRASER PHARMS LLC
HERITAGE PHARMS INC
HERITAGE PHARMS INC
BARR LABS INC
BARR LABS INC
TEVA PHARMS USA
TEVA PHARMS USA
WATSON PHARMS
WATSON PHARMS
ACTAVIS ELIZABETH
APOTEX INC
CADILA PHARMS LTD
DAVA PHARMS INC
DAVA PHARMS INC
HERITAGE PHARMS INC
LEK PHARM
MYLAN
MYLAN
RANBAXY
ROXANE
STASON
TEVA
TEVA
TEVA PHARMS
WATSON LABS
BAYER PHARMS
BAYER PHARMS
TEVA
PFIZER
PFIZER
PFIZER
PFIZER
STERLING WINTHROP
GLAXOSMITHKLINE
GLAXOSMITHKLINE
SHIRE LLC
SHIRE LLC
HELSINN HLTHCARE
IVAX PHARMS
SANOFI AVENTIS US
GLAXOSMITHKLINE CONS
ALOXI
ALPHALIN
ALTACE
ALTACE
ALTACE
ALTACE
AMBODRYL
AMCILL
AMCILL
AMITIZA
AMITIZA
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
HELSINN HLTHCARE
LILLY
KING PHARMS
KING PHARMS
KING PHARMS
KING PHARMS
ACTAVIS ELIZABETH
BANNER PHARMACAPS
SANDOZ
USL PHARMA
WATSON LABS
PARKE DAVIS
PARKE DAVIS
PARKE DAVIS
SUCAMPO PHARMA LLC
SUCAMPO PHARMA LLC
APOTEX INC
APOTEX INC
APOTEX INC
APOTEX INC
APOTEX INC
APOTEX INC
DR REDDYS LABS INC
DR REDDYS LABS INC
DR REDDYS LABS INC
DR REDDYS LABS INC
DR REDDYS LABS INC
DR REDDYS LABS INC
LUPIN PHARMS
LUPIN PHARMS
LUPIN PHARMS
LUPIN PHARMS
LUPIN PHARMS
LUPIN PHARMS
MYLAN
MYLAN
MYLAN
Strength
EQ 200MG BASE
EQ 400MG BASE
EQ 200MG BASE
EQ 400MG BASE
EQ 200MG BASE
EQ 400MG BASE
300MG;15MG
300MG;30MG
300MG;60MG
500MG;5MG
150MG;180MG;15MG
150MG;180MG;30MG
150MG;180MG;60MG
356.4MG;30MG;16MG
356.4MG;30MG;16MG
250MG
500MG
10MG
25MG
17.5MG
22.5MG
150MG
300MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
200MG
10MG
20MG
37.5MG
EQ 200MG FREE ACID AND POTASSIUM SALT;30MG
EQ 200MG FREE ACID AND POTASSIUM SALT
25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
EQ 50,000 UNITS BASE
50MG
150MG
EQ 0.5MG BASE
EQ 1MG BASE
300MG;EQ 0.5MG BASE
500MG;5MG
60MG
60MG
EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
1.25MG
2.5MG
5MG
10MG
100MG
100MG
100MG
100MG
100MG
25MG
EQ 250MG BASE
EQ 500MG BASE
8MCG
24MCG
EQ 2.5MG BASE;10MG
EQ 5MG BASE;10MG
EQ 5MG BASE;20MG
EQ 5MG BASE;40MG
EQ 10MG BASE;20MG
EQ 10MG BASE;40MG
EQ 2.5MG BASE;10MG
EQ 5MG BASE;10MG
EQ 5MG BASE;20MG
EQ 5MG BASE;40MG
EQ 10MG BASE;20MG
EQ 10MG BASE;40MG
EQ 2.5MG BASE;10MG
EQ 5MG BASE;10MG
EQ 5MG BASE;20MG
EQ 5MG BASE;40MG
EQ 10MG BASE;20MG
EQ 10MG BASE;40MG
EQ 2.5MG BASE;10MG
EQ 5MG BASE;10MG
EQ 5MG BASE;20MG
EQ 5MG BASE;40MG
EQ 10MG BASE;20MG
EQ 10MG BASE;40MG
EQ 2.5MG BASE;10MG
EQ 5MG BASE;10MG
EQ 5MG BASE;20MG
Page 00029
Appl_Type
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
A
A
A
A
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
A
N
N
N
N
A
N
N
N
N
N
A
N
N
N
A
N
N
N
N
A
A
A
A
A
N
A
A
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
75047
1 AB
75047
2 AB
74288
1 AB
74288
2 AB
74007
1
74007
2
88537
1
88324
1
88599
1
88898
1
81095
1
81096
1
81097
1
40109
1
40688
1
50278
3 AB
50278
1 AB
91455
1 AB
91455
2 AB
202897
1 AB
202897
2 AB
19594
1
19594
2 AB
74906
1
75677
1 AB
201445
1 AB
74833
1 AB
74872
1
74889
1
74674
1
74750
1
74727
1 AB
74977
1
74975
1 AB
74570
2
75090
1 AB
74578
1 AB
74828
1
74914
1
75101
1
19478
1
19478
2
88023
1 AA
21374
1
20402
1
20402
2
21393
1
83187
1
21007
1
21007
2
20333
1 AB
20333
2
205718
1
89907
1
20625
1
21887
1
22233
80883
19901
19901
19901
19901
77659
78720
71293
70589
71382
7984
62041
62041
21908
21908
91431
91431
91431
91431
91431
91431
202239
202239
202239
202239
202239
202239
77183
77183
77183
90149
77183
90149
78466
78466
78466
78466
78466
78466
77375
77375
77375
1
1
1
2
3
4
1
1
1
1
1
1
1
2
2
1
1
2
3
4
5
6
1
2
3
4
5
6
1
2
3
1
4
2
1
2
3
5
4
6
1
2
3
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
Approval_Date
30‐Dec‐99
30‐Dec‐99
24‐Apr‐95
24‐Apr‐95
18‐Oct‐95
18‐Oct‐95
4‐Jun‐84
29‐Dec‐83
1‐Jun‐84
27‐Mar‐85
26‐Oct‐90
26‐Oct‐90
26‐Oct‐90
26‐Aug‐97
3‐Apr‐07
4‐Apr‐13
4‐Apr‐13
4‐Apr‐13
4‐Apr‐13
31‐Dec‐87
31‐Dec‐87
26‐Aug‐97
28‐Sep‐05
6‐Mar‐14
22‐Apr‐97
22‐Apr‐97
31‐Oct‐97
22‐Apr‐97
22‐Apr‐97
22‐Apr‐97
13‐Apr‐98
30‐Sep‐98
22‐Apr‐97
26‐Jan‐99
22‐Apr‐97
22‐Apr‐97
26‐Nov‐97
15‐Apr‐98
27‐Nov‐85
17‐Sep‐86
2‐Aug‐83
30‐May‐02
20‐Apr‐95
16‐Mar‐00
21‐Dec‐05
15‐Apr‐99
15‐Apr‐99
14‐Mar‐97
14‐Mar‐97
10‐Oct‐14
13‐Jan‐89
25‐Jul‐96
7‐Feb‐07
RLD
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
Yes
No
No
Yes
Type
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
DISCN
RX
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
OTC
OTC
OTC
OTC
DISCN
DISCN
DISCN
RX
DISCN
RX
DISCN
DISCN
OTC
Applicant_Full_Name
AMNEAL PHARMACEUTICAL
AMNEAL PHARMACEUTICAL
MIKART INC
MIKART INC
MIKART INC
MIKART INC
WRASER PHARMACEUTICALS LLC
WATSON PHARMACEUTICALS INC
CADILA PHARMACEUTICALS LTD
DAVA PHARMACEUTICALS INC
LEK PHARMACEUTICAL AND CHEMICAL CO DD
ROXANE LABORATORIES INC
STASON INDUSTRIAL CORP
BAYER PHARMACEUTICALS CORP
PFIZER INC
PFIZER INC
PFIZER INC
PFIZER INC
STERLING WINTHROP INC
GLAXOSMITHKLINE
GLAXOSMITHKLINE
SHIRE DEVELOPMENT LLC
SHIRE DEVELOPMENT LLC
HELSINN HEALTHCARE SA
IVAX PHARMACEUTICALS INC
GLAXOSMITHKLINE CONSUMER HEALTHCARE
22‐Aug‐08
28‐Jan‐91
28‐Jan‐91
28‐Jan‐91
28‐Jan‐91
23‐Feb‐06
29‐May‐08
18‐Feb‐87
5‐Aug‐86
21‐Jan‐87
29‐Apr‐08
31‐Jan‐06
30‐Dec‐13
30‐Dec‐13
30‐Dec‐13
30‐Dec‐13
30‐Dec‐13
30‐Dec‐13
5‐Sep‐12
5‐Sep‐12
5‐Sep‐12
5‐Sep‐12
5‐Sep‐12
5‐Sep‐12
15‐Apr‐10
15‐Apr‐10
15‐Apr‐10
5‐Jul‐11
15‐Apr‐10
5‐Jul‐11
5‐Feb‐10
5‐Feb‐10
5‐Feb‐10
5‐Jul‐11
5‐Feb‐10
5‐Jul‐11
21‐May‐10
21‐May‐10
21‐May‐10
No
No
No
No
No
Yes
No
No
Yes
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
DISCN
DISCN
RX
RX
RX
RX
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
HELSINN HEALTHCARE SA
ELI LILLY AND CO
SANDOZ INC
USL PHARMA INC
SUCAMPO PHARMA AMERICAS LLC
SUCAMPO PHARMA AMERICAS LLC
APOTEX INC
APOTEX INC
APOTEX INC
APOTEX INC
APOTEX INC
APOTEX INC
DR REDDYS LABORATORIES INC
LUPIN PHARMACEUTICALS INC
Page 00030
Ingredient
ISOTRETINOIN
ISOTRETINOIN
ISOTRETINOIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
CHLORAMPHENICOL
CLOMIPRAMINE HYDROCHLORIDE
FLUCYTOSINE
FLUCYTOSINE
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
CEPHRADINE
CEPHRADINE
FENOFIBRATE
FENOFIBRATE
FENOFIBRATE
FENOFIBRATE
FENOFIBRATE
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
SULFINPYRAZONE
CAPSULE;ORAL
Page 00031
Trade_Name
AMNESTEEM
AMNESTEEM
AMNESTEEM
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXIL
AMOXIL
AMOXIL
AMOXIL
AMPHICOL
AMPICILLIN TRIHYDRATE
ANAFRANIL
ANAFRANIL
ANAFRANIL
ANCOBON
ANCOBON
ANOQUAN
ANSPOR
ANSPOR
ANTARA (MICRONIZED)
ANTARA (MICRONIZED)
ANTARA (MICRONIZED)
ANTARA (MICRONIZED)
ANTARA (MICRONIZED)
Applicant
MYLAN
MYLAN
MYLAN
PAR PHARM
PAR PHARM
PAR PHARM
PAR PHARM
PAR PHARM
PAR PHARM
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS INC
WATSON LABS INC
MYLAN PHARMS INC
MYLAN PHARMS INC
MYLAN PHARMS INC
AM ANTIBIOTICS
AM ANTIBIOTICS
AUROBINDO
AUROBINDO
DAVA PHARMS INC
DAVA PHARMS INC
HIKMA PHARMS
HIKMA PHARMS
LABS ATRAL
LABS ATRAL
MYLAN
MYLAN
RANBAXY
RANBAXY
SANDOZ
SANDOZ
TEVA
TEVA
TEVA
TEVA
TEVA
TEVA
DR REDDYS LABS INC
DR REDDYS LABS INC
GLAXOSMITHKLINE
GLAXOSMITHKLINE
FERRANTE
AM ANTIBIOTICS
AM ANTIBIOTICS
DAVA PHARMS INC
DAVA PHARMS INC
LEDERLE
LEDERLE
MYLAN
MYLAN
PUREPAC PHARM
PUREPAC PHARM
SANDOZ
SANDOZ
TEVA
TEVA
VITARINE
VITARINE
MALLINCKRODT LLC
MALLINCKRODT LLC
MALLINCKRODT LLC
BARR
BARR
IMPAX LABS
IMPAX LABS
MYLAN
MYLAN
MYLAN PHARMS INC
MYLAN PHARMS INC
ROXANE
ROXANE
SANDOZ INC
SANDOZ INC
WATSON LABS
WATSON LABS
VALEANT
VALEANT
SHIRE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
LUPIN ATLANTIS
LUPIN ATLANTIS
LUPIN ATLANTIS
LUPIN ATLANTIS
LUPIN ATLANTIS
ANTURANE
NOVARTIS
Strength
EQ 5MG BASE;40MG
EQ 10MG BASE;20MG
EQ 10MG BASE;40MG
EQ 2.5MG BASE;10MG
EQ 5MG BASE;10MG
EQ 5MG BASE;20MG
EQ 5MG BASE;40MG
EQ 10MG BASE;20MG
EQ 10MG BASE;40MG
EQ 2.5MG BASE;10MG
EQ 5MG BASE;10MG
EQ 5MG BASE;20MG
EQ 5MG BASE;40MG
EQ 10MG BASE;20MG
EQ 10MG BASE;40MG
EQ 2.5MG BASE;10MG
EQ 5MG BASE;10MG
EQ 5MG BASE;20MG
EQ 10MG BASE;20MG
EQ 5MG BASE;40MG
EQ 10MG BASE;40MG
10MG
20MG
40MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
250MG
250MG
500MG
500MG
500MG
250MG
500MG
250MG
500MG
100MG
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
25MG
50MG
75MG
EQ 0.5MG BASE
EQ 1MG BASE
EQ 0.5MG BASE
EQ 1MG BASE
EQ 0.5MG BASE
EQ 1MG BASE
EQ 0.5MG BASE
EQ 1MG BASE
EQ 0.5MG BASE
EQ 1MG BASE
EQ 0.5MG BASE
EQ 1MG BASE
EQ 0.5MG BASE
EQ 1MG BASE
EQ 0.5MG BASE
EQ 1MG BASE
250MG
500MG
325MG;50MG;40MG
250MG
500MG
30MG
43MG
87MG
90MG
130MG
Page 00032
Appl_Type
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
A
A
A
N
N
N
N
N
N
79047
1 AB
77375
4 AB
79047
2 AB
78381
1 AB
78381
2 AB
78381
3 AB
78381
5 AB
78381
4 AB
78381
6 AB
77179
1 AB
77179
2 AB
77179
3 AB
77179
5 AB
77179
4 AB
77179
6 AB
77890
1 AB
77890
2 AB
77890
3 AB
77890
4 AB
90364
1 AB
90364
2 AB
75945
1 AB
75945
2 AB
75945
3 AB
62058
1 AB
62058
2 AB
65271
1 AB
65271
2 AB
62884
1 AB
62881
1 AB
65291
1 AB
65291
2 AB
62528
1
62528
2
62067
1
62067
2
65016
1 AB
65016
2 AB
64076
1 AB
64076
2 AB
61926
1 AB
62853
1
63030
1
61926
3 AB
62854
1
63031
1
62216
1 AB
62216
4 AB
50459
1
50459
2
60058
1
61602
1
61602
2
62883
1 AB
62882
1 AB
60765
1
60765
2
62208
1
62208
2
61755
1
61755
2
61853
1
61853
2
64082
1 AB
64082
2 AB
61502
1
61502
2
61387
1
61387
3
19906
1 AB
19906
2 AB
19906
3 AB
76530
1 AB
76530
2 AB
76910
1 AB
76910
2 AB
76468
1 AB
76468
2 AB
76811
1 AB
76811
2 AB
77613
1 AB
77613
2 AB
76489
1
76489
2
76683
1
76683
2
76417
1
76417
2
17001
1 AB
17001
2 AB
87628
1
61859
1
61859
2
21695
4
21695
1 AB
21695
2
21695
5
21695
3 AB
11556
4
Approval_Date
5‐Jul‐11
21‐May‐10
5‐Jul‐11
29‐Jul‐10
29‐Jul‐10
29‐Jul‐10
29‐Jul‐10
29‐Jul‐10
29‐Jul‐10
18‐May‐07
18‐May‐07
18‐May‐07
5‐Jul‐11
18‐May‐07
5‐Jul‐11
14‐Oct‐10
14‐Oct‐10
14‐Oct‐10
14‐Oct‐10
5‐Jul‐11
5‐Jul‐11
8‐Nov‐02
8‐Nov‐02
8‐Nov‐02
9‐Nov‐05
9‐Nov‐05
25‐Feb‐88
25‐Feb‐88
5‐Feb‐07
5‐Feb‐07
7‐Aug‐85
7‐Aug‐85
8‐Apr‐99
8‐Apr‐99
30‐Sep‐94
30‐Sep‐94
22‐Dec‐87
28‐Feb‐89
22‐Dec‐87
28‐Feb‐89
25‐Feb‐88
25‐Feb‐88
29‐Aug‐95
29‐Aug‐95
29‐Dec‐89
29‐Dec‐89
29‐Dec‐89
18‐Apr‐05
18‐Apr‐05
18‐Apr‐05
18‐Apr‐05
18‐Apr‐05
18‐Apr‐05
18‐Apr‐05
18‐Apr‐05
27‐Jun‐06
27‐Jun‐06
18‐Apr‐05
18‐Apr‐05
18‐Apr‐05
18‐Apr‐05
18‐Apr‐05
18‐Apr‐05
1‐Oct‐86
18‐Oct‐13
30‐Nov‐04
30‐Nov‐04
18‐Oct‐13
30‐Nov‐04
RLD
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
Yes
Type
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
RX
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
RX
RX
DISCN
RX
RX
Applicant_Full_Name
AMERICAN ANTIBIOTICS INC
AMERICAN ANTIBIOTICS INC
HIKMA PHARMACEUTICALS
LABORATORIOS ATRAL SARL
RANBAXY PHARMACEUTICALS INC
SANDOZ INC
SANDOZ INC
GLAXOSMITHKLINE
GLAXOSMITHKLINE
JOHN J FERRANTE
AMERICAN ANTIBIOTICS LLC
PUREPAC PHARMACEUTICAL CO
SANDOZ INC
SANDOZ INC
VITARINE PHARMACEUTICALS INC
MALLINCKRODT LLC
MALLINCKRODT LLC
MALLINCKRODT LLC
MYLAN LABORATORIES INC
SANDOZ INC
SANDOZ INC
WATSON LABORATORIES
WATSON LABORATORIES
GLAXOSMITHKLINE
GLAXOSMITHKLINE
LUPIN ATLANTIS HOLDINGS SA
No
DISCN NOVARTIS PHARMACEUTICALS CORP
Page 00033
Ingredient
APREPITANT
APREPITANT
APREPITANT
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
TIPRANAVIR
VITAMIN A
VITAMIN A
ASPIRIN
ATAZANAVIR SULFATE
ATAZANAVIR SULFATE
ATAZANAVIR SULFATE
ATAZANAVIR SULFATE
ATOMOXETINE HYDROCHLORIDE
CLOFIBRATE
NORTRIPTYLINE HYDROCHLORIDE
DUTASTERIDE
NIZATIDINE
NIZATIDINE
PHENYLBUTAZONE
OXACILLIN SODIUM
OXACILLIN SODIUM
OXACILLIN SODIUM
OXACILLIN SODIUM
BALSALAZIDE DISODIUM
ACETAMINOPHEN; BUTALBITAL
DIPHENHYDRAMINE HYDROCHLORIDE
LEVODOPA
LEVODOPA
LEVODOPA
DICYCLOMINE HYDROCHLORIDE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BEXAROTENE
IPODATE SODIUM
TYROPANOATE SODIUM
PAROXETINE MESYLATE
BROMOCRIPTINE MESYLATE
THEOPHYLLINE
THEOPHYLLINE
BUDESONIDE
BUDESONIDE
BUSPIRONE HYDROCHLORIDE
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
ASPIRIN; BUTALBITAL; CAFFEINE
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
PHENYLBUTAZONE
BUTABARBITAL SODIUM
BUTABARBITAL SODIUM
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00034
Trade_Name
APREPITANT
APREPITANT
APREPITANT
APRESAZIDE
APRESAZIDE
APRESAZIDE
APTIVUS
AQUASOL A
AQUASOL A
ASPIRIN
ATAZANAVIR SULFATE
ATAZANAVIR SULFATE
ATAZANAVIR SULFATE
ATAZANAVIR SULFATE
ATROMID‐S
AVENTYL HYDROCHLORIDE
AVENTYL HYDROCHLORIDE
AVODART
AXID
AXID
AZOLID
BACTOCILL
BACTOCILL
BACTOCILL
BACTOCILL
BANCAP
BANCAP HC
BENADRYL
BENADRYL
BENDOPA
BENDOPA
BENDOPA
BENTYL
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BENZONATATE
BEXAROTENE
BILIVIST
BILOPAQUE
BRISDELLE
BRISTACYCLINE
BRISTACYCLINE
BRISTACYCLINE
BRISTACYCLINE
BRONKODYL
BRONKODYL
BUCET
BUDESONIDE
BUDESONIDE
BUSPAR
BUSPAR
BUSPAR
BUSPAR
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
BUTALBITAL, ASPIRIN AND CAFFEINE
BUTALBITAL, ASPIRIN AND CAFFEINE
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
BUTALIBITAL, ACETAMINOPHEN AND CAFFEINE
BUTAZOLIDIN
BUTICAPS
BUTICAPS
Applicant
SANDOZ
SANDOZ
SANDOZ
NOVARTIS
NOVARTIS
NOVARTIS
ASTRAZENECA
ASTRAZENECA
PLX PHARMA
TEVA PHARMS USA
TEVA PHARMS USA
TEVA PHARMS USA
TEVA PHARMS USA
WYETH AYERST
LILLY
LILLY
GLAXOSMITHKLINE
SMITHKLINE BEECHAM
SMITHKLINE BEECHAM
SANOFI AVENTIS US
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
APOTEX INC
MYLAN
ROXANE
FOREST PHARMS
FOREST PHARMS
MCNEIL CONS
MCNEIL CONS
VALEANT PHARM INTL
VALEANT PHARM INTL
VALEANT PHARM INTL
FOREST LABS INC
BANNER PHARMACAPS
BANNER PHARMACAPS
MIKART
MIKART
MIKART
NESHER PHARMS
NESHER PHARMS
ORIT LABS LLC
ORIT LABS LLC
SUN PHARM INDS INC
SUN PHARM INDS INC
THE PHARMA NETWORK
THE PHARMA NETWORK
THEPHARMANETWORK LLC
ZYDUS PHARMS USA
ZYDUS PHARMS USA
BANNER PHARMACAPS
BAYER HLTHCARE
GE HEALTHCARE
NOVEN THERAP
BRISTOL
BRISTOL
BRISTOL
BRISTOL
LEK PHARM
MYLAN
SANOFI AVENTIS US
SANOFI AVENTIS US
MALLINCKRODT
BARR LABS DIV TEVA
MYLAN
GRAHAM DM
GRAHAM DM
GRAHAM DM
HIKMA PHARMS LLC
MALLINCKRODT
MIKART
NEXGEN PHARMA
ABLE
HIKMA INTL PHARMS
NEXGEN PHARMA INC
NEXGEN PHARMA INC
VINTAGE PHARMS
MUTUAL PHARM
WATSON LABS
NEXGEN PHARMA INC
STEVENS J
VINTAGE PHARMS LLC
WATSON LABS
GILBERT LABS
NOVARTIS
MEDPOINTE PHARM HLC
MEDPOINTE PHARM HLC
Strength
40MG
80MG
125MG
25MG;25MG
50MG;50MG
100MG;50MG
250MG
25,000USP UNITS
50,000USP UNITS
325MG
EQ 100MG BASE
EQ 150MG BASE
EQ 200MG BASE
EQ 300MG BASE
18MG
25MG
40MG
60MG
80MG
100MG
500MG
EQ 10MG BASE
EQ 25MG BASE
0.5MG
150MG
300MG
100MG
EQ 250MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 500MG BASE
750MG
750MG
750MG
325MG;50MG
500MG;5MG
25MG
50MG
100MG
250MG
500MG
10MG
100MG
200MG
100MG
150MG
200MG
100MG
200MG
100MG
200MG
100MG
200MG
100MG
200MG
150MG
100MG
200MG
75MG
500MG
750MG
EQ 7.5MG BASE
250MG
250MG
500MG
500MG
EQ 5MG BASE
EQ 5MG BASE
EQ 5MG BASE
100MG
200MG
650MG;50MG
3MG
3MG
5MG
7.5MG
10MG
15MG
325MG;50MG;40MG
325MG;50MG;40MG
325MG;50MG;40MG
500MG;50MG;40MG
325MG;50MG;40MG
325MG;50MG;40MG
300MG;50MG;40MG
325MG;50MG;40MG;30MG
325MG;50MG;40MG
325MG;50MG;40MG
325MG;50MG;40MG
100MG
15MG
30MG
Page 00035
Appl_Type
A
A
A
A
A
A
N
A
A
N
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
A
A
90999
1 AB
90999
2 AB
90999
3 AB
84735
1
84810
1
84811
1
21814
1
83080
2
83080
1
203697
1
91673
1
91673
2 AB
91673
3 AB
91673
4 AB
79017
1
79017
2
79017
3
79017
4
79017
5
79017
6
16099
2
14684
1
14684
2
21319
1 AB
19508
1
19508
2
87260
1
61336
1
62241
1
61336
2
62241
2
77883
1 AB
77807
1 AB
77806
1 AB
88889
1
87961
1
5845
7
5845
1
16948
3
16948
1
16948
2
7409
3 AB
81297
1 AA
81297
2 AA
40851
1 AA
40851
2 AA
40851
3 AA
40795
1
40795
2
40682
1 AA
40682
2 AA
40587
1 AA
40587
2 AA
40627
1 AA
40749
1 AA
201209
1 AA
40597
1 AA
40597
2 AA
203174
1
87768
1
13731
1
204516
1
61658
1
61888
1
61658
2
61888
2
75100
1
77226
1 AB
78899
1 AB
85264
1
85264
2
88991
1
90379
1 AB
90410
1 AB
21190
1
21190
2
21190
3
21190
4
88743
1
88765
1
89067
1
40261
1
88758
1
89007
1
40885
1
76528
1
75618
1 AB
76560
2
76560
1 AB
75929
1 AB
78149
1
86231
2
75231
1 AB
74951
1 AB
75351
1
74359
1
88825
1
8319
9
85381
1
85381
2
Approval_Date
24‐Sep‐12
24‐Sep‐12
24‐Sep‐12
22‐Jun‐05
14‐Jan‐13
22‐Apr‐14
22‐Apr‐14
22‐Apr‐14
22‐Apr‐14
17‐Sep‐10
17‐Sep‐10
17‐Sep‐10
17‐Sep‐10
17‐Sep‐10
17‐Sep‐10
20‐Nov‐01
12‐Apr‐88
12‐Apr‐88
28‐Dec‐07
28‐Dec‐07
28‐Dec‐07
16‐Jan‐86
17‐Mar‐83
15‐Oct‐84
29‐Jan‐93
30‐Oct‐07
9‐Nov‐09
9‐Nov‐09
9‐Nov‐09
31‐Oct‐07
31‐Oct‐07
30‐Jul‐07
30‐Jul‐07
19‐Mar‐08
19‐Mar‐08
30‐Mar‐07
25‐Jul‐07
24‐Sep‐14
8‐Jun‐07
8‐Jun‐07
12‐Aug‐14
11‐Aug‐82
28‐Jun‐13
10‐Dec‐98
4‐Apr‐05
30‐Jul‐08
28‐Jun‐85
2‐Apr‐14
16‐May‐11
20‐Dec‐00
20‐Dec‐00
20‐Dec‐00
20‐Dec‐00
18‐Jul‐85
27‐Mar‐85
19‐Apr‐85
28‐Oct‐98
27‐Mar‐85
17‐Mar‐86
16‐Nov‐09
21‐Aug‐03
23‐Mar‐01
19‐Jul‐12
10‐Jun‐04
22‐Apr‐02
13‐Jun‐07
12‐Feb‐85
30‐Nov‐01
31‐Aug‐98
5‐Mar‐99
31‐Aug‐95
5‐Dec‐84
RLD
No
No
No
No
No
No
Yes
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Type
RX
RX
RX
DISCN
DISCN
DISCN
RX
DISCN
DISCN
OTC
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
RX
RX
RX
RX
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
Applicant_Full_Name
SANDOZ INC
SANDOZ INC
SANDOZ INC
ASTRAZENECA LP
ASTRAZENECA LP
PLX PHARMA INC
ELI LILLY AND CO
ELI LILLY AND CO
GLAXOSMITHKLINE
SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
FOREST PHARMACEUTICALS INC
FOREST PHARMACEUTICALS INC
MCNEIL CONSUMER HEALTHCARE
MIKART INC
MIKART INC
MIKART INC
ORIT LABORATORIES LLC
SUN PHARMACEUTICAL INDUSTRIES INC
THE PHARMA NETWORK LLC
THE PHARMA NETWORK LLC
BAYER HEALTHCARE PHARMACEUTICALS INC
GE HEALTHCARE
NOVEN THERAPEUTICS LLC
BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
LEK PHARMACEUTICAL AND CHEMICAL CO DD
MALLINCKRODT CHEMICAL INC
BARR LABORATORIES INC SUB TEVA PHARMACEUTICALS USA
BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
HIKMA PHARMACEUTICALS LLC
MIKART INC
NEXGEN PHARMA INC
HIKMA INTERNATIONAL PHARMACEUTICALS LLC
NEXGEN PHARMA INC
NEXGEN PHARMA INC
VINTAGE PHARMACEUTICALS INC
MUTUAL PHARMACEUTICAL CO INC
NEXGEN PHARMA INC
JEROME STEVENS PHARMACEUTICALS INC
VINTAGE PHARMACEUTICALS LLC
GILBERT LABORATORIES
Page 00036
Ingredient
BUTABARBITAL SODIUM
BUTABARBITAL SODIUM
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCIUM ACETATE
CALCIUM ACETATE
CALCIUM ACETATE
CALCIUM ACETATE
CALCIFEDIOL
CALCIFEDIOL
CEFACLOR
CEFACLOR
CEFTIBUTEN DIHYDRATE
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEFDINIR
CEFDINIR
CEFDINIR
CEFDINIR
CEFDINIR
CELECOXIB
CELECOXIB
CELECOXIB
CELECOXIB
CELECOXIB
CELECOXIB
CELECOXIB
CELECOXIB
CELECOXIB
MYCOPHENOLATE MOFETIL
METHSUXIMIDE
METHSUXIMIDE
PRAZEPAM
PRAZEPAM
PRAZEPAM
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00037
Trade_Name
BUTICAPS
BUTICAPS
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCIUM ACETATE
CALCIUM ACETATE
CALCIUM ACETATE
CALCIUM ACETATE
CALDEROL
CALDEROL
CARDENE
CARDENE
CECLOR
CECLOR
CEDAX
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFDINIR
CEFDINIR
CEFDINIR
CEFDINIR
CEFDINIR
CELEBREX
CELEBREX
CELEBREX
CELEBREX
CELECOXIB
CELECOXIB
CELECOXIB
CELECOXIB
CELECOXIB
CELLCEPT
CELONTIN
CELONTIN
CENTRAX
CENTRAX
CENTRAX
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
Applicant
MEDPOINTE PHARM HLC
MEDPOINTE PHARM HLC
BANNER PHARMACAPS
BANNER PHARMACAPS
ROXANE
TEVA
TEVA
AMNEAL PHARMS
INVAGEN PHARMS
PADDOCK LLC
ROXANE
ORGANON USA INC
ORGANON USA INC
CHIESI USA INC
CHIESI USA INC
LILLY
LILLY
PERNIX THERAP
CEPH INTL
CEPH INTL
CLONMEL HLTHCARE
CLONMEL HLTHCARE
HIKMA
HIKMA
RANBAXY
RANBAXY
TEVA
TEVA
TEVA
TEVA
WATSON LABS INC
WATSON LABS INC
YUNG SHIN PHARM
YUNG SHIN PHARM
AUROBINDO PHARMA
HIKMA
LUPIN
ORCHID HLTHCARE
PUREPAC PHARM
RANBAXY LABS LTD
SANDOZ
TEVA
TEVA PHARMS
AUROBINDO PHARMA
LUPIN
ORCHID HLTHCARE
SANDOZ
TEVA PHARMS
GD SEARLE
GD SEARLE
GD SEARLE
GD SEARLE
MYLAN PHARMS INC
TEVA
TEVA
TEVA
TEVA
ROCHE PALO
PARKE DAVIS
PARKE DAVIS
PARKE DAVIS
PARKE DAVIS
PARKE DAVIS
ALKEM LABS LTD
ALKEM LABS LTD
ALKEM LABS LTD
ALKEM LABS LTD
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
BARR
BARR
BELCHER PHARMS
BELCHER PHARMS
FACTA FARMA
FACTA FARMA
HIKMA
HIKMA
LUPIN
LUPIN
ORCHID HLTHCARE
ORCHID HLTHCARE
PUREPAC PHARM
PUREPAC PHARM
RANBAXY
RANBAXY
STEVENS J
STEVENS J
SUN PHARM INDS (IN)
SUN PHARM INDS (IN)
Strength
50MG
100MG
0.25MCG
0.5MCG
0.25MCG
0.25MCG
0.5MCG
EQ 169MG CALCIUM
EQ 169MG CALCIUM
EQ 169MG CALCIUM
EQ 169MG CALCIUM
0.02MG
0.05MG
20MG
30MG
EQ 250MG BASE
EQ 500MG BASE
EQ 400MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 500MG BASE
300MG
300MG
300MG
300MG
300MG
50MG
100MG
200MG
400MG
50MG
50MG
100MG
200MG
400MG
250MG
150MG
300MG
5MG
10MG
20MG
EQ 250MG BASE
EQ 333MG BASE
EQ 500MG BASE
EQ 750MG BASE
EQ 250MG BASE
EQ 250MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
Page 00038
Appl_Type
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
A
A
A
A
A
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
85381
3
85381
4
91174
1 AB
91174
2 AB
76917
1 AB
75765
1 AB
75765
2 AB
201658
1 AB
203135
1 AB
91312
1 AB
77728
1 AB
18312
1
18312
2
19488
1 AB
19488
2 AB
50521
1
50521
2
50685
2
62205
1
62205
2
64107
1
64107
2
65350
1 AB
65350
2 AB
64061
1
64061
2
64156
1
64156
2
64081
1
64145
1
64081
2
64145
2
64148
1
64148
2
65146
1 AB
65146
2 AB
65352
1 AB
65311
1 AB
62766
1
65392
1 AB
65309
1 AB
63017
1
65015
1
62291
1 AB
62695
1
65282
1 AB
65434
1 AB
65264
1 AB
65418
1 AB
65330
1 AB
65368
1 AB
20998
4 AB
20998
1 AB
20998
2 AB
20998
3 AB
78857
1 AB
76898
1 AB
76898
2 AB
76898
3 AB
76898
4 AB
50722
1 AB
10596
7
10596
8
18144
1
18144
2
18144
3
90836
1 AB
90836
3
90836
2 AB
90836
4 AB
62973
1
63063
1
63186
1
62974
1
63063
2
63186
2
65253
1 AB
65253
2 AB
62773
1
62775
1
62713
1 AB
62713
2 AB
62118
1
62118
2
65215
1 AB
65215
2 AB
61969
1
61969
2
65229
1 AB
65229
2 AB
65248
1 AB
65248
2 AB
62809
1
62809
2
65007
1 AB
65007
2 AB
62870
1
62869
1
62791
1 AB
62791
2 AB
Approval_Date
24‐May‐13
24‐May‐13
27‐Mar‐06
12‐Oct‐01
12‐Oct‐01
6‐Oct‐14
7‐Feb‐13
1‐Jun‐12
26‐Feb‐08
21‐Dec‐88
21‐Dec‐88
20‐Dec‐95
27‐Apr‐95
27‐Apr‐95
3‐Apr‐07
3‐Apr‐07
27‐Apr‐95
27‐Apr‐95
28‐Aug‐97
28‐Aug‐97
16‐Sep‐96
24‐Jun‐96
16‐Sep‐96
24‐Jun‐96
23‐May‐96
23‐May‐96
22‐Jan‐04
22‐Jan‐04
25‐Jan‐07
7‐Feb‐06
3‐Mar‐87
29‐May‐07
18‐Sep‐06
5‐Jan‐89
22‐Jun‐99
10‐Feb‐89
20‐Jan‐06
7‐Jan‐08
19‐May‐06
18‐Jul‐07
6‐Apr‐07
9‐May‐07
15‐Dec‐06
31‐Dec‐98
31‐Dec‐98
29‐Aug‐02
30‐May‐14
30‐May‐14
30‐May‐14
30‐May‐14
30‐May‐14
3‐May‐95
10‐May‐82
20‐Dec‐10
29‐Mar‐13
20‐Dec‐10
29‐Mar‐13
8‐Nov‐88
29‐Sep‐89
30‐Dec‐94
23‐Nov‐88
29‐Sep‐89
30‐Dec‐94
16‐Nov‐05
16‐Nov‐05
26‐Jun‐87
22‐Apr‐87
15‐Jul‐88
15‐Jul‐88
24‐Jan‐06
24‐Jan‐06
25‐Nov‐05
25‐Nov‐05
28‐Jun‐05
28‐Jun‐05
22‐Apr‐87
22‐Apr‐87
16‐Sep‐99
16‐Sep‐99
17‐Mar‐88
17‐Mar‐88
11‐Jun‐87
11‐Jun‐87
RLD
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
Yes
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
Yes
No
No
No
No
Yes
No
No
No
No
No
Yes
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Type
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
RX
RX
DISCN
DISCN
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
RX
RX
DISCN
DISCN
RX
RX
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
RX
RX
DISCN
DISCN
RX
RX
Applicant_Full_Name
INVAGEN PHARMACEUTICALS INC
ORGANON USA INC
ORGANON USA INC
CHIESI USA INC
CHIESI USA INC
ELI LILLY AND CO
ELI LILLY AND CO
PERNIX THERAPEUTICS LLC
CEPH INTERNATIONAL CORP
CEPH INTERNATIONAL CORP
CLONMEL HEALTHCARE LTD
YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD
LUPIN LTD
ORCHID HEALTHCARE
SANDOZ INC
LUPIN LTD
ORCHID HEALTHCARE
SANDOZ INC
GD SEARLE LLC
GD SEARLE LLC
GD SEARLE LLC
GD SEARLE LLC
ROCHE PALO ALTO LLC
ALKEM LABORATORIES LTD
APOTHECON INC DIV BRISTOL MYERS SQUIBB
AUROBINDO PHARMA LTD INC
BELCHER PHARMACEUTICALS LLC
BELCHER PHARMACEUTICALS LLC
FACTA FARMACEUTICI SPA
LUPIN LTD
LUPIN LTD
ORCHID HEALTHCARE
ORCHID HEALTHCARE
SUN PHARMACEUTICAL INDUSTRIES LTD
Page 00039
Ingredient
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHRADINE
CEPHRADINE
CEPHRADINE
CEPHRADINE
CEPHRADINE
CEPHRADINE
CEPHRADINE
CEPHRADINE
ELIGLUSTAT TARTRATE
NABILONE
CETIRIZINE HYDROCHLORIDE
CEVIMELINE HYDROCHLORIDE
SUCCIMER
CHLORAMPHENICOL
CHLORAMPHENICOL
CHLOROTRIANISENE
QUINIDINE SULFATE
QUINIDINE SULFATE
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00040
Trade_Name
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHRADINE
CEPHRADINE
CEPHRADINE
CEPHRADINE
CEPHRADINE
CEPHRADINE
CEPHRADINE
CEPHRADINE
CERDELGA
CESAMET
CETIRIZINE HYDROCHLORIDE ALLERGY
CETIRIZINE HYDROCHLORIDE ALLERGY
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
CEVIMELINE
CHEMET
CHLORDIAZACHEL
CHLORDIAZACHEL
CHLORDIAZACHEL
CHLOROMYCETIN
CHLOROMYCETIN
CHLOROTRIANISENE
CIN‐QUIN
CIN‐QUIN
Applicant
TEVA
TEVA
TEVA
TEVA
TEVA
TEVA
YOSHITOMI
YOSHITOMI
YUNG SHIN PHARM
YUNG SHIN PHARM
BARR
BARR
TEVA
TEVA
VITARINE
VITARINE
GENZYME CORP
MEDA PHARMS
BANNER PHARMACAPS
BANNER PHARMACAPS
BANNER PHARMACAPS
BANNER PHARMACAPS
APOTEX INC
PACK PHARMS LLC
ROXANE
RECORDATI RARE
RACHELLE
RACHELLE
RACHELLE
ASCOT
ASCOT
ASCOT
BARR
BARR
BARR
FERRANTE
FERRANTE
FERRANTE
HALSEY
HALSEY
HALSEY
HIKMA PHARMS LLC
HIKMA PHARMS LLC
HIKMA PHARMS LLC
IMPAX LABS
IMPAX LABS
IMPAX LABS
LEDERLE
LEDERLE
LEDERLE
LEDERLE
LEDERLE
LEDERLE
MAST MM
MYLAN
MYLAN
MYLAN
PARKE DAVIS
PARKE DAVIS
PARKE DAVIS
PIONEER PHARMS
PIONEER PHARMS
PUREPAC PHARM
PUREPAC PHARM
PUREPAC PHARM
ROXANE
ROXANE
ROXANE
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SUPERPHARM
SUPERPHARM
SUPERPHARM
TEVA
TEVA
TEVA
TEVA
USL PHARMA
USL PHARMA
USL PHARMA
VANGARD
VANGARD
VANGARD
WATSON LABS
WATSON LABS
WATSON LABS
PARKEDALE
PARKEDALE
BANNER PHARMACAPS
SOLVAY
SOLVAY
Strength
EQ 250MG BASE
EQ 250MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
EQ 84MG BASE
1MG
5MG
10MG
5MG
10MG
30MG
30MG
30MG
100MG
5MG
10MG
25MG
5MG
10MG
25MG
5MG
10MG
25MG
5MG
10MG
25MG
5MG
10MG
25MG
5MG
10MG
25MG
5MG
10MG
25MG
5MG
10MG
25MG
5MG
5MG
10MG
10MG
25MG
25MG
10MG
5MG
10MG
25MG
5MG
10MG
25MG
10MG
25MG
5MG
10MG
25MG
5MG
10MG
25MG
5MG
5MG
10MG
10MG
25MG
25MG
5MG
10MG
25MG
5MG
10MG
25MG
25MG
5MG
10MG
25MG
5MG
10MG
25MG
5MG
10MG
25MG
50MG
100MG
12MG
200MG
300MG
Page 00041
Appl_Type
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
A
A
A
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
62702
1 AB
62760
1
62821
1
62702
2 AB
62761
1
62823
1
62872
1
62871
1
65152
1 AB
65152
2 AB
62850
1
62851
1
62762
1
62762
2
62683
1
62683
2
62813
1
62813
2
205494
1
18677
1
22429
1
22429
4
22429
3
22429
2
91260
1 AB
203775
1 AB
91591
1 AB
19998
2
85086
1
84639
1
85087
1
87525
1
87524
1
87512
1
84768
1 AB
83116
1 AB
84769
1 AB
85118
1
85119
1
85120
1
85340
1
85339
1
84685
1
85014
1
85000
1
85294
1
86213
1
85113
1
86212
1
83741
1
83742
1
83570
1
86892
1
87234
1
86876
1
87037
1
86893
1
87231
1
86217
1
84886
1
84601
1
84887
1
85163
1
84598
1
85164
1
89533
1
89558
1
85155
1
84939
2
85144
1
84706
1
84700
1
84705
1
84678
1
84919
1
84041
1
84920
1
84679
2
84823
1
88987
1
88986
1
88988
1
88705
1
88706
1
86494
1
88707
1
84644
1
84623
1 AB
84645
1
88129
1
88010
1
88130
1
86383
1
86294
1
86382
1
60591
1
60591
3
84652
1
85296
1
85297
1
Approval_Date
13‐Feb‐87
24‐Apr‐87
5‐Feb‐88
13‐Feb‐87
24‐Apr‐87
5‐Feb‐88
20‐Jun‐88
5‐Jul‐88
24‐Feb‐05
24‐Feb‐05
22‐Apr‐88
22‐Apr‐88
6‐Mar‐87
6‐Mar‐87
9‐Jan‐87
9‐Jan‐87
25‐Feb‐88
25‐Feb‐88
19‐Aug‐14
26‐Dec‐85
23‐Jul‐09
23‐Jul‐09
23‐Jul‐09
23‐Jul‐09
25‐Aug‐11
4‐Jun‐14
8‐Jul‐13
30‐Jan‐91
7‐Jan‐82
7‐Jan‐82
7‐Jan‐82
15‐Jul‐88
15‐Jul‐88
25‐Apr‐85
25‐Apr‐85
25‐Apr‐85
18‐Jan‐85
18‐Jan‐85
18‐Jan‐85
28‐Mar‐83
28‐Mar‐83
28‐Mar‐83
RLD
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
Yes
No
Yes
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Type
RX
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
OTC
OTC
OTC
OTC
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
Applicant_Full_Name
YOSHITOMI PHARMACEUTICAL INDUSTRIES LTD
YOSHITOMI PHARMACEUTICAL INDUSTRIES LTD
GENZYME CORP
APOTEX INC
PACK PHARMACEUTICALS LLC
RECORDATI RARE DISEASES INC
RACHELLE LABORATORIES INC
ASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES INC
JOHN J FERRANTE
JOHN J FERRANTE
JOHN J FERRANTE
HALSEY DRUG CO INC
HALSEY DRUG CO INC
HALSEY DRUG CO INC
MM MAST AND CO
PIONEER PHARMACEUTICALS INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SUPERPHARM CORP
SUPERPHARM CORP
SUPERPHARM CORP
USL PHARMA INC
USL PHARMA INC
USL PHARMA INC
VANGARD LABORATORIES INC DIV MIDWAY MEDICAL CO
PARKEDALE PHARMACEUTICALS INC
SOLVAY PHARMACEUTICALS
Page 00042
Ingredient
RESCINNAMINE
CINOXACIN
CINOXACIN
CINOXACIN
CINOXACIN
CITALOPRAM HYDROBROMIDE
ISOTRETINOIN
ISOTRETINOIN
ISOTRETINOIN
ISOTRETINOIN
LORATADINE
CLINDAMYCIN HYDROCHLORIDE
CLOFIBRATE
CLOFIBRATE
CLOFIBRATE
CLOFIBRATE
CLOFIBRATE
CLORAZEPATE DIPOTASSIUM
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00043
Trade_Name
CINNASIL
CINOBAC
CINOBAC
CINOXACIN
CINOXACIN
CLARAVIS
CLARAVIS
CLARAVIS
CLARAVIS
CLARITIN
CLEOCIN
CLEOCIN
CLEOCIN HYDROCHLORIDE
CLOFIBRATE
CLOFIBRATE
CLOFIBRATE
CLOFIBRATE
CLOFIBRATE
Applicant
PANRAY
LILLY
LILLY
TEVA
TEVA
MYLAN PHARMS INC
MYLAN PHARMS INC
MYLAN PHARMS INC
TEVA PHARMS USA
TEVA PHARMS USA
TEVA PHARMS USA
TEVA PHARMS USA
SCHERING PLOUGH
AUROBINDO PHARMA
AUROBINDO PHARMA
COREPHARMA
COREPHARMA
LANNETT
LANNETT
LANNETT
MYLAN PHARMS INC
MYLAN PHARMS INC
MYLAN PHARMS INC
RANBAXY
RANBAXY
TEVA
TEVA
TEVA
WATSON LABS
WATSON LABS
WATSON LABS
ZYDUS PHARMS USA
ZYDUS PHARMS USA
ZYDUS PHARMS USA
BANNER PHARMACAPS
SANDOZ
TEVA
USL PHARMA
WATSON LABS
MYLAN
MYLAN
MYLAN
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
TARO
TARO
TARO
TEVA
TEVA
TEVA
TEVA
TEVA
TEVA
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
ABLE
ABLE
ABLE
AM THERAP
AM THERAP
AM THERAP
CLONMEL HLTHCARE
CLONMEL HLTHCARE
CLONMEL HLTHCARE
GD SEARLE LLC
GD SEARLE LLC
GD SEARLE LLC
MYLAN
MYLAN
MYLAN
PUREPAC PHARM
PUREPAC PHARM
PUREPAC PHARM
QUANTUM PHARMICS
QUANTUM PHARMICS
QUANTUM PHARMICS
SANDOZ
SANDOZ
SANDOZ
USL PHARMA
USL PHARMA
USL PHARMA
WARNER CHILCOTT
WARNER CHILCOTT
WARNER CHILCOTT
WATSON LABS
WATSON LABS
Strength
0.5MG
250MG
500MG
250MG
500MG
EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
10MG
20MG
30MG
40MG
10MG
EQ 75MG BASE
EQ 150MG BASE
EQ 75MG BASE
EQ 150MG BASE
EQ 300MG BASE
EQ 150MG BASE
EQ 300MG BASE
EQ 150MG BASE
EQ 300MG BASE
EQ 75MG BASE
EQ 150MG BASE
EQ 300MG BASE
EQ 75MG BASE
EQ 150MG BASE
EQ 300MG BASE
EQ 150MG BASE
EQ 300MG BASE
EQ 75MG BASE
EQ 150MG BASE
EQ 300MG BASE
EQ 75MG BASE
EQ 150MG BASE
EQ 300MG BASE
EQ 75MG BASE
EQ 150MG BASE
EQ 300MG BASE
500MG
500MG
500MG
500MG
500MG
25MG
50MG
75MG
25MG
25MG
50MG
50MG
75MG
75MG
25MG
50MG
75MG
25MG
25MG
50MG
50MG
75MG
75MG
25MG
25MG
50MG
50MG
75MG
75MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
15MG
3.75MG
7.5MG
Page 00044
Appl_Type
A
N
N
A
A
A
A
A
A
A
A
A
N
A
A
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
84736
1
18067
1
18067
2
73005
1
73006
1
77668
1
77668
2
77668
3
76356
1 AB
76135
2 AB
76135
3 AB
76135
1 AB
21952
1
61809
1
61809
2
50162
1 AB
50162
2 AB
50162
3 AB
65442
1 AB
65442
2 AB
65194
1 AB
65194
2 AB
65242
1 AB
65242
2 AB
65243
1 AB
91225
1 AB
91225
2 AB
91225
3 AB
65061
1 AB
65061
2 AB
63027
1
63029
1 AB
63029
2 AB
63082
1
63083
1 AB
63083
2 AB
65217
1 AB
65217
2 AB
65217
3 AB
73396
1
72191
1
72600
1
70531
1
71603
1
74947
1 AB
74947
2 AB
74947
3 AB
74364
1 AB
74953
1
74364
2 AB
74953
2
74364
3 AB
74953
3
74694
1 AB
74694
2 AB
74694
3 AB
74849
1
74958
1 AB
74849
2
74958
2 AB
74849
3
74958
3 AB
74600
1
74751
1
74600
2
74751
2
74600
3
74751
3
71777
1
71778
1
71779
1
71429
1
71430
1
71431
1
71742
1
71743
1
71744
1
71727
1
71728
1
71729
1
71509
1
71510
1
71511
1
71924
1
71925
1
71926
1
71549
1
71550
1
71522
1
72219
1
72220
1
72112
1
71242
1
71243
1
71244
1
71774
1
71775
1
71776
1
71878
1
71879
1
Approval_Date
28‐Feb‐92
28‐Feb‐92
28‐Feb‐07
28‐Feb‐07
28‐Feb‐07
11‐Apr‐03
11‐Apr‐03
11‐May‐06
11‐Apr‐03
16‐Jun‐08
14‐Apr‐88
26‐Aug‐09
26‐Aug‐09
22‐Mar‐04
22‐Mar‐04
12‐Aug‐05
12‐Aug‐05
12‐Aug‐05
31‐May‐11
31‐May‐11
31‐May‐11
2‐Feb‐01
2‐Feb‐01
20‐Sep‐89
20‐Sep‐89
5‐Aug‐05
31‐Jul‐91
31‐Jul‐91
18‐Mar‐03
31‐Jan‐05
31‐Jan‐05
31‐Jan‐05
20‐Mar‐92
2‐May‐88
25‐Jul‐91
16‐Jun‐86
18‐Sep‐87
30‐Apr‐98
30‐Apr‐98
30‐Apr‐98
29‐Mar‐96
25‐Jun‐97
29‐Mar‐96
25‐Jun‐97
29‐Mar‐96
25‐Jun‐97
31‐Dec‐96
31‐Dec‐96
31‐Dec‐96
4‐Apr‐97
26‐Aug‐97
4‐Apr‐97
26‐Aug‐97
4‐Apr‐97
26‐Aug‐97
27‐Nov‐96
30‐Sep‐98
27‐Nov‐96
30‐Sep‐98
27‐Nov‐96
30‐Sep‐98
14‐Jul‐87
14‐Jul‐87
14‐Jul‐87
23‐Jun‐87
23‐Jun‐87
23‐Jun‐87
14‐Dec‐87
14‐Dec‐87
14‐Dec‐87
18‐Dec‐87
18‐Dec‐87
18‐Dec‐87
19‐Oct‐87
19‐Oct‐87
19‐Oct‐87
25‐Apr‐88
25‐Apr‐88
25‐Apr‐88
12‐Sep‐88
12‐Sep‐88
12‐Sep‐88
26‐Aug‐88
26‐Aug‐88
26‐Aug‐88
23‐Jun‐87
23‐Jun‐87
23‐Jun‐87
1‐Mar‐88
1‐Mar‐88
1‐Mar‐88
15‐Mar‐88
15‐Mar‐88
RLD
No
No
No
No
No
No
No
Yes
No
No
No
Yes
Yes
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Type
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
OTC
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
RX
DISCN
RX
DISCN
RX
RX
RX
DISCN
RX
DISCN
RX
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
Applicant_Full_Name
PANRAY CORP SUB ORMONT DRUG AND CHEMICAL CO INC
ELI LILLY AND CO
ELI LILLY AND CO
SCHERING PLOUGH HEALTHCARE PRODUCTS INC
COREPHARMA LLC
COREPHARMA LLC
SANDOZ INC
USL PHARMA INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
AMERICAN THERAPEUTICS INC
GD SEARLE LLC
GD SEARLE LLC
GD SEARLE LLC
SANDOZ INC
SANDOZ INC
SANDOZ INC
USL PHARMA INC
USL PHARMA INC
USL PHARMA INC
WARNER CHILCOTT DIV WARNER LAMBERT CO
Page 00045
Ingredient
CLOXACILLIN SODIUM
CLOXACILLIN SODIUM
CLOXACILLIN SODIUM
CLOXACILLIN SODIUM
CLOXACILLIN SODIUM
CLOXACILLIN SODIUM
CLOXACILLIN SODIUM
CLOXACILLIN SODIUM
TACRINE HYDROCHLORIDE
CABOZANTINIB S‐MALATE
CABOZANTINIB S‐MALATE
ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE
INDINAVIR SULFATE
INDINAVIR SULFATE
INDINAVIR SULFATE
INDINAVIR SULFATE
PENICILLAMINE
PENICILLAMINE
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
CYCLOSPORINE
CYCLOSPORINE
CYCLOSPORINE
CYCLOSPORINE
CYCLOSPORINE
CYCLOSPORINE
CYCLOSPORINE
CYCLOSPORINE
CYCLOSPORINE
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
GANCICLOVIR
CAPSULE;ORAL
GANCICLOVIR
FLURAZEPAM HYDROCHLORIDE
DANAZOL
DANAZOL
DANAZOL
DANAZOL
DANAZOL
DANAZOL
DANAZOL
DANAZOL
DANAZOL
DANAZOL
DANTROLENE SODIUM
DANTROLENE SODIUM
DANTROLENE SODIUM
DANTROLENE SODIUM
DANTROLENE SODIUM
DANTROLENE SODIUM
DANTROLENE SODIUM
DANTROLENE SODIUM
DANTROLENE SODIUM
PROPOXYPHENE HYDROCHLORIDE
ASPIRIN; PROPOXYPHENE HYDROCHLORIDE
ASPIRIN; PROPOXYPHENE NAPSYLATE
DEMECLOCYCLINE HYDROCHLORIDE
VITAMIN A PALMITATE
AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE
ERGOCALCIFEROL
METYROSINE
VALPROIC ACID
PHENOXYBENZAMINE HYDROCHLORIDE
DICLOXACILLIN SODIUM
DICUMAROL
DICUMAROL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00046
Trade_Name
CLOXACILLIN SODIUM
CLOXACILLIN SODIUM
CLOXACILLIN SODIUM
CLOXACILLIN SODIUM
CLOXAPEN
CLOXAPEN
CLOXAPEN
CLOXAPEN
CO‐GESIC
CODEINE, ASPIRIN, APAP FORMULA NO. 2
COGNEX
COGNEX
COGNEX
COGNEX
COLAZAL
COMETRIQ
COMETRIQ
COMPOUND 65
COTAZYM
CRIXIVAN
CRIXIVAN
CRIXIVAN
CRIXIVAN
CUPRIMINE
CUPRIMINE
CYCLOPAR
CYCLOPAR
CYCLOPAR
CYCLOPAR
CYCLOPAR
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
CYCLOSPORINE
CYCLOSPORINE
CYCLOSPORINE
CYCLOSPORINE
CYCLOSPORINE
CYCLOSPORINE
CYCLOSPORINE
CYCLOSPORINE
CYCLOSPORINE
CYSTAGON
CYSTAGON
Applicant
WATSON LABS
APOTHECON
APOTHECON
TEVA
TEVA
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
CENT PHARMS
SCHERER LABS
SCHERER LABS
SCHERER LABS
SHIONOGI INC
SHIONOGI INC
SHIONOGI INC
SHIONOGI INC
SALIX PHARMS
EXELIXIS
EXELIXIS
ALRA
ORGANON USA INC
MERCK SHARP DOHME
MERCK SHARP DOHME
MERCK SHARP DOHME
MERCK SHARP DOHME
ATON
ATON
WARNER CHILCOTT
WARNER CHILCOTT
WARNER CHILCOTT
WARNER CHILCOTT
WARNER CHILCOTT
ROXANE
ROXANE
APOTEX
APOTEX
SANDOZ
SANDOZ
WATSON LABS INC
WATSON LABS INC
MYLAN
MYLAN
CYTOVENE
ROCHE PALO
CYTOVENE
DALMANE
DALMANE
DANAZOL
DANAZOL
DANAZOL
DANAZOL
DANAZOL
DANAZOL
DANAZOL
DANOCRINE
DANOCRINE
DANOCRINE
DANTRIUM
DANTRIUM
DANTRIUM
DANTROLENE SODIUM
DANTROLENE SODIUM
DANTROLENE SODIUM
DANTROLENE SODIUM
DANTROLENE SODIUM
DANTROLENE SODIUM
DARVON
DARVON
DARVON COMPOUND
DARVON COMPOUND‐65
DARVON W/ ASA
DARVON‐N W/ ASA
DECLOMYCIN
DEL‐VI‐A
ROCHE PALO
VALEANT PHARM INTL
VALEANT PHARM INTL
AM THERAP
BARR
BARR
BARR
LANNETT
LANNETT
LANNETT
SANOFI AVENTIS US
SANOFI AVENTIS US
SANOFI AVENTIS US
PAR STERILE PRODUCTS
IMPAX LABS
IMPAX LABS
IMPAX LABS
MIKAH PHARMA
MIKAH PHARMA
MIKAH PHARMA
XANODYNE PHARM
XANODYNE PHARM
XANODYNE PHARM
XANODYNE PHARM
XANODYNE PHARM
AAIPHARMA LLC
LEDERLE
DEL RAY LABS
DELCOBESE
TEVA
DELCOBESE
TEVA
DELCOBESE
TEVA
DELCOBESE
DELTALIN
DEMSER
DEPAKENE
DEXAMPEX
DHC PLUS
DIBENZYLINE
DICUMAROL
DICUMAROL
TEVA
LILLY
ATON PHARMA VPNA
ABBVIE
TEVA
PHARM RES ASSOC
WELLSPRING PHARM
SANDOZ
SANDOZ
SANDOZ
TEVA
TEVA
LILLY
LILLY
Strength
15MG
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 500MG BASE
500MG;5MG
150MG;180MG;15MG
150MG;180MG;30MG
150MG;180MG;60MG
EQ 10MG BASE
EQ 20MG BASE
EQ 30MG BASE
EQ 40MG BASE
750MG
EQ 20MG BASE
EQ 80MG BASE
389MG;32.4MG;65MG
EQ 100MG BASE
EQ 200MG BASE
EQ 333MG BASE
EQ 400MG BASE
125MG
250MG
250MG
250MG
250MG
500MG
500MG
25MG
50MG
25MG
100MG
25MG
50MG
100MG
25MG
100MG
25MG
100MG
EQ 50MG BASE
EQ 150MG BASE
15MG
30MG
200MG
50MG
100MG
200MG
50MG
100MG
200MG
50MG
100MG
200MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
32MG
65MG
389MG;32.4MG;32MG
389MG;32.4MG;65MG
325MG;65MG
325MG;100MG
150MG
1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
50,000 IU
250MG
250MG
15MG
356.4MG;30MG;16MG
10MG
EQ 125MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
25MG
50MG
Page 00047
Appl_Type
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
A
N
N
N
N
N
N
N
A
A
A
A
A
N
N
A
A
A
A
A
A
A
A
A
N
N
71860
1
61452
1
61452
2
62240
1
62240
2
61806
1
62233
1
61806
2
62233
2
89360
1
85640
1
85639
1
85638
1
20070
1
20070
2
20070
3
20070
4
20610
1 AB
203756
1
203756
2
84553
2
20580
1
20685
6
20685
3
20685
5
20685
1
19853
2
19853
1
61725
1
62175
1
62332
1
61725
2
62332
2
203856
1
203856
2
65040
1 AB2
65040
2 AB2
65110
3 AB1
65110
1 AB1
65110
2 AB1
65017
2 AB1
65017
1 AB1
65044
2 AB1
65044
1 AB1
20392
1
20392
2
N
20460
1
N
N
N
A
A
A
A
A
A
A
N
N
N
N
N
N
A
A
A
A
A
A
N
N
N
N
N
N
N
A
20460
16721
16721
71569
74582
74582
74582
78214
78214
77246
17557
17557
17557
17443
17443
17443
76856
76856
76856
76686
76686
76686
10997
10997
10996
10996
10996
16829
50262
80830
2
1
2
1
3
2
1
1
2
1
3
4
2
1
3
2
1
2
3
1
2
3
1
3
6
7
5
1
1
1
A
83564
A
A
A
A
N
N
A
A
N
A
A
A
A
A
N
N
Approval_Date
15‐Mar‐88
2‐Mar‐88
9‐Sep‐93
9‐Sep‐93
9‐Sep‐93
9‐Sep‐93
18‐Jul‐00
29‐Nov‐12
29‐Nov‐12
17‐Aug‐83
9‐Dec‐96
19‐Apr‐00
13‐Mar‐96
17‐Dec‐98
13‐Mar‐96
16‐Sep‐13
16‐Sep‐13
9‐May‐02
9‐May‐02
29‐Mar‐05
29‐Mar‐05
29‐Mar‐05
13‐Jan‐00
13‐Jan‐00
20‐Dec‐00
20‐Dec‐00
15‐Aug‐94
15‐Aug‐94
RLD
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
Yes
No
No
No
No
No
Yes
No
Yes
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
Yes
22‐Dec‐94 No
Type
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
RX
DISCN
RX
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
Applicant_Full_Name
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
SCHERER LABORATORIES INC
SHIONOGI INC
SHIONOGI INC
SHIONOGI INC
SHIONOGI INC
EXELIXIS INC
EXELIXIS INC
ALRA LABORATORIES INC
ORGANON USA INC
ATON PHARMA INC
ATON PHARMA INC
APOTEX INC
APOTEX INC
SANDOZ INC
SANDOZ INC
DISCN ROCHE PALO ALTO LLC
12‐Dec‐97
30‐Dec‐87
29‐May‐98
29‐May‐98
9‐Aug‐96
19‐Apr‐07
19‐Apr‐07
28‐Sep‐05
1‐Mar‐05
1‐Mar‐05
1‐Mar‐05
24‐Oct‐05
24‐Oct‐05
24‐Oct‐05
8‐Mar‐83
8‐Mar‐83
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
1
No
DISCN TEVA PHARMACEUTICALS USA INC
83564
2
No
83564
3
No
83564
80884
17871
18081
85355
88584
8708
61454
61454
61454
62286
62286
5509
5509
4
1
1
1
1
1
1
2
1
3
1
2
3
1
4‐Mar‐86
3‐Jun‐82
3‐Jun‐82
No
No
Yes
Yes
No
No
Yes
No
No
Yes
No
No
No
No
DISCN
DISCN
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
DISCN
DISCN
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
ROCHE PALO ALTO LLC
PAR STERILE PRODUCTS LLC
MIKAH PHARMA LLC
MIKAH PHARMA LLC
MIKAH PHARMA LLC
XANODYNE PHARMACEUTICS INC
AAIPHARMA LLC
DEL RAY LABORATORIES INC
ELI LILLY AND CO
ATON PHARMA DIV VALEANT PHARMACEUTICALS NORTH AMERICA LLC
ABBVIE INC
PHARMACEUTICAL RESEARCH ASSOC INC
WELLSPRING PHARMACEUTICAL CORP
SANDOZ INC
SANDOZ INC
SANDOZ INC
ELI LILLY AND CO
ELI LILLY AND CO
Page 00048
Ingredient
PHENYTOIN SODIUM
PHENYTOIN SODIUM
VALSARTAN
VALSARTAN
OLSALAZINE SODIUM
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
PHENYTOIN SODIUM
PHENYTOIN SODIUM
LEVODOPA
LEVODOPA
LEVODOPA
GLUTETHIMIDE
DOXEPIN HYDROCHLORIDE
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00049
Trade_Name
DILANTIN
DILANTIN
DIOVAN
DIOVAN
DIPENTUM
DIPHENOXYLATE HYDROCHLORIDE W/ ATROPINE SULFATE
DIPHENYLAN SODIUM
DIPHENYLAN SODIUM
DOLENE
DOPAR
DOPAR
DOPAR
DORIDEN
Applicant
HIKMA PHARMS LLC
LANNETT
MUTUAL PHARM
MYLAN
PIONEER PHARMS
WATSON LABS
WATSON LABS
PARKE DAVIS
PARKE DAVIS
NOVARTIS
NOVARTIS
MEDA PHARMS
ALRA
ALRA
ANABOLIC
BARR
ELKINS SINN
ELKINS SINN
HALSEY
HEATHER
HEATHER
HIKMA PHARMS LLC
IMPAX LABS
IMPAX LABS
LANNETT
LANNETT
LEDERLE
LEDERLE
LNK
LNK
MK LABS
MK LABS
MUTUAL PHARM
MUTUAL PHARM
MUTUAL PHARM
NEWTRON PHARMS
NEWTRON PHARMS
NEXGEN PHARMA INC
PERRIGO
PERRIGO
PIONEER PHARMS
PIONEER PHARMS
PUREPAC PHARM
PUREPAC PHARM
PVT FORM
PVT FORM
ROXANE
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SUPERPHARM
SUPERPHARM
TEVA
TEVA
VALEANT PHARM INTL
VALEANT PHARM INTL
VANGARD
VANGARD
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WHITEWORTH TOWN PLSN
SCHERER RP
LANNETT
LANNETT
INTERPHARM
INTERPHARM
MUTUAL PHARM
MUTUAL PHARM
MYLAN
MYLAN
SANDOZ
SANDOZ
SUPERPHARM
SUPERPHARM
TEVA
TEVA
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
HERITAGE PHARMS INC
SHIRE
SHIRE
SHIRE
SANOFI AVENTIS US
DAVA PHARMS INC
DAVA PHARMS INC
DAVA PHARMS INC
DAVA PHARMS INC
DAVA PHARMS INC
Strength
10MG
10MG
10MG
10MG
10MG
10MG
10MG
30MG EXTENDED
100MG EXTENDED
80MG
160MG
250MG
25MG
50MG
50MG
50MG
25MG
50MG
50MG
25MG
50MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
25MG
50MG
25MG
50MG
25MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
50MG
25MG
25MG
50MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
25MG
25MG
50MG
50MG
50MG
25MG
50MG
0.025MG;2.5MG
30MG PROMPT
100MG PROMPT
EQ 100MG BASE
EQ 150MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 100MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 150MG BASE
65MG
100MG
250MG
500MG
500MG
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
Page 00050
Appl_Type
A
A
A
A
A
A
A
A
A
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
A
A
A
A
A
40204
1
84285
1 AB
84505
1
40319
1 AB
89361
1
83179
1
85082
1 AB
84349
1 AB
84349
2 AB
20665
1
20665
2
19715
1
80519
4
80519
3
83275
1
80738
1
85701
1
85701
2
87914
1
84524
1
83953
1
83567
1
80807
1
80807
2
80762
1
80762
2
80868
1
80868
2
86874
1
86875
1
87977
1
87978
1
83087
1
83087
2
84506
1
89488
1
89489
1
86543
1
86544
1
83634
1
83061
1
83061
2
89101
1
88880
1
85156
1
85150
1
83027
1
83027
2
80635
1
80832
1
80845
2
80832
2
80845
1
89040
1
89041
1
85874
1
85874
2
80596
1
80592
1
88034
1
87630
1
80728
1
83797
1
85138
1
80727
1
83797
2
85083
1
83441
1
80800
1
86440
1
80857
1
80857
2
71190
1
71191
1
70186
1
70187
1
70351
1
70352
1
70138
1
70139
1
70470
1
70471
1
70940
1
70941
1
70101
1 AB
70102
1 AB
70173
1 AB
70240
1
70174
1 AB
70241
1
80530
1
16913
3
16913
1
16913
2
9519
8
71685
1
71686
1
71673
1
71674
1
71675
1
Approval_Date
28‐Feb‐97
21‐Oct‐86
7‐Sep‐99
10‐Jan‐89
12‐Feb‐86
19‐Jun‐86
23‐Dec‐96
23‐Dec‐96
31‐Jul‐90
4‐Jun‐84
27‐Jan‐83
27‐Jan‐83
2‐Jan‐87
2‐Jan‐87
20‐Dec‐85
20‐Dec‐85
15‐May‐85
15‐May‐85
27‐Oct‐82
15‐Jan‐87
15‐Jan‐87
18‐Nov‐85
18‐Nov‐85
17‐Dec‐85
17‐Dec‐85
14‐Jun‐85
14‐Jun‐85
10‐Dec‐85
10‐Dec‐85
9‐Feb‐87
9‐Feb‐87
22‐Feb‐85
22‐Feb‐85
31‐May‐85
2‐Feb‐86
31‐May‐85
2‐Feb‐86
5‐Jan‐88
5‐Jan‐88
5‐Jan‐88
5‐Jan‐88
5‐Jan‐88
RLD
No
No
No
No
No
No
No
Yes
Yes
No
No
Yes
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Type
DISCN
RX
DISCN
RX
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
RX
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
Applicant_Full_Name
LANNETT CO INC
ANABOLIC INC
ELKINS SINN DIV AH ROBINS CO INC
HALSEY DRUG CO INC
HEATHER DRUG CO INC
HEATHER DRUG CO INC
LANNETT CO INC
LANNETT CO INC
LNK INTERNATIONAL INC
LNK INTERNATIONAL INC
MK LABORATORIES INC
MK LABORATORIES INC
NEWTRON PHARMACEUTICALS INC
NEWTRON PHARMACEUTICALS INC
NEXGEN PHARMA INC
L PERRIGO CO
L PERRIGO CO
PRIVATE FORMULATIONS INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SUPERPHARM CORP
SUPERPHARM CORP
WHITEWORTH TOWNE PAULSEN INC
LANNETT CO INC
LANNETT CO INC
INTERPHARM INC
INTERPHARM INC
SANDOZ INC
SANDOZ INC
SUPERPHARM CORP
SUPERPHARM CORP
Page 00051
Ingredient
DOXERCALCIFEROL
DOXERCALCIFEROL
DOXERCALCIFEROL
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00052
Trade_Name
DOXERCALCIFEROL
DOXERCALCIFEROL
DOXERCALCIFEROL
DOXY‐LEMMON
DOXY‐LEMMON
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
Applicant
DAVA PHARMS INC
MUTUAL PHARM
MUTUAL PHARM
MUTUAL PHARM
MUTUAL PHARM
MYLAN PHARMS INC
MYLAN PHARMS INC
MYLAN PHARMS INC
MYLAN PHARMS INC
MYLAN PHARMS INC
NEW RIVER
NEW RIVER
NEW RIVER
NEW RIVER
NEW RIVER
NEW RIVER
PAR PHARM
PAR PHARM
PAR PHARM
PAR PHARM
PAR PHARM
PAR PHARM
PUREPAC PHARM
PUREPAC PHARM
PUREPAC PHARM
PUREPAC PHARM
PUREPAC PHARM
PUREPAC PHARM
QUANTUM PHARMICS
QUANTUM PHARMICS
QUANTUM PHARMICS
QUANTUM PHARMICS
QUANTUM PHARMICS
QUANTUM PHARMICS
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
ROXANE
ROXANE
ROXANE
TEVA
TEVA
IMPAX LABS INC
LUPIN LTD
LUPIN LTD
LUPIN LTD
MYLAN PHARMS INC
PAR PHARM
PAR PHARM
PAR PHARM
PAR PHARM
RANBAXY
RANBAXY
RANBAXY
SANDOZ INC
SANDOZ INC
WATSON LABS
WATSON LABS
ACTAVIS LABS FL INC
ACTAVIS LABS FL INC
CHARTWELL LIFE SCI
CHARTWELL LIFE SCI
HALSEY
HALSEY
HEATHER
HEATHER
HIKMA INTL PHARMS
HIKMA INTL PHARMS
HIKMA INTL PHARMS
INTERPHARM
INTERPHARM
MUTUAL PHARM
MUTUAL PHARM
MUTUAL PHARM
MUTUAL PHARM
MYLAN
MYLAN
PAR PHARM
PAR PHARM
PVT FORM
PVT FORM
RANBAXY
RANBAXY
SUPERPHARM
Strength
EQ 150MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 10MG BASE
EQ 10MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 25MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 50MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 100MG BASE
EQ 150MG BASE
0.5MCG
1MCG
2.5MCG
EQ 50MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 150MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 20MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
Page 00053
Appl_Type
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
71676
1
71502
1
71653
1
71654
1
71521
1
70791
2 AB
70791
3 AB
70791
1 AB
70791
4 AB
70791
5 AB
16987
1
16987
2
16987
3
16987
6
16987
4
16987
7
71697
1
71437
1
71595
1
71608
1
71422
1
71669
1
73054
1
72109
1
73055
1
72386
1
72110
1
72387
1
70972
1
70973
1
70931
1
70932
1
72375
1
72376
1
71487
1
70827
1
70828
1
70825
1
71562
1
70952
1
71485
1
72985
1
70953
1
71486
1
72986
1
70954
1
71238
1
72987
1
71326
1
71763
1
70955
1
71239
1
71764
1
91433
1 AB
91433
2 AB
91433
3 AB
62497
1
62497
2
200065
1 AB
204234
1 AB
204234
2 AB
204234
3 AB
202778
1 AB
65055
1 AB
65055
4
65055
2 AB
65055
3 AB
65053
1 AB
65053
3 AB
65053
2 AB
65032
1
65032
2
65041
1
65041
2
62031
2 AB
62031
1 AB
62500
1 AB
62500
2 AB
62119
2
62119
1
62463
1
62463
2
65103
1
62396
2 AB
62396
1 AB
62763
1
62763
2
62418
1
62675
1 AB
62418
2
62676
1 AB
62337
1 AB
62337
2 AB
62434
1
62442
1
62631
1
62631
2
62479
1
62479
2
62469
1
Approval_Date
5‐Jan‐88
18‐Feb‐88
18‐Feb‐88
18‐Feb‐88
18‐Feb‐88
13‐May‐86
13‐May‐86
13‐May‐86
13‐May‐86
13‐May‐86
13‐Apr‐87
9‐Nov‐87
9‐Nov‐87
9‐Nov‐87
9‐Nov‐87
9‐Nov‐87
9‐Nov‐87
28‐Dec‐90
28‐Dec‐90
28‐Dec‐90
8‐Sep‐88
8‐Sep‐88
8‐Sep‐88
29‐Sep‐87
29‐Sep‐87
29‐Sep‐87
29‐Sep‐87
15‐Mar‐89
15‐Mar‐89
2‐Mar‐87
15‐May‐86
15‐May‐86
15‐May‐86
2‐Mar‐87
4‐Mar‐87
30‐Apr‐87
29‐Mar‐91
15‐May‐86
30‐Apr‐87
29‐Mar‐91
15‐May‐86
30‐Apr‐87
29‐Mar‐91
30‐Apr‐87
9‐Feb‐88
15‐May‐86
30‐Apr‐87
9‐Feb‐88
23‐Sep‐11
14‐Jan‐14
14‐Jan‐14
23‐Aug‐84
15‐Jun‐84
17‐Feb‐11
5‐Mar‐14
5‐Mar‐14
5‐Mar‐14
8‐Jun‐12
1‐Dec‐00
18‐Apr‐05
1‐Dec‐00
15‐Jul‐05
22‐Nov‐00
10‐Sep‐03
22‐Nov‐00
30‐Jun‐00
30‐Jun‐00
28‐Apr‐00
28‐Apr‐00
13‐Oct‐82
11‐Sep‐84
11‐Sep‐84
24‐May‐85
24‐May‐85
7‐Dec‐83
7‐Dec‐83
13‐May‐05
7‐Nov‐84
7‐May‐84
2‐Sep‐88
2‐Sep‐88
28‐Jan‐83
10‐Jul‐86
28‐Jan‐83
10‐Jul‐86
29‐Mar‐82
29‐Mar‐82
19‐Oct‐84
22‐Dec‐83
24‐Jul‐86
24‐Jul‐86
23‐Dec‐83
23‐Dec‐83
31‐Oct‐84
RLD
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Type
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
RX
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
Applicant_Full_Name
NEW RIVER PHARMACEUTICALS INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
LUPIN LTD
LUPIN LTD
LUPIN LTD
SANDOZ INC
SANDOZ INC
CHARTWELL LIFE SCIENCE LLC
HALSEY DRUG CO INC
HALSEY DRUG CO INC
HEATHER DRUG CO INC
HEATHER DRUG CO INC
INTERPHARM INC
INTERPHARM INC
SUPERPHARM CORP
Page 00054
Ingredient
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
ERGOCALCIFEROL
DRONABINOL
DRONABINOL
DRONABINOL
DRONABINOL
DRONABINOL
DRONABINOL
DRONABINOL
DRONABINOL
DRONABINOL
HYDROXYUREA
HYDROXYUREA
HYDROXYUREA
DUTASTERIDE
DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
HYDROCHLOROTHIAZIDE; TRIAMTERENE
ISRADIPINE
ISRADIPINE
TRIAMTERENE
TRIAMTERENE
SELEGILINE HYDROCHLORIDE
THEOPHYLLINE
THEOPHYLLINE
PENTOSAN POLYSULFATE SODIUM
ESTRAMUSTINE PHOSPHATE SODIUM
APREPITANT
APREPITANT
APREPITANT
EMTRICITABINE
ALVIMOPAN
BUDESONIDE
OMEGA‐3‐CARBOXYLIC ACIDS
MEPROBAMATE
ERGOCALCIFEROL
ERGOCALCIFEROL
ERGOCALCIFEROL
ERGOCALCIFEROL
VISMODEGIB
ERYTHROMYCIN ESTOLATE
ESCITALOPRAM OXALATE
LITHIUM CARBONATE
ETHCHLORVYNOL
ETHCHLORVYNOL
ETHCHLORVYNOL
ETHCHLORVYNOL
ETHOSUXIMIDE
ETHOSUXIMIDE
ETHOSUXIMIDE
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETOPOSIDE
FLUTAMIDE
RIVASTIGMINE TARTRATE
PHENYTOIN SODIUM
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00055
Trade_Name
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DRISDOL
DRONABINOL
DRONABINOL
DRONABINOL
DRONABINOL
DRONABINOL
DRONABINOL
DRONABINOL
DRONABINOL
DRONABINOL
DROXIA
DROXIA
DROXIA
DURICEF
DURICEF
DUTASTERIDE
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
DYAZIDE
DYAZIDE
DYCILL
DYCILL
DYCILL
DYCILL
DYNACIN
DYNACIN
DYNACIN
DYNACIRC
DYNACIRC
DYRENIUM
DYRENIUM
ELDEPRYL
ELIXOPHYLLIN
ELIXOPHYLLIN
ELMIRON
EMCYT
EMEND
EMEND
EMEND
EMTRIVA
ENTEREG
ENTOCORT EC
EPANOVA
EQUANIL
ERGOCALCIFEROL
ERGOCALCIFEROL
ERGOCALCIFEROL
ERGOCALCIFEROL
ERIVEDGE
ESGIC‐PLUS
ESKALITH
ETHCHLORVYNOL
ETHCHLORVYNOL
ETHCHLORVYNOL
ETHCHLORVYNOL
ETHOSUXIMIDE
ETHOSUXIMIDE
ETHOSUXIMIDE
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETODOLAC
ETOPOSIDE
EULEXIN
EVOXAC
EXELON
EXELON
EXELON
EXELON
EXTENDED PHENYTOIN SODIUM
Applicant
SUPERPHARM
WARNER CHILCOTT
WARNER CHILCOTT
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
SANOFI AVENTIS US
AKORN INC
AKORN INC
AKORN INC
INSYS THERAP
INSYS THERAP
INSYS THERAP
SVC PHARMA
SVC PHARMA
SVC PHARMA
WARNER CHILCOTT
WARNER CHILCOTT
BARR
ANCHEN PHARMS
GLAXOSMITHKLINE LLC
GLAXOSMITHKLINE LLC
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
CNTY LINE PHARMS
CNTY LINE PHARMS
CNTY LINE PHARMS
SMITHKLINE BEECHAM
SMITHKLINE BEECHAM
COVIS PHARMA SARL
COVIS PHARMA SARL
SOMERSET
FOREST LABS
FOREST LABS
JANSSEN PHARMS
MERCK
MERCK
MERCK
GILEAD
CUBIST PHARMS
ASTRAZENECA
ASTRAZENECA PHARMS
WYETH AYERST
ORIT LABS LLC
SIGMAPHARM LABS LLC
STRIDES PHARMA
SUN PHARM INDS INC
GENENTECH
BARR
BARR
WATSON LABS
MYLAN PHARMS INC
MYLAN PHARMS INC
MYLAN PHARMS INC
MIKART
NOVEN THERAP
BANNER PHARMACAPS
BANNER PHARMACAPS
BANNER PHARMACAPS
BANNER PHARMACAPS
BANNER PHARMACAPS
VERSAPHARM
AAIPHARMA LLC
ANI PHARMS INC
ANI PHARMS INC
ANI PHARMS INC
ANI PHARMS INC
APOTEX
APOTEX
MYLAN
MYLAN
MYLAN
MYLAN
SANDOZ
SANDOZ
SANDOZ
SANDOZ
TARO
TARO
VINTAGE PHARMS LLC
VINTAGE PHARMS LLC
WATSON LABS
WATSON LABS
MYLAN
SCHERING
DAIICHI SANKYO
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS
AMNEAL PHARMS NY
Strength
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 100MG BASE
50,000 IU
2.5MG
5MG
10MG
2.5MG
5MG
10MG
2.5MG
5MG
10MG
200MG
300MG
400MG
EQ 250MG BASE
EQ 500MG BASE
0.5MG
0.5MG;0.4MG
25MG;37.5MG
25MG;50MG
EQ 250MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
2.5MG
5MG
50MG
100MG
5MG
100MG
200MG
100MG
EQ 140MG PHOSPHATE
40MG
80MG
125MG
200MG
12MG
3MG
1GM CONTAINS AT LEAST 850MG OF POLYUNSATURATED FATTY ACIDS
400MG
50,000 IU
50,000 IU
50,000 IU
50,000 IU
150MG
EQ 125MG BASE
EQ 250MG BASE
EQ 250MG BASE
EQ 250MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 20MG BASE
500MG;50MG;40MG
300MG
100MG
200MG
500MG
750MG
250MG
250MG
250MG
300MG
200MG
200MG
300MG
300MG
200MG
300MG
200MG
200MG
300MG
300MG
200MG
200MG
300MG
300MG
200MG
300MG
200MG
300MG
200MG
300MG
50MG
125MG
30MG
EQ 1.5MG BASE
EQ 3MG BASE
EQ 4.5MG BASE
EQ 6MG BASE
100MG EXTENDED
Page 00056
Appl_Type
A
A
A
A
A
A
A
N
A
A
A
A
A
A
A
A
A
N
N
N
N
N
A
A
N
N
A
A
A
A
A
A
A
N
N
N
N
N
A
A
N
N
N
N
N
N
N
N
N
N
A
A
A
A
N
A
A
A
A
A
A
A
A
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
A
62469
2
62594
1
62594
2
61717
1
62142
1
61717
2
62142
2
3444
1 AA
79217
1 AB
79217
2 AB
79217
3 AB
78501
1 AB
78501
2 AB
78501
3 AB
78292
1 AB
78292
2 AB
78292
3 AB
16295
2
16295
3
16295
4
50512
2
50512
1
90095
1 AB
202509
1 AB
16042
3 AB
16042
2
60254
2
62238
1
60254
3
62238
2
63066
1
63067
2 AB
63067
1 AB
19546
1
19546
2
13174
1
13174
2
20647
1 AB
85545
1
83921
1
20193
1
18045
1
21549
3 AB
21549
1 AB
21549
2 AB
21500
1
21775
1
21324
1 AB
205060
1
12455
2
40833
1 AA
91004
1 AA
90455
1 AA
40865
1 AA
203388
1
62162
1
62162
2
62237
1
62087
1
77660
1
77660
2
77660
3
40085
1
16860
1
84463
1
84463
2
84463
3
84463
4
40430
1 AB
40686
1 AB
200892
1 AB
74929
1
74899
1
75126
1
74899
2
75126
2 AB
75419
1 AB
75419
2 AB
74932
1
75071
1
74932
2
75071
2
74840
1
74942
1
74840
2
74942
2
75078
1 AB
75078
2 AB
74842
1
74842
2
74844
1
74844
2
75635
1
18554
1
20989
2 AB
20823
3 AB
20823
4 AB
20823
5 AB
20823
6 AB
40765
1 AB
Approval_Date
31‐Oct‐84
5‐Dec‐85
5‐Dec‐85
20‐Jun‐14
20‐Jun‐14
20‐Jun‐14
19‐Aug‐11
19‐Aug‐11
19‐Aug‐11
27‐Jun‐08
27‐Jun‐08
27‐Jun‐08
25‐Feb‐98
25‐Feb‐98
25‐Feb‐98
21‐Dec‐10
26‐Feb‐14
3‐Mar‐94
14‐Aug‐90
15‐Sep‐99
31‐Jul‐90
20‐Dec‐90
20‐Dec‐90
15‐May‐96
31‐Jul‐84
31‐Jul‐84
26‐Sep‐96
30‐Jun‐06
26‐Mar‐03
26‐Mar‐03
2‐Jul‐03
20‐May‐08
2‐Oct‐01
5‐May‐14
20‐May‐09
14‐Jul‐10
3‐Aug‐10
29‐Dec‐09
30‐Jan‐12
31‐Jul‐07
31‐Jul‐07
31‐Jul‐07
28‐Mar‐96
28‐Oct‐02
28‐May‐08
25‐Sep‐12
30‐Jan‐98
8‐Jul‐97
16‐Sep‐99
8‐Jul‐97
16‐Sep‐99
28‐Jul‐00
28‐Jul‐00
16‐May‐97
30‐Sep‐98
16‐May‐97
30‐Sep‐98
29‐Aug‐97
30‐Sep‐97
29‐Aug‐97
30‐Sep‐97
30‐Apr‐98
30‐Apr‐98
17‐Jul‐97
17‐Jul‐97
23‐Dec‐97
23‐Dec‐97
19‐Sep‐01
27‐Jan‐89
11‐Jan‐00
21‐Apr‐00
21‐Apr‐00
21‐Apr‐00
21‐Apr‐00
12‐Nov‐08
RLD
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
No
Yes
Yes
No
No
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
Yes
No
Yes
Yes
No
No
No
No
Type
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
RX
RX
RX
RX
RX
Applicant_Full_Name
SUPERPHARM CORP
AKORN INC
AKORN INC
AKORN INC
INSYS THERAPEUTICS INC
SVC PHARMA LP
SVC PHARMA LP
SVC PHARMA LP
WARNER CHILCOTT INC
WARNER CHILCOTT INC
GLAXOSMITHKLINE LLC
GLAXOSMITHKLINE LLC
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
COUNTY LINE PHARMACEUTICALS LLC
COVIS PHARMA SARL
COVIS PHARMA SARL
SOMERSET PHARMACEUTICALS INC
MERCK AND CO INC
MERCK AND CO INC
MERCK AND CO INC
GILEAD SCIENCES INC
CUBIST PHARMACEUTICALS INC
ASTRAZENECA LP
ASTRAZENECA PHARMACEUTICALS LP
SIGMAPHARM LABORATORIES LLC
STRIDES PHARMA GLOBAL PTE LTD
GENENTECH INC
MIKART INC
NOVEN THERAPEUTICS LLC
VERSAPHARM INC
AAIPHARMA LLC
ANI PHARMACEUTICALS INC
APOTEX INC
APOTEX INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
DAIICHI SANKYO INC
AMNEAL PHARMACEUTICALS NY LLC
Page 00057
Ingredient
PHENYTOIN SODIUM
PHENYTOIN SODIUM
PHENYTOIN SODIUM
PHENYTOIN SODIUM
PHENYTOIN SODIUM
PHENYTOIN SODIUM
PHENYTOIN SODIUM
PHENYTOIN SODIUM
PHENYTOIN SODIUM
PIROXICAM
PIROXICAM
FENOFIBRATE
FENOFIBRATE
FENOFIBRATE
FENOFIBRATE
FENOFIBRATE
FENOFIBRATE
FENOFIBRATE
FENOFIBRATE
FENOFIBRATE
FENOFIBRATE
FENOFIBRATE
FENOFIBRATE
FENOFIBRATE
FENOFIBRATE
FENOFIBRATE
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
METRONIDAZOLE
TAMSULOSIN HYDROCHLORIDE
FLUCYTOSINE
FLUCYTOSINE
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00058
Trade_Name
FASTIN
FELDENE
FELDENE
FEMCET
FENOFIBRATE (MICRONIZED)
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FIORICET W/ CODEINE
FIORINAL
FIORINAL W/CODEINE
FLAGYL
FLOMAX
FLUCYTOSINE
FLUCYTOSINE
FLUOXETINE
FLUOXETINE
FLUOXETINE
FLUOXETINE
Applicant
ANI PHARMS INC
ANI PHARMS INC
MYLAN
SUN PHARM INDS
SUN PHARM INDS
SUN PHARM INDS (IN)
TARO
WOCKHARDT
WOCKHARDT USA
GLAXOSMITHKLINE
PFIZER
PFIZER
MALLINCKRODT
APOTEX INC
APOTEX INC
DR REDDYS LABS SA
DR REDDYS LABS SA
IMPAX LABS
IMPAX LABS
IMPAX LABS
MYLAN PHARMS INC
MYLAN PHARMS INC
MYLAN PHARMS INC
MYLAN PHARMS INC
MYLAN PHARMS INC
TEVA
TEVA
TEVA
AM THERAP
AM THERAP
HALSEY
HALSEY
PAR PHARM
PAR PHARM
QUANTUM PHARMICS
QUANTUM PHARMICS
SANDOZ
SANDOZ
WARNER CHILCOTT
WARNER CHILCOTT
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
BARR
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
GD SEARLE LLC
SIGMAPHARM LABS LLC
SIGMAPHARM LABS LLC
MUTUAL PHARMA
MUTUAL PHARMA
WATSON LABS
WATSON LABS
ALEMBIC PHARMS LTD
ALEMBIC PHARMS LTD
ALEMBIC PHARMS LTD
ANI PHARMS INC
ANI PHARMS INC
AUROBINDO PHARMA
AUROBINDO PHARMA
AUROBINDO PHARMA
BARR
BARR
BARR
CARLSBAD
CARLSBAD
CR DOUBLE CRANE
CR DOUBLE CRANE
DR REDDYS LABS LTD
DR REDDYS LABS LTD
DR REDDYS LABS LTD
HERITAGE PHARMS INC
HERITAGE PHARMS INC
HERITAGE PHARMS INC
LANDELA PHARM
LANDELA PHARM
MALLINCKRODT
MALLINCKRODT
MYLAN
MYLAN
MYLAN
MYLAN
MYLAN
MYLAN PHARMS INC
MYLAN PHARMS INC
PAR PHARM
PAR PHARM
PAR PHARM
RANBAXY
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
Strength
100MG EXTENDED
100MG EXTENDED
100MG EXTENDED
200MG EXTENDED
300MG EXTENDED
100MG EXTENDED
100MG EXTENDED
30MG EXTENDED
100MG EXTENDED
30MG
10MG
20MG
325MG;50MG;40MG
43MG
130MG
43MG
130MG
67MG
134MG
200MG
43MG
67MG
130MG
134MG
200MG
67MG
134MG
200MG
EQ 200MG BASE
EQ 300MG BASE
EQ 200MG BASE
EQ 300MG BASE
EQ 200MG BASE
EQ 300MG BASE
EQ 200MG BASE
EQ 300MG BASE
EQ 200MG BASE
EQ 300MG BASE
EQ 200MG BASE
EQ 300MG BASE
EQ 200MG BASE
EQ 200MG BASE
EQ 300MG BASE
EQ 300MG BASE
60MG
325MG;50MG;40MG
375MG
0.4MG
250MG
500MG
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 20MG BASE
EQ 40MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
EQ 40MG BASE
EQ 10MG BASE
EQ 10MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 20MG BASE
Page 00059
Appl_Type
A
A
A
A
A
A
A
A
A
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
40435
1
89441
1
40298
1 AB
40731
1 AB
40731
2 AB
40621
1 AB
40684
1 AB
40759
1 AB
40732
1 AB
17352
1
18147
2 AB
18147
3 AB
89102
1
202252
1 AB
202252
2 AB
90859
1 AB
90859
2 AB
75868
1 AB
75868
2 AB
75868
3 AB
202579
1 AB
202676
1 AB
202579
2 AB
202676
2 AB
202676
3 AB
75753
1 AB
75753
2 AB
75753
3 AB
72307
1
72308
1
72355
1
72356
1
72437
1
72438
1
72214
1
71738
1
72394
1
72395
1
72946
1
72472
1
72294
1
72981
1
72293
1
72982
1
76169
1
20232
1 AB
17534
5 AA
19429
3 AB
20334
1 AB
20579
1 AB
201566
1 AB
201566
2 AB
75787
1
75787
2
75662
1
75662
2
90223
1 AB1
90223
2 AB1
90223
3 AB
76287
1 AB2
76287
2 AB2
78619
1 AB1
78619
2 AB1
78619
3 AB
74803
2 AB1
74803
1 AB1
76251
1
76022
1
76022
2
76165
1
76165
2
75465
1 AB1
75465
2 AB1
75465
3 AB
201336
1 AB1
201336
2 AB1
201336
3 AB
75245
2 AB1
75245
1 AB1
75245
3 AB
75464
1 AB1
75464
2 AB1
75658
1 AB1
75658
2 AB1
75207
1 AB1
78045
1 AB2
75207
2 AB1
78045
2 AB2
75207
3 AB
75577
1 AB1
75577
2 AB1
76922
1
76922
2
76922
3 AB
76990
1 AB
75049
1 AB1
75807
1
77469
1 AB2
75049
2 AB1
75807
2
Approval_Date
20‐Jun‐03
18‐Dec‐86
28‐Dec‐98
30‐Jun‐08
30‐Jun‐08
11‐Dec‐06
5‐Sep‐06
18‐Dec‐07
30‐Jan‐08
6‐Apr‐82
6‐Apr‐82
19‐Jun‐85
26‐Jul‐13
26‐Jul‐13
1‐Mar‐12
1‐Mar‐12
27‐Oct‐03
27‐Oct‐03
27‐Oct‐03
10‐Jan‐13
23‐Oct‐12
10‐Jan‐13
23‐Oct‐12
23‐Oct‐12
3‐Sep‐02
9‐Apr‐02
9‐Apr‐02
22‐Aug‐88
22‐Aug‐88
17‐Aug‐88
17‐Aug‐88
22‐Aug‐88
22‐Aug‐88
17‐Aug‐88
17‐Aug‐88
17‐Oct‐88
17‐Oct‐88
30‐Apr‐91
30‐Apr‐91
17‐Aug‐88
19‐Aug‐91
17‐Aug‐88
19‐Aug‐91
13‐Jul‐05
30‐Jul‐92
16‐Apr‐86
26‐Oct‐90
3‐May‐95
15‐Apr‐97
28‐Jun‐11
28‐Jun‐11
29‐Jan‐02
29‐Jan‐02
29‐Jan‐02
29‐Jan‐02
19‐Mar‐09
19‐Mar‐09
19‐Mar‐09
20‐May‐08
20‐May‐08
31‐Jan‐08
31‐Jan‐08
31‐Jan‐08
30‐Jan‐02
2‐Aug‐01
18‐May‐05
30‐Jan‐02
30‐Jan‐02
1‐Feb‐02
1‐Feb‐02
29‐Jan‐02
29‐Jan‐02
2‐Aug‐01
1‐Oct‐12
1‐Oct‐12
1‐Oct‐12
31‐Jan‐02
31‐Jan‐02
28‐Sep‐04
30‐Jan‐02
30‐Jan‐02
29‐Jan‐02
29‐Jan‐02
30‐Jan‐02
17‐Nov‐08
30‐Jan‐02
17‐Nov‐08
25‐May‐07
29‐Jan‐02
29‐Jan‐02
16‐Dec‐04
16‐Dec‐04
16‐Dec‐04
13‐Dec‐04
2‐Aug‐01
29‐Jan‐02
17‐Nov‐08
29‐Jan‐02
29‐Jan‐02
RLD
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Type
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
DISCN
RX
RX
DISCN
Applicant_Full_Name
WOCKHARDT LTD
WOCKHARDT USA INC
GLAXOSMITHKLINE
PFIZER LABORATORIES DIV PFIZER INC
APOTEX INC
APOTEX INC
DR REDDYS LABORATORIES SA
DR REDDYS LABORATORIES SA
HALSEY DRUG CO INC
HALSEY DRUG CO INC
SANDOZ INC
SANDOZ INC
GD SEARLE LLC
MUTUAL PHARMACAL CO
MUTUAL PHARMACAL CO
CARLSBAD TECHNOLOGY INC
CARLSBAD TECHNOLOGY INC
CHINA RESOURCES DOUBLE CRANE PHARMACEUTICAL CO LTD
CHINA RESOURCES DOUBLE CRANE PHARMACEUTICAL CO LTD
LANDELA PHARMACEUTICAL
LANDELA PHARMACEUTICAL
MALLINCKRODT INC
MALLINCKRODT INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
Page 00060
Ingredient
FLUTAMIDE
FLUTAMIDE
FLUTAMIDE
FLUTAMIDE
FLUTAMIDE
FLUVASTATIN SODIUM
FLUVASTATIN SODIUM
FLUVASTATIN SODIUM
FLUVASTATIN SODIUM
FERROUS SULFATE; FOLIC ACID
SAQUINAVIR
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
ZINC ACETATE
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00061
Trade_Name
FLUTAMIDE
FLUTAMIDE
FLUTAMIDE
FLUTAMIDE
FLUTAMIDE
FLUVASTATIN SODIUM
FLUVASTATIN SODIUM
FLUVASTATIN SODIUM
FLUVASTATIN SODIUM
FOLVRON
FORTOVASE
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GABAPENTIN
GALZIN
Applicant
SANDOZ
SANDOZ
TEVA
TEVA
TEVA
TEVA PHARMS USA
TEVA PHARMS USA
WOCKHARDT LTD
WOCKHARDT LTD
WOCKHARDT LTD
HALSEY
HALSEY
HIKMA PHARMS LLC
HIKMA PHARMS LLC
MUTUAL PHARM
MUTUAL PHARM
MYLAN PHARMS INC
MYLAN PHARMS INC
PAR PHARM
PAR PHARM
PUREPAC PHARM
PUREPAC PHARM
SANDOZ
SANDOZ
SUPERPHARM
SUPERPHARM
USL PHARMA
USL PHARMA
WARNER CHILCOTT
WARNER CHILCOTT
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
ACTAVIS LABS FL INC
MYLAN
PAR PHARM
SANDOZ
MYLAN PHARMS INC
MYLAN PHARMS INC
TEVA PHARMS
TEVA PHARMS
LEDERLE
HOFFMANN LA ROCHE
ACTAVIS ELIZABETH
ACTAVIS ELIZABETH
ACTAVIS ELIZABETH
ALKEM
ALKEM
ALKEM
AMNEAL PHARMS NY
AMNEAL PHARMS NY
AMNEAL PHARMS NY
APOTEX INC
APOTEX INC
APOTEX INC
AUROBINDO PHARM
AUROBINDO PHARM
AUROBINDO PHARM
HIKMA
HIKMA
HIKMA
INVAGEN PHARMS
INVAGEN PHARMS
INVAGEN PHARMS
MARKSANS PHARMA
MARKSANS PHARMA
MARKSANS PHARMA
MUTUAL PHARM
MUTUAL PHARM
MUTUAL PHARM
MYLAN
MYLAN
MYLAN
RANBAXY
RANBAXY
RANBAXY
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SUN PHARM INDS LTD
SUN PHARM INDS LTD
SUN PHARM INDS LTD
TARO
TARO
TARO
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
WATSON LABS
WATSON LABS
WATSON LABS
TEVA
Strength
EQ 20MG BASE
EQ 40MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
15MG
30MG
15MG
30MG
15MG
30MG
15MG
30MG
15MG
30MG
15MG
30MG
15MG
30MG
15MG
30MG
15MG
30MG
15MG
30MG
15MG
15MG
30MG
30MG
125MG
125MG
125MG
125MG
125MG
EQ 20MG BASE
EQ 40MG BASE
EQ 20MG BASE
EQ 40MG BASE
182MG;0.33MG
200MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
100MG
300MG
300MG
400MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
100MG
300MG
400MG
EQ 25MG ZINC
Page 00062
Appl_Type
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
77469
2 AB2
75049
3 AB
75452
1 AB1
75452
2 AB1
75452
3 AB
76001
1 AB1
76001
2 AB1
78143
1
78143
2
78143
3
71808
1
71809
1
71107
1
71108
1
70454
1
70455
1
70345
2
70345
1
70444
1
70445
1
71927
1
71551
1
71716
1
71717
1
71659
1
71660
1
70562
1
70563
1
71767
1
71768
1
71205
1
72368
1
71068
1
72369
1
75820
1 AB
75780
1 AB
76224
1 AB
75298
1 AB
75818
1
90595
1 AB
90595
2 AB
78407
1 AB
78407
2 AB
6012
3
20828
1
75350
1 AB
75350
2 AB
75350
3 AB
90858
1 AB
90858
2 AB
90858
3 AB
78428
1 AB
78428
2 AB
78428
3 AB
75360
1 AB
75360
2 AB
75360
3 AB
78787
1 AB
78787
2 AB
78787
3 AB
78150
1 AB
78150
2 AB
78150
3 AB
90705
1 AB
90705
2 AB
90705
3 AB
75477
1
75477
2
75477
3
90007
1 AB
90007
2 AB
90007
3 AB
76537
1
76537
2
76537
3
90158
1 AB
90158
2 AB
90158
3 AB
76606
1 AB
76606
2 AB
76606
3 AB
75428
1
75539
1
75428
2
75539
2
75428
3
75539
3
77242
1 AB
77242
2 AB
77242
3 AB
77261
1 AB
77261
2 AB
77261
3 AB
75435
1 AB
75435
2 AB
75435
3 AB
75485
3
75485
2
75485
1
20458
1
Approval_Date
17‐Nov‐08
29‐Jan‐02
29‐Jan‐02
29‐Jan‐02
29‐Jan‐02
29‐Jan‐02
29‐Jan‐02
16‐Jan‐08
16‐Jan‐08
16‐Jan‐08
7‐Jan‐88
7‐Jan‐88
8‐Dec‐86
8‐Dec‐86
4‐Aug‐86
4‐Aug‐86
27‐Nov‐85
27‐Nov‐85
20‐Mar‐86
20‐Mar‐86
9‐Sep‐87
9‐Sep‐87
31‐Jul‐91
31‐Jul‐91
4‐Aug‐88
4‐Aug‐88
9‐Jul‐87
9‐Jul‐87
4‐Dec‐87
4‐Dec‐87
25‐Nov‐86
30‐Mar‐89
25‐Nov‐86
30‐Mar‐89
18‐Sep‐01
19‐Sep‐01
9‐May‐03
18‐Sep‐01
18‐Sep‐01
11‐Apr‐12
11‐Apr‐12
12‐Jun‐12
12‐Jun‐12
7‐Nov‐97
12‐Sep‐03
12‐Sep‐03
12‐Sep‐03
17‐Dec‐10
17‐Dec‐10
17‐Dec‐10
25‐Jul‐07
25‐Jul‐07
25‐Jul‐07
6‐Apr‐05
6‐Apr‐05
6‐Apr‐05
31‐Jan‐08
31‐Jan‐08
31‐Jan‐08
25‐Sep‐07
25‐Sep‐07
25‐Sep‐07
30‐Dec‐09
30‐Dec‐09
30‐Dec‐09
23‐Mar‐05
23‐Mar‐05
23‐Mar‐05
21‐Jul‐11
21‐Jul‐11
21‐Jul‐11
30‐Jun‐05
30‐Jun‐05
30‐Jun‐05
14‐Feb‐11
14‐Feb‐11
14‐Feb‐11
7‐Oct‐05
7‐Oct‐05
7‐Oct‐05
24‐Jan‐06
6‐Apr‐05
24‐Jan‐06
6‐Apr‐05
24‐Jan‐06
6‐Apr‐05
24‐Aug‐06
24‐Aug‐06
24‐Aug‐06
2‐Aug‐13
2‐Aug‐13
2‐Aug‐13
8‐Oct‐04
8‐Oct‐04
8‐Oct‐04
11‐May‐07
11‐May‐07
11‐May‐07
28‐Jan‐97
RLD
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Type
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
Applicant_Full_Name
SANDOZ INC
SANDOZ INC
WOCKHARDT LTD
WOCKHARDT LTD
WOCKHARDT LTD
HALSEY DRUG CO INC
HALSEY DRUG CO INC
SANDOZ INC
SANDOZ INC
SUPERPHARM CORP
SUPERPHARM CORP
USL PHARMA INC
USL PHARMA INC
WARNER CHILCOTT INC
SANDOZ INC
MYLAN PHARMACEUTICALS INC.
AUROBINDO PHARMA USA INC
MARKSANS PHARMA LTD
MARKSANS PHARMA LTD
MARKSANS PHARMA LTD
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
Page 00063
Ingredient
ZINC ACETATE
GANCICLOVIR
GANCICLOVIR
CROMOLYN SODIUM
GEMFIBROZIL
GEMFIBROZIL
CYCLOSPORINE
CYCLOSPORINE
CYCLOSPORINE
ZIPRASIDONE HYDROCHLORIDE
FINGOLIMOD
IMATINIB MESYLATE
IMATINIB MESYLATE
LOMUSTINE
LOMUSTINE
LOMUSTINE
GRISEOFULVIN, MICROCRYSTALLINE
GRISEOFULVIN, MICROCRYSTALLINE
DOXERCALCIFEROL
DOXERCALCIFEROL
DOXERCALCIFEROL
TASIMELTEON
ALTRETAMINE
PAROMOMYCIN SULFATE
PAROMOMYCIN SULFATE
HYDROXYZINE PAMOATE
TOPOTECAN HYDROCHLORIDE
TOPOTECAN HYDROCHLORIDE
ERGOLOID MESYLATES
HYDROXYUREA
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
HYDROXYUREA
HYDROXYUREA
HYDROXYUREA
HYDROXYUREA
HYDROXYUREA
HYDROXYUREA
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00064
Trade_Name
GALZIN
GANCICLOVIR
GANCICLOVIR
GASTROCROM
GEMFIBROZIL
GEMFIBROZIL
GENGRAF
GENGRAF
GENGRAF
GEODON
GEODON
GEODON
GEODON
GILENYA
GLEEVEC
GLEEVEC
GLEOSTINE
GLEOSTINE
GLEOSTINE
GRISACTIN
GRISACTIN
HECTOROL
HECTOROL
HECTOROL
HETLIOZ
HEXALEN
HUMATIN
HUMATIN
HY‐PAM "25"
HYCAMTIN
HYCAMTIN
HYDERGINE LC
HYDRA‐ZIDE
HYDRA‐ZIDE
HYDRA‐ZIDE
HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50
HYDREA
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
HYDROXYUREA
HYDROXYUREA
HYDROXYUREA
HYDROXYUREA
HYDROXYUREA
HYDROXYUREA
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
Applicant
TEVA
RANBAXY LABS LTD
RANBAXY LABS LTD
UCB INC
MYLAN
PUREPAC PHARM
ABBVIE
ABBVIE
ABBVIE
PFIZER
PFIZER
PFIZER
PFIZER
NOVARTIS
NOVARTIS
NOVARTIS
CORDEN PHARMA
CORDEN PHARMA
CORDEN PHARMA
WYETH AYERST
WYETH AYERST
GENZYME CORP
GENZYME CORP
GENZYME CORP
VANDA PHARMS INC
EISAI INC
KING PFIZER
PARKEDALE
TEVA
GLAXO WELLCOME
GLAXO WELLCOME
NOVARTIS
PAR PHARM
PAR PHARM
PAR PHARM
SOLVAY
SOLVAY
SOLVAY
SUPERPHARM
SUPERPHARM
WATSON LABS
WATSON LABS
WATSON LABS
IVAX PHARMS
IVAX PHARMS
IVAX PHARMS
ALEMBIC PHARMS LTD
APOTEX
AUROBINDO PHARMA
HIKMA INTL PHARMS
IPCA LABS LTD
JUBILANT CADISTA
MYLAN
SUN PHARM INDS INC
UNICHEM
VINTAGE PHARMS
MALLINCKRODT
MALLINCKRODT
MIKART
MIKART
MIKART
MIKART
MIKART
BARR
BARR
BARR LABS INC
BARR LABS INC
PAR PHARM
ROXANE
BARR
BARR
BARR
DURAMED PHARMS BARR
DURAMED PHARMS BARR
DURAMED PHARMS BARR
EMCURE PHARMS USA
EMCURE PHARMS USA
PAR PHARM
PAR PHARM
PAR PHARM
PAR PHARM
PAR PHARM
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SUPERPHARM
SUPERPHARM
SUPERPHARM
VANGARD
VANGARD
WATSON LABS
WATSON LABS
WATSON LABS
Strength
EQ 50MG ZINC
250MG
500MG
100MG
300MG
300MG
25MG
50MG
100MG
EQ 20MG BASE
EQ 40MG BASE
EQ 60MG BASE
EQ 80MG BASE
0.5MG
EQ 50MG BASE
EQ 100MG BASE
10MG
40MG
100MG
125MG
250MG
0.5MCG
1MCG
2.5MCG
20MG
50MG
EQ 250MG BASE
EQ 250MG BASE
EQ 25MG HCL
EQ 0.25MG BASE
EQ 1MG BASE
1MG
25MG;25MG
50MG;50MG
100MG;50MG
25MG;25MG
50MG;50MG
100MG;50MG
25MG;25MG
50MG;50MG
25MG;25MG
50MG;50MG
100MG;50MG
100MG;50MG
25MG;25MG
50MG;50MG
500MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
12.5MG
500MG;5MG
500MG;5MG
500MG;5MG
500MG;5MG
500MG;5MG
500MG;5MG
500MG;5MG
250MG
500MG
250MG
500MG
500MG
500MG
EQ 25MG HCL
EQ 50MG HCL
EQ 100MG HCL
EQ 25MG HCL
EQ 50MG HCL
EQ 100MG HCL
EQ 25MG HYDROCHLORIDE
EQ 25MG HCL
EQ 50MG HCL
EQ 25MG HCL
EQ 25MG HCL
EQ 50MG HCL
EQ 50MG HCL
EQ 100MG HCL
EQ 25MG HCL
EQ 25MG HCL
EQ 50MG HCL
EQ 50MG HCL
EQ 100MG HCL
EQ 25MG HCL
EQ 50MG HCL
EQ 100MG HCL
EQ 25MG HCL
EQ 50MG HCL
EQ 25MG HCL
EQ 25MG HCL
Page 00065
Appl_Type
N
A
A
N
A
A
A
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
20458
2
76457
1
76457
2
19188
1
73466
1
72929
1
65003
1 AB1
65003
2 AB1
65003
3 AB1
20825
1 AB
20825
2 AB
20825
3 AB
20825
4 AB
22527
1
21335
1
21335
2
17588
1
17588
2
17588
3
50051
2
50051
1
20862
2 AB
20862
3 AB
20862
1 AB
205677
1
19926
1
62310
1
60521
1
88713
1
20981
1
20981
2
18706
1
88957
1
88946
1
88961
1
87608
1
87213
1
87609
1
89200
1
89201
1
85457
1
85446
1
85440
1
88358
1
88356
1
88357
1
16295
1 AB
200645
1 AB
78389
1 AB
78164
1 AB
77885
1
79237
1 AB
77005
1 AB
78391
1 AB
91662
1 AB
75640
1 AB
90651
1 AB
90510
1 AB
75907
1 AB
88956
1
89006
1
81067
1
81068
1
81069
1
81070
1
89008
1
75143
2
75143
1 AB
75020
2
75020
1
75340
1 AB
74476
1
88496
1 AB
88487
1 AB
88488
1
88593
1
88594
1
88595
1
201507
1 AB
201507
2 AB
87761
1
87760
1
87656
1
89145
1
87657
1
89146
1
87658
1
81127
1
87479
1 AB
81128
1
86183
1 AB
81129
1
89031
1
89032
1
89033
1
88392
1
88393
1
40156
1 AB
81165
1
86698
1
Approval_Date
28‐Jan‐97
27‐Jun‐03
27‐Jun‐03
22‐Dec‐89
25‐Jan‐93
29‐Jan‐93
12‐May‐00
12‐May‐00
12‐May‐00
5‐Feb‐01
5‐Feb‐01
5‐Feb‐01
5‐Feb‐01
21‐Sep‐10
10‐May‐01
10‐May‐01
23‐Apr‐04
13‐Jul‐09
9‐Jun‐99
31‐Jan‐14
26‐Dec‐90
4‐Mar‐85
11‐Oct‐07
11‐Oct‐07
18‐Jan‐83
21‐Oct‐85
21‐Oct‐85
21‐Oct‐85
8‐Feb‐82
8‐Feb‐82
8‐Feb‐82
9‐Feb‐87
9‐Feb‐87
4‐Mar‐82
4‐Mar‐82
4‐Mar‐82
10‐Apr‐84
10‐Apr‐84
10‐Apr‐84
30‐Nov‐10
16‐May‐08
18‐Sep‐07
26‐Nov‐07
2‐Apr‐09
13‐Jul‐05
11‐Feb‐08
27‐Jan‐12
28‐Jan‐00
7‐Apr‐14
19‐Jan‐10
17‐Sep‐02
19‐Jul‐85
9‐Aug‐85
30‐Nov‐89
30‐Nov‐89
30‐Nov‐89
30‐Nov‐89
21‐Feb‐86
21‐Sep‐00
16‐Oct‐98
26‐Jun‐00
30‐Jul‐98
24‐Feb‐99
18‐Aug‐95
15‐Jun‐84
15‐Jun‐84
15‐Jun‐84
29‐Feb‐84
29‐Feb‐84
29‐Feb‐84
3‐Jun‐13
3‐Jun‐13
5‐Mar‐82
5‐Mar‐82
11‐Jun‐82
17‐Mar‐86
11‐Jun‐82
17‐Mar‐86
11‐Jun‐82
28‐Jun‐91
28‐Jun‐91
28‐Jun‐91
2‐Jan‐87
2‐Jan‐87
2‐Jan‐87
19‐Sep‐83
19‐Sep‐83
15‐Jul‐96
31‐Jul‐91
RLD
Yes
No
No
No
No
No
No
No
No
Yes
No
No
No
Yes
No
No
No
No
Yes
No
No
No
No
Yes
Yes
Yes
No
No
No
No
Yes
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Type
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
RX
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
Applicant_Full_Name
UCB INC
ABBVIE INC
ABBVIE INC
ABBVIE INC
PFIZER INC
PFIZER INC
PFIZER INC
PFIZER INC
CORDEN PHARMA LATINA SPA
GENZYME CORP
GENZYME CORP
GENZYME CORP
VANDA PHARMACEUTICALS INC
EISAI INC
KING PHARMACEUTICALS INC SUB PFIZER INC
GLAXOSMITHKLINE
GLAXOSMITHKLINE
SUPERPHARM CORP
SUPERPHARM CORP
APOTEX INC
IPCA LABORATORIES LTD
JUBILANT CADISTA PHARMACEUTICALS INC
UNICHEM LABORATORIES LTD
MIKART INC
MIKART INC
MIKART INC
MIKART INC
MIKART INC
EMCURE PHARMACEUTICALS USA INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SUPERPHARM CORP
SUPERPHARM CORP
SUPERPHARM CORP
Page 00066
Ingredient
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
TERAZOSIN HYDROCHLORIDE
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
IBUPROFEN
IBUPROFEN
IBUPROFEN
IBUPROFEN
IBUPROFEN
IBRUTINIB
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
LOPERAMIDE HYDROCHLORIDE
MILTEFOSINE
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
SAQUINAVIR MESYLATE
SODIUM IODIDE I‐131
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00067
Trade_Name
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
Applicant
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
HYTRIN
ABBOTT
HYTRIN
ABBOTT
HYTRIN
ABBOTT
HYTRIN
IBUPROFEN
IBUPROFEN
IBUPROFEN
IBUPROFEN
IBUPROFEN
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
ILOSONE
ILOSONE
IMBRUVICA
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
IMODIUM
IMODIUM
IMPAVIDO
INDO‐LEMMON
INDO‐LEMMON
INDOCIN
INDOCIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INDOMETHACIN
INVIRASE
IODOTOPE
ABBOTT
AMNEAL PHARMS
BANNER PHARMACAPS
CONTRACT PHARMACAL
MARKSANS PHARMA
P AND L DEV LLC
BANNER PHARMACAPS
STRIDES PHARMA
LILLY
LILLY
PHARMACYCLICS INC
LUPIN LTD
LUPIN LTD
LUPIN LTD
LUPIN LTD
MYLAN PHARMS INC
MYLAN PHARMS INC
MYLAN PHARMS INC
MYLAN PHARMS INC
ROXANE
ROXANE
ROXANE
ROXANE
MCNEIL CONS
MCNEIL PED
KNIGHT THERAPS
TEVA
TEVA
IROKO PHARMS LLC
IROKO PHARMS LLC
ABLE
ABLE
CYCLE PHARMS LTD
CYCLE PHARMS LTD
DURAMED PHARMS BARR
DURAMED PHARMS BARR
GLENMARK GENERICS
GLENMARK GENERICS
HALSEY
HALSEY
HERITAGE PHARMS INC
HERITAGE PHARMS INC
HETERO LABS LTD III
HETERO LABS LTD III
MUTUAL PHARM
MUTUAL PHARM
MUTUAL PHARM
MUTUAL PHARM
MYLAN
MYLAN
MYLAN
PARKE DAVIS
PARKE DAVIS
PIONEER PHARMS
PIONEER PHARMS
PLIVA
PLIVA
SANDOZ
SANDOZ
SUN PHARM INDS INC
SUN PHARM INDS INC
SUPERPHARM
SUPERPHARM
TEVA
TEVA
VINTAGE
VINTAGE
VINTAGE
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
HOFFMANN LA ROCHE
BRACCO
Strength
EQ 25MG HCL
EQ 50MG HCL
EQ 50MG HCL
EQ 50MG HCL
EQ 50MG HCL
EQ 100MG HCL
EQ 100MG HCL
EQ 100MG HCL
EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
200MG
EQ 125MG BASE
EQ 250MG BASE
140MG
EQ 75MG HCL
EQ 100MG HCL
EQ 125MG HCL
EQ 150MG HCL
EQ 75MG HCL
EQ 100MG HCL
EQ 125MG HCL
EQ 150MG HCL
EQ 75MG HCL
EQ 100MG HCL
EQ 125MG HCL
EQ 150MG HCL
2MG
2MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
25MG
50MG
50MG
25MG
25MG
50MG
50MG
25MG
50MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
25MG
50MG
50MG
25MG
25MG
25MG
25MG
50MG
50MG
50MG
50MG
50MG
25MG
50MG
EQ 200MG BASE
1‐130mCi
Page 00068
Appl_Type
A
A
A
A
A
A
A
A
86840
1
40156
2 AB
86695
1
86705
1
87767
1
86697
1
86728
1
87790
1
Approval_Date
1‐Jul‐82
15‐Jul‐96
1‐Jul‐82
16‐Aug‐82
5‐Oct‐82
16‐Aug‐82
RLD
No
No
No
No
No
No
No
No
Type
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
Applicant_Full_Name
N
20347
1
14‐Dec‐94 No
DISCN ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
N
20347
2
14‐Dec‐94 No
N
20347
3
N
A
A
A
A
A
A
A
A
A
N
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
A
A
N
N
A
A
A
A
A
A
A
A
A
A
N
N
A
A
A
N
A
N
A
A
A
A
N
A
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
N
A
N
A
A
A
N
A
A
A
A
N
A
A
N
N
20347
202300
78682
74782
79205
77338
90397
200888
61897
61897
205552
90444
90444
90444
90444
202338
202338
202338
202338
91099
91099
91099
91099
17694
17690
204684
70266
70267
16059
16059
76666
76666
70353
70354
70326
70327
91276
91276
70782
70635
18851
18851
91240
91240
70719
18730
70756
18730
70067
70899
70068
70900
18858
70624
18858
18806
18806
70813
70592
71148
71149
70673
70674
91401
91401
70487
70488
71342
71343
18829
70651
18829
70529
70784
72996
18690
70530
70785
71635
72997
18690
90403
90403
20628
10929
4
1
1
1
1
1
1
1
1
2
1
1
2
3
4
1
2
3
4
1
2
3
4
1
1
1
1
1
1
2
1
2
1
1
1
1
1
2
1
1
1
2
1
2
1
1
1
2
1
1
1
1
1
1
2
1
2
1
1
1
1
1
1
1
2
1
1
1
1
2
1
1
1
1
1
1
1
1
1
1
2
1
2
1
1
14‐Dec‐94 No
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
14‐Dec‐94
23‐Dec‐11
24‐Mar‐09
6‐Jul‐98
26‐Jun‐09
10‐Jul‐09
22‐Nov‐10
5‐Mar‐12
13‐Nov‐13
16‐Apr‐10
16‐Apr‐10
16‐Apr‐10
16‐Apr‐10
28‐Jun‐13
28‐Jun‐13
28‐Jun‐13
28‐Jun‐13
16‐Apr‐10
16‐Apr‐10
16‐Apr‐10
16‐Apr‐10
19‐Mar‐14
7‐Nov‐85
7‐Nov‐85
17‐Dec‐03
17‐Dec‐03
18‐Jun‐85
18‐Jun‐85
18‐Oct‐85
18‐Oct‐85
22‐Dec‐10
22‐Dec‐10
3‐Jun‐87
3‐Jun‐87
18‐May‐84
18‐May‐84
12‐Apr‐11
12‐Apr‐11
12‐Feb‐86
4‐May‐84
12‐Feb‐86
4‐May‐84
3‐Oct‐86
9‐Feb‐87
3‐Oct‐86
9‐Feb‐87
20‐Apr‐84
4‐Sep‐85
20‐Apr‐84
23‐Nov‐84
23‐Nov‐84
11‐Aug‐86
11‐Aug‐86
18‐Mar‐87
18‐Mar‐87
29‐Apr‐87
29‐Apr‐87
28‐Mar‐13
28‐Mar‐13
10‐Oct‐86
10‐Oct‐86
18‐Apr‐88
18‐Apr‐88
6‐Aug‐84
5‐Mar‐86
6‐Aug‐84
18‐Oct‐85
20‐Aug‐86
31‐Jul‐91
31‐Jul‐84
18‐Oct‐85
20‐Aug‐86
18‐May‐87
31‐Jul‐91
31‐Jul‐84
15‐Nov‐10
15‐Nov‐10
6‐Dec‐95
No
No
No
Yes
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
DISCN
OTC
OTC
OTC
OTC
OTC
OTC
OTC
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
CONTRACT PHARMACAL CORP
MARKSANS PHARMA LTD
P AND L DEVELOPMENT LLC DBA PLD DEVELOPMENTS LLC
ELI LILLY AND CO
ELI LILLY AND CO
PHARMACYCLICS INC
LUPIN LTD
LUPIN LTD
LUPIN LTD
LUPIN LTD
MCNEIL PEDIATRICS
KNIGHT THERAPEUTICS USA INC
CYCLE PHARMACEUTICALS LTD
GLENMARK GENERICS LTD INDIA
GLENMARK GENERICS LTD INDIA
HALSEY DRUG CO INC
HALSEY DRUG CO INC
PLIVA INC
PLIVA INC
SANDOZ INC
SANDOZ INC
SUPERPHARM CORP
SUPERPHARM CORP
BRACCO DIAGNOSTICS INC
Page 00069
Ingredient
ISRADIPINE
ISRADIPINE
ISRADIPINE
ISRADIPINE
ITRACONAZOLE
ITRACONAZOLE
DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
LOMITAPIDE MESYLATE
LOMITAPIDE MESYLATE
LOMITAPIDE MESYLATE
CEPHALOGLYCIN
LOPINAVIR; RITONAVIR
KANAMYCIN SULFATE
KANAMYCIN SULFATE
KANAMYCIN SULFATE
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
KETOPROFEN
KETOPROFEN
KETOPROFEN
KETOPROFEN
KETOPROFEN
KETOPROFEN
KETOPROFEN
KETOPROFEN
KETOPROFEN
KETOPROFEN
CLOFAZIMINE
CLOFAZIMINE
DIGOXIN
DIGOXIN
DIGOXIN
DIGOXIN
LEVODOPA
LEVODOPA
LEVODOPA
FLUVASTATIN SODIUM
FLUVASTATIN SODIUM
LINCOMYCIN HYDROCHLORIDE
LINCOMYCIN HYDROCHLORIDE
LINACLOTIDE
LINACLOTIDE
FENOFIBRATE
FENOFIBRATE
FENOFIBRATE
FENOFIBRATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
ETODOLAC
ETODOLAC
GEMFIBROZIL
GEMFIBROZIL
CHLORTHALIDONE; METOPROLOL TARTRATE
CHLORTHALIDONE; METOPROLOL TARTRATE
LORACARBEF
LORACARBEF
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00070
Trade_Name
IODOTOPE
ISRADIPINE
ISRADIPINE
ISRADIPINE
ISRADIPINE
ITRACONAZOLE
ITRACONAZOLE
JALYN
JUXTAPID
JUXTAPID
JUXTAPID
KAFOCIN
KALETRA
KANTREX
KANTREX
KANTREX
KEFLEX
KEFLEX
KEFLEX
KEFLEX
KESSO‐GESIC
KETOPROFEN
KETOPROFEN
KETOPROFEN
KETOPROFEN
KETOPROFEN
KETOPROFEN
KETOPROFEN
KETOPROFEN
KETOPROFEN
KETOPROFEN
LAMPRENE
LAMPRENE
LANORINAL
LANOXICAPS
LANOXICAPS
LANOXICAPS
LANOXICAPS
LARODOPA
LARODOPA
LARODOPA
LESCOL
LESCOL
LIBRIUM
LIBRIUM
LIBRIUM
LIBRIUM
LIBRIUM
LIBRIUM
LINCOCIN
LINCOCIN
LINZESS
LINZESS
LIPIDIL
LIPOFEN
LIPOFEN
LIPOFEN
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHIUM CARBONATE
LITHONATE
LODINE
LODINE
LOPID
LOPID
LOPRESSIDONE
LOPRESSIDONE
LORABID
LORABID
LORCET‐HD
LOTREL
LOTREL
LOTREL
LOTREL
Applicant
BRACCO
MIKAH PHARMA
MIKAH PHARMA
WATSON LABS
WATSON LABS
MYLAN PHARMS INC
SANDOZ
GLAXOSMITHKLINE
AEGERION
AEGERION
AEGERION
LILLY
ABBVIE
APOTHECON
APOTHECON
APOTHECON
SHIONOGI INC
SHIONOGI INC
SHIONOGI INC
SHIONOGI INC
MK LABS
DORADO PHARMA
DORADO PHARMA
DORADO PHARMA
MYLAN
MYLAN
SANDOZ
SANDOZ
TEVA
TEVA
TEVA
NOVARTIS
NOVARTIS
LANNETT
GLAXOSMITHKLINE LLC
GLAXOSMITHKLINE LLC
GLAXOSMITHKLINE LLC
GLAXOSMITHKLINE LLC
ROCHE
ROCHE
ROCHE
NOVARTIS
NOVARTIS
VALEANT PHARM INTL
VALEANT PHARM INTL
VALEANT PHARM INTL
VALEANT PHARM INTL
VALEANT PHARM INTL
VALEANT PHARM INTL
FOREST LABS INC
FOREST LABS INC
ABBVIE
CIPHER PHARMS INC
CIPHER PHARMS INC
CIPHER PHARMS INC
ABLE
ABLE
ABLE
ABLE
ALEMBIC LTD
ALEMBIC LTD
ALEMBIC LTD
APOTEX INC
GLENMARK GENERICS
GLENMARK GENERICS
GLENMARK GENERICS
HETERO LABS LTD III
HETERO LABS LTD III
HETERO LABS LTD III
HIKMA INTL PHARMS
HIKMA INTL PHARMS
HIKMA PHARMS LLC
ROXANE
ROXANE
ROXANE
USL PHARMA
WATSON LABS
SOLVAY
WYETH PHARMS INC
WYETH PHARMS INC
BANNER PHARMACAPS
BANNER PHARMACAPS
MYLAN
ROXANE
SANDOZ
TEVA
TEVA
PFIZER PHARMS
PFIZER PHARMS
NOVARTIS
NOVARTIS
KING PHARMS
KING PHARMS
MALLINCKRODT
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS
Strength
1‐150mCi
2.5MG
5MG
2.5MG
5MG
100MG
100MG
0.5MG;0.4MG
EQ 5MG BASE
EQ 10MG BASE
EQ 20MG BASE
250MG
133.3MG;33.3MG
EQ 500MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 333MG BASE
EQ 500MG BASE
EQ 750MG BASE
65MG
25MG
50MG
75MG
50MG
75MG
50MG
75MG
25MG
50MG
75MG
50MG
100MG
325MG;50MG;40MG
0.05MG
0.1MG
0.15MG
0.2MG
100MG
250MG
500MG
EQ 20MG BASE
EQ 40MG BASE
5MG
5MG
10MG
10MG
25MG
25MG
EQ 250MG BASE
EQ 500MG BASE
145MCG
290MCG
100MG
50MG
100MG
150MG
150MG
300MG
300MG
600MG
150MG
300MG
600MG
300MG
150MG
300MG
600MG
150MG
300MG
600MG
150MG
300MG
600MG
150MG
300MG
600MG
300MG
300MG
300MG
200MG
300MG
1MG
2MG
2MG
2MG
2MG
2MG
2MG
200MG
300MG
25MG;100MG
25MG;200MG
200MG
400MG
500MG;5MG
EQ 2.5MG BASE;10MG
EQ 5MG BASE;10MG
EQ 5MG BASE;20MG
EQ 5MG BASE;40MG
Page 00071
Appl_Type
N
A
A
A
A
A
A
N
N
N
N
N
N
A
A
A
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
N
N
A
N
N
N
N
N
N
N
N
N
A
N
A
N
A
N
N
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
A
A
N
N
N
N
N
A
A
A
A
A
N
N
N
N
N
N
A
N
N
N
N
10929
3
77169
1 AB
77169
2 AB
77317
1 AB
77317
2 AB
200463
1 AB
76104
1 AB
22460
1 AB
203858
1
203858
2
203858
3
50219
1
21226
1
60516
1
61911
1
62726
1
50405
2 AB
50405
4
50405
3 AB
50405
5 AB
83544
1
74014
1
74014
2 AB
74014
3 AB
74035
2 AB
74035
3 AB
74024
1
74024
2
73515
1
73516
1 AB
73517
1 AB
19500
2
19500
1
86996
2 AA
18118
2
18118
3
18118
4
18118
1
16912
2
16912
1
16912
6
20261
1 AB
20261
2 AB
85461
1 AB
12249
2
85472
1 AB
12249
1
85475
1 AB
12249
3
50316
1
50316
2
202811
1
202811
2
19304
1
21612
1
21612
2
21612
3
76823
1
76121
1
76823
2
76823
3
79159
1 AB
79159
2 AB
79159
3 AB
76795
1
79139
1 AB
79139
2 AB
79139
3 AB
90702
1 AB
90702
2 AB
90702
3 AB
76243
2 AB
76243
1 AB
78763
1
17812
2 AB
17812
1 AB
17812
3 AB
72542
1
70407
1
16782
1
18922
2
18922
3
21855
1
21855
2
72741
1 AB
73080
1
72993
1
73122
1
73192
1 AB
18422
1
18422
2
19451
1
19451
2
50668
1
50668
2
87336
1
20364
2 AB
20364
3 AB
20364
4 AB
20364
7 AB
Approval_Date
24‐Apr‐06
24‐Apr‐06
5‐Jan‐06
5‐Jan‐06
20‐Jul‐12
28‐May‐04
14‐Jun‐10
21‐Dec‐12
21‐Dec‐12
21‐Dec‐12
15‐Sep‐00
6‐Mar‐87
12‐May‐06
12‐May‐06
29‐Jan‐93
29‐Jan‐93
29‐Jan‐93
31‐Dec‐96
31‐Dec‐96
29‐Dec‐95
29‐Dec‐95
22‐Dec‐92
22‐Dec‐92
22‐Dec‐92
15‐Dec‐86
15‐Dec‐86
11‐Oct‐85
26‐Jul‐82
26‐Jul‐82
24‐Sep‐84
26‐Jul‐82
31‐Dec‐93
31‐Dec‐93
30‐Aug‐12
30‐Aug‐12
31‐Dec‐93
11‐Jan‐06
11‐Jan‐06
11‐Jan‐06
29‐Jun‐04
27‐Sep‐01
29‐Jun‐04
29‐Jun‐04
12‐Jan‐09
12‐Jan‐09
12‐Jan‐09
22‐Nov‐04
3‐Feb‐09
3‐Feb‐09
3‐Feb‐09
25‐Sep‐09
25‐Sep‐09
25‐Sep‐09
24‐Feb‐03
27‐Jun‐02
15‐Apr‐08
28‐Jan‐87
28‐Jan‐87
1‐Feb‐89
19‐Mar‐87
31‐Jan‐91
31‐Jan‐91
4‐Aug‐05
4‐Aug‐05
18‐Sep‐91
27‐Nov‐91
28‐Aug‐92
30‐Aug‐91
30‐Apr‐92
31‐Dec‐87
31‐Dec‐87
31‐Dec‐91
5‐Apr‐96
8‐Jul‐82
3‐Mar‐95
3‐Mar‐95
3‐Mar‐95
11‐Apr‐06
RLD
No
No
No
No
Yes
No
No
Yes
No
No
Yes
No
Yes
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
Yes
No
No
No
No
Yes
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Type
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
DISCN
DISCN
DISCN
RX
DISCN
RX
RX
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
RX
DISCN
RX
DISCN
DISCN
DISCN
RX
RX
DISCN
RX
DISCN
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
OTC
OTC
RX
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
Applicant_Full_Name
MIKAH PHARMA LLC
MIKAH PHARMA LLC
SANDOZ INC
GLAXOSMITHKLINE
AEGERION PHARMACEUTICALS INC
ELI LILLY AND CO
ABBVIE INC
SHIONOGI INC
SHIONOGI INC
SHIONOGI INC
SHIONOGI INC
MK LABORATORIES INC
DORADO PHARMA LLC
DORADO PHARMA LLC
DORADO PHARMA LLC
SANDOZ INC
SANDOZ INC
LANNETT CO INC
GLAXOSMITHKLINE LLC
GLAXOSMITHKLINE LLC
GLAXOSMITHKLINE LLC
GLAXOSMITHKLINE LLC
ABBVIE INC
ALEMBIC LTD
ALEMBIC LTD
ALEMBIC LTD
APOTEX INC
GLENMARK GENERICS LTD
USL PHARMA INC
SANDOZ INC
PFIZER PHARMACEUTICALS LTD
Page 00072
Ingredient
OMEGA‐3‐ACID ETHYL ESTERS
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
NITROFURANTOIN, MACROCRYSTALLINE
DRONABINOL
DRONABINOL
DRONABINOL
PROCARBAZINE HYDROCHLORIDE
MECLOFENAMATE SODIUM
MEFENAMIC ACID
MEFENAMIC ACID
MEFENAMIC ACID
MEFENAMIC ACID
SIBUTRAMINE HYDROCHLORIDE
METHOXSALEN
METHOXSALEN
METHYLTESTOSTERONE
METYRAPONE
METRONIDAZOLE
METRONIDAZOLE
METRONIDAZOLE
MEXILETINE HYDROCHLORIDE
HYDROCHLOROTHIAZIDE
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
IBUPROFEN
CAPSULE;ORAL
Page 00073
Trade_Name
LOTREL
LOTREL
LOVAZA
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXAPINE SUCCINATE
LOXITANE
LOXITANE
LOXITANE
LOXITANE
LYGEN
LYGEN
LYGEN
LYRICA
LYRICA
LYRICA
LYRICA
LYRICA
LYRICA
LYRICA
LYRICA
MACROBID
MACRODANTIN
MACRODANTIN
MACRODANTIN
MARINOL
MARINOL
MARINOL
MATULANE
MECLODIUM
MECLODIUM
MECLOMEN
MECLOMEN
MEDIGESIC PLUS
MEFENAMIC ACID
MEFENAMIC ACID
MEFENAMIC ACID
MEFENAMIC ACID
MERIDIA
MERIDIA
MERIDIA
METHOXSALEN
METHOXSALEN
METHYLTESTOSTERONE
METOPIRONE
METRONIDAZOLE
METRONIDAZOLE
METRONIDAZOLE
MEXITIL
MEXITIL
MEXITIL
MICROZIDE
Applicant
NOVARTIS
NOVARTIS
SMITHKLINE BEECHAM
MIKAH PHARMA
MIKAH PHARMA
MIKAH PHARMA
MIKAH PHARMA
MYLAN
MYLAN
MYLAN
MYLAN
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
ALRA
ALRA
ALRA
PF PRISM
PF PRISM
PF PRISM
PF PRISM
PF PRISM
PF PRISM
PF PRISM
PF PRISM
ALVOGEN INC
ALVOGEN INC
ALVOGEN INC
ALVOGEN INC
ABBVIE
ABBVIE
ABBVIE
SIGMA TAU
QUANTUM PHARMICS
QUANTUM PHARMICS
AM THERAP
AM THERAP
BARR
BARR
MYLAN
MYLAN
PAR PHARM
PAR PHARM
SANDOZ
SANDOZ
USL PHARMA
USL PHARMA
VITARINE
VITARINE
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
PARKE DAVIS
PARKE DAVIS
US CHEM
BRECKENRIDGE PHARM
LUPIN LTD
MICRO LABS LTD
VINTAGE PHARMS LLC
ABBOTT
ABBOTT
ABBOTT
SANDOZ
STRIDES PHARMA
HEATHER
HRA PHARMA
ABLE
ALEMBIC LTD
PAR PHARM
SANDOZ
SANDOZ
SANDOZ
TEVA
TEVA
TEVA
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
MIDOL
BAYER
Strength
EQ 10MG BASE;20MG
EQ 10MG BASE;40MG
1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA‐3 FATTY ACIDS
EQ 5MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
5MG
10MG
25MG
25MG
50MG
75MG
100MG
150MG
200MG
225MG
300MG
75MG;25MG
25MG
50MG
100MG
2.5MG
5MG
10MG
EQ 50MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 50MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 100MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE
325MG;50MG;40MG
250MG
250MG
250MG
250MG
5MG
10MG
15MG
10MG
10MG
10MG
250MG
375MG
375MG
375MG
150MG
200MG
250MG
150MG
200MG
250MG
150MG
150MG
200MG
200MG
250MG
250MG
150MG
200MG
250MG
12.5MG
Page 00074
Appl_Type
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
A
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
A
A
A
A
A
N
N
N
A
A
A
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
A
20364
5 AB
20364
6 AB
21654
1 AB
90695
1 AB
90695
2 AB
90695
3 AB
90695
4 AB
76868
1 AB
76868
2 AB
76868
3 AB
76868
4 AB
76762
1 AB
76762
2 AB
76762
3 AB
76762
4 AB
72204
1 AB
72205
1 AB
72206
1 AB
72062
1 AB
17525
1
17525
2
17525
3
17525
4
85107
1
85009
1
85108
1
21446
1 AB
21446
2 AB
21446
3 AB
21446
4 AB
21446
5 AB
21446
6 AB
21446
7 AB
21446
8 AB
20064
1 AB
16620
3
16620
1 AB
16620
2 AB
18651
1 AB
18651
2 AB
18651
3 AB
16785
1
71380
1
71381
1
71362
1
71363
1
72848
1
72809
1
71081
2
71081
1
72077
1
72078
1
72262
1
72263
1
71007
1
71008
1
71710
1
71684
1
70400
1
71468
1
71640
1
70401
1
71469
1
71641
1
18006
1
18006
2
89115
1
90359
1 AB
91322
1 AB
90562
1 AB
91608
1 AB
20632
1
20632
2
20632
3
87781
1
202687
1 AB
84967
1
12911
2
76505
1
79065
1 AB
76522
1 AB
74450
1
74450
2
74450
3
74377
1
74377
2
74377
3
74711
1
74865
1
74711
2
74865
2
74711
3
74865
3
18873
2
18873
3
18873
4
20504
1 AB
70626
1
Approval_Date
20‐Jun‐02
11‐Apr‐06
10‐Nov‐04
26‐Sep‐11
26‐Sep‐11
26‐Sep‐11
26‐Sep‐11
4‐Aug‐05
4‐Aug‐05
4‐Aug‐05
4‐Aug‐05
1‐Nov‐04
1‐Nov‐04
1‐Nov‐04
1‐Nov‐04
15‐Jun‐88
15‐Jun‐88
15‐Jun‐88
15‐Jun‐88
30‐Dec‐04
30‐Dec‐04
30‐Dec‐04
30‐Dec‐04
30‐Dec‐04
30‐Dec‐04
30‐Dec‐04
30‐Dec‐04
24‐Dec‐91
31‐May‐85
31‐May‐85
31‐May‐85
14‐Jul‐87
14‐Jul‐87
10‐Feb‐87
10‐Feb‐87
20‐Mar‐89
20‐Mar‐89
3‐Sep‐86
3‐Sep‐86
10‐Mar‐88
10‐Mar‐88
29‐Nov‐88
29‐Nov‐88
25‐Mar‐88
25‐Mar‐88
15‐Jun‐88
15‐Jun‐88
25‐Nov‐86
15‐Apr‐87
11‐Aug‐87
25‐Nov‐86
15‐Apr‐87
11‐Aug‐87
14‐Jan‐86
5‐Feb‐13
22‐Jul‐11
19‐Nov‐10
2‐Jun‐14
22‐Nov‐97
22‐Nov‐97
22‐Nov‐97
8‐Jun‐82
5‐Jun‐14
9‐Aug‐96
13‐Nov‐03
23‐Jun‐09
29‐Jan‐04
16‐May‐96
16‐May‐96
16‐May‐96
16‐May‐95
16‐May‐95
16‐May‐95
26‐Feb‐97
13‐Apr‐98
26‐Feb‐97
13‐Apr‐98
26‐Feb‐97
13‐Apr‐98
30‐Dec‐85
30‐Dec‐85
30‐Dec‐85
27‐Dec‐96
RLD
No
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
No
Yes
No
Yes
No
Yes
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
Yes
2‐Sep‐87 No
Type
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
DISCN
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
Applicant_Full_Name
SMITHKLINE BEECHAM
MIKAH PHARMA LLC
MIKAH PHARMA LLC
MIKAH PHARMA LLC
MIKAH PHARMA LLC
PF PRISM CV
PF PRISM CV
PF PRISM CV
PF PRISM CV
PF PRISM CV
PF PRISM CV
PF PRISM CV
PF PRISM CV
ALVOGEN INC
ALVOGEN INC
ALVOGEN INC
ALVOGEN INC
ABBVIE INC
ABBVIE INC
ABBVIE INC
SIGMA TAU PHARMACEUTICALS INC
SANDOZ INC
SANDOZ INC
USL PHARMA INC
USL PHARMA INC
US CHEMICAL MARKETING GROUP INC
LUPIN LTD
MICRO LABS LTD
SANDOZ INC
HEATHER DRUG CO INC
HRA PHARMA LLC
ALEMBIC LTD
SANDOZ INC
SANDOZ INC
SANDOZ INC
DISCN BAYER HEALTHCARE LLC
Page 00075
Ingredient
DF;Route
IBUPROFEN
IBUPROFEN
PHENSUXIMIDE
PRAZOSIN HYDROCHLORIDE
POLYTHIAZIDE; PRAZOSIN HYDROCHLORIDE
COLCHICINE
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
MOLINDONE HYDROCHLORIDE
CAPSULE;ORAL
CAPSULE;ORAL
TRILOSTANE
TRILOSTANE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
RIFABUTIN
ISOTRETINOIN
ISOTRETINOIN
ISOTRETINOIN
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
FENOPROFEN CALCIUM
NAPROXEN SODIUM
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
PENTOBARBITAL SODIUM
CYCLOSPORINE
CYCLOSPORINE
CYCLOSPORINE
GABAPENTIN
GABAPENTIN
GABAPENTIN
NIFEDIPINE
NIFEDIPINE
NIFEDIPINE
NIFEDIPINE
NIFEDIPINE
NIFEDIPINE
NIFEDIPINE
NIFEDIPINE
NIFEDIPINE
NIFEDIPINE
NIMODIPINE
NIMODIPINE
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00076
Trade_Name
Applicant
MIDOL
MIDOL LIQUID GELS
MILONTIN
MINIPRESS
MINIPRESS
MINIPRESS
MINIZIDE
MINIZIDE
MINIZIDE
MINOCIN
MINOCIN
MINOCIN
MINOCIN
MINOCIN
MITIGARE
BAYER
BANNER PHARMACAPS
PARKE DAVIS
PFIZER
PFIZER
PFIZER
PFIZER
PFIZER
PFIZER
PRECISION DERMAT
PRECISION DERMAT
PRECISION DERMAT
TRIAX PHARMS
TRIAX PHARMS
AUROBINDO PHARMA
AUROBINDO PHARMA
AUROBINDO PHARMA
IMPAX LABS
IMPAX LABS
IMPAX LABS
RANBAXY
RANBAXY
RANBAXY
SUN PHARM INDS INC
SUN PHARM INDS INC
SUN PHARM INDS INC
TEVA
TEVA
TEVA
WATSON LABS
WATSON LABS
WATSON LABS
HIKMA PHARMS LLC
MOBAN
ENDO PHARMS
MOBAN
ENDO PHARMS
MOBAN
MODRASTANE
MODRASTANE
MONODOX
MONODOX
MONODOX
MYCOBUTIN
MYORISAN
MYORISAN
MYORISAN
NALFON
NALFON
NALFON
NAPROXEN SODIUM
NAVANE
NAVANE
NAVANE
NAVANE
NAVANE
NEMBUTAL SODIUM
NEMBUTAL SODIUM
NEMBUTAL SODIUM
NEORAL
NEORAL
NEORAL
NEURONTIN
NEURONTIN
NEURONTIN
NIFEDIPINE
NIFEDIPINE
NIFEDIPINE
NIFEDIPINE
NIFEDIPINE
NIFEDIPINE
NIFEDIPINE
NIFEDIPINE
NIFEDIPINE
NIFEDIPINE
NIMODIPINE
NIMODIPINE
ENDO PHARMS
BIOENVISION
BIOENVISION
AQUA PHARMS
AQUA PHARMS
AQUA PHARMS
ACCORD HLTHCARE
ALKEM LABS LTD
APOTEX CORP
DR REDDYS LABS LTD
MYLAN
ROXANE
SANDOZ
STRIDES PHARMA
TEVA PHARMS
VINTAGE PHARMS LLC
DOUGLAS PHARMS
DOUGLAS PHARMS
DOUGLAS PHARMS
XSPIRE
XSPIRE
XSPIRE
BANNER PHARMACAPS
PFIZER
PFIZER
PFIZER
PFIZER
PFIZER
OAK PHARMS
OAK PHARMS
OAK PHARMS
NOVARTIS
NOVARTIS
NOVARTIS
PFIZER PHARMS
PFIZER PHARMS
PFIZER PHARMS
ANI PHARMS INC
ANI PHARMS INC
ANI PHARMS INC
ANI PHARMS INC
EPIC PHARMA
EPIC PHARMA
MYLAN
MYLAN
WATSON LABS
WATSON LABS
ACTAVIS ELIZABETH
ACTAVIS ELIZABETH
CATALENT
CATALENT
CHASE LABS NJ
CHASE LABS NJ
EMCURE PHARMS USA
EMCURE PHARMS USA
INTERGEL PHARM
TEVA
BANNER PHARMACAPS
BARR LABS INC
Strength
200MG
500MG
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
0.5MG;EQ 1MG BASE
0.5MG;EQ 2MG BASE
0.5MG;EQ 5MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
0.6MG
30MG
60MG
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
150MG
250MG
250MG
250MG
250MG
250MG
250MG
250MG
250MG
250MG
250MG
250MG
10MG
20MG
40MG
EQ 200MG BASE
EQ 300MG BASE
EQ 400MG BASE
EQ 200MG BASE
1MG
2MG
5MG
10MG
20MG
30MG
50MG
100MG
25MG
50MG
100MG
100MG
300MG
400MG
20MG
20MG
30MG
30MG
20MG
30MG
20MG
30MG
20MG
30MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
20MG
10MG
10MG
30MG
30MG
Page 00077
Appl_Type
Approval_Date
RLD Type
Applicant_Full_Name
2‐Sep‐87
18‐Oct‐02
31‐May‐90
12‐Feb‐01
31‐May‐90
11‐Mar‐08
11‐Mar‐08
11‐Mar‐08
23‐Mar‐99
18‐Apr‐01
23‐Mar‐99
30‐Nov‐00
30‐Nov‐00
30‐Nov‐00
13‐May‐13
13‐May‐13
13‐May‐13
2‐Mar‐92
12‐Aug‐03
2‐Mar‐92
30‐Dec‐91
10‐Jun‐99
30‐Dec‐91
26‐Sep‐14
No
Yes
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
DISCN
OTC
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
RX
DISCN
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
PFIZER INC
PFIZER INC
PFIZER INC
PRECISION DERMATOLOGY INC
TRIAX PHARMACEUTICALS LLC
TRIAX PHARMACEUTICALS LLC
A
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
71002
21472
8855
17442
17442
17442
17986
17986
17986
50649
50649
50649
50315
50315
65470
65470
65470
65005
65005
65005
65062
65062
65062
90867
90867
90867
63011
63009
63009
63181
63065
63065
204820
1
1
4
2
3
1
1
2
3
1
3
2
2
1
1
2
3
1
3
2
1
2
3
1
2
3
1
2
1
1
2
1
1
N
17111
1
No
DISCN ENDO PHARMACEUTICALS INC
N
17111
2
No
DISCN ENDO PHARMACEUTICALS INC
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
N
N
A
A
A
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
17111
18719
18719
50641
50641
50641
50689
90253
200197
90419
91315
65520
65410
65379
90055
65491
90111
65433
76485
76485
76485
17604
17604
17604
21920
16584
16584
16584
16584
16584
84095
84093
83245
50715
50715
50715
20235
20235
20235
74439
74540
74439
74540
74928
74928
74642
74642
74670
74670
72579
72556
73250
74045
72409
73421
202644
202644
72781
72651
76740
77811
3
2
1
2
3
1
1
1
1
1
1
1
1
1
1
1
1
1
1
2
3
3
2
4
1
1
2
3
4
5
1
1
1
1
3
2
1
2
3
1
1
2
2
1
2
1
2
1
2
1
1
1
1
1
1
1
2
1
1
1
1
31‐Dec‐84
31‐Dec‐84
10‐Feb‐92
18‐Oct‐06
29‐Dec‐89
23‐Dec‐92
4‐May‐09
13‐Jun‐13
22‐Apr‐09
27‐Oct‐11
4‐May‐09
29‐Jul‐08
15‐Oct‐08
10‐Jun‐10
6‐May‐09
22‐Dec‐09
4‐May‐09
19‐Jan‐12
19‐Jan‐12
19‐Jan‐12
21‐Jul‐09
17‐Feb‐06
14‐Jul‐95
14‐Jul‐95
14‐Jul‐95
30‐Dec‐93
30‐Dec‐93
30‐Dec‐93
10‐Dec‐96
28‐Oct‐96
10‐Dec‐96
28‐Oct‐96
19‐Mar‐98
19‐Mar‐98
18‐Jul‐96
18‐Jul‐96
28‐Oct‐96
28‐Oct‐96
8‐Jan‐91
20‐Sep‐90
8‐Oct‐91
30‐Apr‐92
4‐Jul‐90
19‐Jun‐91
25‐Apr‐13
25‐Apr‐13
30‐Jul‐93
19‐Feb‐92
17‐Jan‐08
2‐May‐07
No
No
No
No
No
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
Yes
No
No
Yes
No
No
No
No
No
No
No
Yes
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
DISCN
RX
OTC
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
RX
RX
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB1
AB1
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
ENDO PHARMACEUTICALS INC
BIOENVISION INC
BIOENVISION INC
ACCORD HEALTHCARE INC
APOTEX CORP
SANDOZ INC
DOUGLAS PHARMACEUTICALS AMERICA LTD
XSPIRE LLC
XSPIRE LLC
XSPIRE LLC
PFIZER INC
PFIZER INC
PFIZER INC
PFIZER INC
PFIZER INC
OAK PHARMACEUTICALS INC
EPIC PHARMA INC
EPIC PHARMA INC
CATALENT PHARMA SOLUTIONS LLC
CHASE LABORATORIES INC
CHASE LABORATORIES INC
INTERGEL PHARMACEUTICAL INC
Page 00078
Ingredient
NIMODIPINE
NIMODIPINE
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
NIMODIPINE
NITROFURANTOIN
NITROFURANTOIN
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
METHYPRYLON
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
DROXIDOPA
DROXIDOPA
DROXIDOPA
RITONAVIR
RITONAVIR
LEVOPROPOXYPHENE NAPSYLATE ANHYDROUS
LEVOPROPOXYPHENE NAPSYLATE ANHYDROUS
DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
FLUOXETINE HYDROCHLORIDE; OLANZAPINE
SIMEPREVIR SODIUM
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00079
Trade_Name
NIMODIPINE
NIMODIPINE
Applicant
SUN PHARM INDS INC
NIMOTOP
NITROFURANTOIN
NITROFURANTOIN
NITROFURANTOIN
NITROFURANTOIN
NITROFURANTOIN
NITROFURANTOIN
NITROFURANTOIN
NITROFURANTOIN
NITROFURANTOIN
NITROFURANTOIN
NITROFURANTOIN
NITROFURANTOIN
NITROFURANTOIN
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
NITROFURANTOIN MACROCRYSTALLINE
NITROFURANTOIN MACROCRYSTALLINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NIZATIDINE
NOLUDAR
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
NORPACE
NORPACE
NORTHERA
NORTHERA
NORTHERA
NORVIR
NORVIR
NOVRAD
NOVRAD
NUEDEXTA
OBESTIN‐30
OBY‐TRIM
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
OLYSIO
BAYER PHARMS
MYLAN
MYLAN
MYLAN
SANDOZ
SANDOZ
SANDOZ
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
MYLAN
RANBAXY LABS LTD
SANDOZ
WATSON LABS
WATSON LABS
ANI PHARMS INC
ANI PHARMS INC
ANI PHARMS INC
ANI PHARMS INC
APOTEX INC
APOTEX INC
DR REDDYS LABS LTD
DR REDDYS LABS LTD
GLENMARK GENERICS
GLENMARK GENERICS
MYLAN PHARMS INC
MYLAN PHARMS INC
MYLAN PHARMS INC
MYLAN PHARMS INC
SANDOZ
SANDOZ
WATSON LABS
WATSON LABS
ROCHE
WARNER CHILCOTT
GD SEARLE LLC
GD SEARLE LLC
LUNDBECK NA LTD
LUNDBECK NA LTD
LUNDBECK NA LTD
MYLAN
MYLAN
MYLAN
MYLAN
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
TARO
TARO
TARO
TARO
TEVA
TEVA
TEVA
TEVA
TEVA
TEVA
TEVA
TEVA
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
ABBOTT
ABBVIE
LILLY
LILLY
AVANIR PHARMS
FERNDALE LABS
SHIRE RICHWOOD
PAR PHARM
PAR PHARM
PAR PHARM
PAR PHARM
PAR PHARM
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
JANSSEN PRODS
APOTEX INC
PAR PHARM INC
Strength
30MG
30MG
50MG
100MG
50MG
100MG
100MG
25MG
50MG
100MG
25MG
50MG
50MG
100MG
100MG
75MG;25MG
75MG;25MG
75MG;25MG
50MG
100MG
150MG
150MG
300MG
300MG
150MG
300MG
150MG
300MG
150MG
300MG
150MG
150MG
300MG
300MG
150MG
300MG
150MG
300MG
300MG
0.02MG;1MG
EQ 100MG BASE
EQ 150MG BASE
100MG
200MG
300MG
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 10MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 75MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 10MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 75MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
100MG
100MG
EQ 50MG BASE
EQ 100MG BASE
20MG;10MG
30MG
30MG
EQ 150MG BASE
Page 00080
Appl_Type
A
A
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
A
A
77067
1 AB
90103
1 AB
18869
73671
73652
74967
74967
77025
74336
74336
74336
73696
73696
84326
73696
84326
76648
76951
77066
70248
70249
75461
75668
75461
75668
76383
76383
77314
77314
90618
90618
75806
75934
75806
75934
76178
76178
75616
75616
9660
204426
17447
17447
203202
203202
203202
74234
74234
74234
74234
74054
74835
74054
74835
74054
74835
74054
74835
75520
75520
75520
75520
73667
74132
73667
74132
73667
74132
73667
74132
73553
73554
73555
73556
20680
20945
12928
12928
21879
87144
87764
77742
77742
77742
77742
77742
78901
78901
78901
78901
78901
202074
77528
77528
77528
77528
205123
90973
91018
1
1
1
1
2
1
1
2
3
1
2
1
3
2
1
1
1
1
1
1
1
2
2
1
2
1
2
1
2
1
1
2
2
1
2
1
2
8
1
1
2
1
2
3
1
2
3
4
1
1
2
2
3
3
4
4
4
3
1
2
1
1
2
2
3
3
4
4
1
1
1
1
1
1
6
4
1
1
1
1
2
3
4
5
5
1
3
2
4
1
1
2
3
4
1
1
1
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
Approval_Date
RLD Type
17‐Apr‐07 No RX
7‐Apr‐14 No RX
28‐Dec‐88
28‐Jan‐93
28‐Jan‐93
9‐Jul‐97
9‐Jul‐97
18‐Aug‐04
25‐Jan‐95
25‐Jan‐95
25‐Jan‐95
31‐Dec‐92
31‐Dec‐92
31‐Dec‐92
22‐Mar‐04
30‐Mar‐05
5‐Apr‐05
24‐Jun‐88
24‐Jun‐88
8‐Jul‐02
12‐Sep‐02
8‐Jul‐02
12‐Sep‐02
23‐Jan‐03
23‐Jan‐03
15‐Sep‐05
15‐Sep‐05
15‐Jul‐11
15‐Jul‐11
5‐Jul‐02
9‐Jul‐02
5‐Jul‐02
9‐Jul‐02
5‐Jul‐02
5‐Jul‐02
9‐Jul‐02
9‐Jul‐02
19‐Apr‐13
18‐Feb‐14
18‐Feb‐14
18‐Feb‐14
26‐Jul‐93
26‐Jul‐93
26‐Jul‐93
26‐Jul‐93
31‐Dec‐92
30‐Jun‐97
31‐Dec‐92
30‐Jun‐97
31‐Dec‐92
30‐Jun‐97
31‐Dec‐92
30‐Jun‐97
8‐May‐00
8‐May‐00
8‐May‐00
8‐May‐00
11‐Apr‐96
27‐Mar‐95
11‐Apr‐96
27‐Mar‐95
11‐Apr‐96
27‐Mar‐95
11‐Apr‐96
27‐Mar‐95
30‐Mar‐92
30‐Mar‐92
30‐Mar‐92
30‐Mar‐92
1‐Mar‐96
29‐Jun‐99
29‐Oct‐10
18‐Mar‐82
2‐Nov‐12
2‐Nov‐12
2‐Nov‐12
2‐Nov‐12
2‐Nov‐12
16‐Nov‐12
16‐Nov‐12
16‐Nov‐12
16‐Nov‐12
16‐Nov‐12
25‐Mar‐13
19‐Jun‐12
19‐Jun‐12
19‐Jun‐12
19‐Jun‐12
22‐Nov‐13
30‐Sep‐14
24‐Jun‐14
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
Yes
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
DISCN
RX
RX
RX
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
DISCN
DISCN
DISCN
RX
DISCN
RX
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
RX
DISCN
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
RX
DISCN
RX
DISCN
RX
DISCN
RX
RX
RX
RX
RX
DISCN
RX
DISCN
DISCN
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
Applicant_Full_Name
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
APOTEX INC
APOTEX INC
GLENMARK GENERICS INC USA
SANDOZ INC
SANDOZ INC
WARNER CHILCOTT CO INC
GD SEARLE LLC
GD SEARLE LLC
LUNDBECK NA LTD
LUNDBECK NA LTD
LUNDBECK NA LTD
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
TARO PHARMACEUTICALS INC
ABBVIE INC
ELI LILLY INDUSTRIES INC
ELI LILLY INDUSTRIES INC
AVANIR PHARMACEUTICALS INC
FERNDALE LABORATORIES INC
SHIRE RICHWOOD INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
JANSSEN PRODUCTS LP
APOTEX INC
Page 00081
Ingredient
OMEPRAZOLE; SODIUM BICARBONATE
CEFDINIR
DOXYCYCLINE
IPODATE SODIUM
NITISINONE
NITISINONE
NITISINONE
KETOPROFEN
KETOPROFEN
KETOPROFEN
OXACILLIN SODIUM
OXACILLIN SODIUM
OXACILLIN SODIUM
OXACILLIN SODIUM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
METHOXSALEN
OXYTETRACYCLINE HYDROCHLORIDE
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE
PARAMETHADIONE
PARAMETHADIONE
PARICALCITOL
PARICALCITOL
PARICALCITOL
PARICALCITOL
PARICALCITOL
PARICALCITOL
PARICALCITOL
PARICALCITOL
PARICALCITOL
PARICALCITOL
PARICALCITOL
PARICALCITOL
PAROMOMYCIN SULFATE
PAROMOMYCIN SULFATE
POTASSIUM AMINOSALICYLATE
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
PAROXETINE HYDROCHLORIDE
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
POTASSIUM PERCHLORATE
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00082
Trade_Name
OMEPRAZOLE AND SODIUM BICARBONATE
OMNICEF
OMNIPEN (AMPICILLIN)
OMTRYG
ONA‐MAST
ONA‐MAST
ORACEA
ORAGRAFIN SODIUM
ORFADIN
ORFADIN
ORFADIN
ORUDIS
ORUDIS
ORUDIS
OXACILLIN SODIUM
OXACILLIN SODIUM
OXACILLIN SODIUM
OXACILLIN SODIUM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXAZEPAM
OXSORALEN‐ULTRA
OXY‐KESSO‐TETRA
OXYCODONE AND ACETAMINOPHEN
PAMELOR
PAMELOR
PAMELOR
PAMELOR
PANMYCIN
PARADIONE
PARADIONE
PARICALCITOL
PARICALCITOL
PARICALCITOL
PARICALCITOL
PARICALCITOL
PARICALCITOL
PARICALCITOL
PARICALCITOL
PARICALCITOL
PARICALCITOL
PARICALCITOL
PARICALCITOL
PARLODEL
PAROMOMYCIN SULFATE
PAROMOMYCIN SULFATE
PASKALIUM
PATHOCIL
PATHOCIL
Applicant
TEVA PHARMS USA
PAR PHARM
PAR PHARM
ABBVIE
WYETH AYERST
WYETH AYERST
TRYGG
MAST MM
MAST MM
GALDERMA LABS LP
BRACCO
SWEDISH ORPHAN
SWEDISH ORPHAN
SWEDISH ORPHAN
WYETH AYERST
WYETH AYERST
WYETH AYERST
APOTHECON
APOTHECON
TEVA
TEVA
ACTAVIS ELIZABETH
ACTAVIS ELIZABETH
ACTAVIS ELIZABETH
AM THERAP
AM THERAP
AM THERAP
MUTUAL PHARM
MUTUAL PHARM
MUTUAL PHARM
MYLAN
MYLAN
MYLAN
SANDOZ
SANDOZ
SANDOZ
WATSON LABS
WATSON LABS
WATSON LABS
DOW PHARM
FERRANTE
ACTAVIS ELIZABETH
BARR
DURAMED PHARMS BARR
HALSEY
MALLINCKRODT
MUTUAL PHARM
VINTAGE PHARMS
VINTAGE PHARMS LLC
WATSON LABS
COASTAL PHARMS
LEHIGH VALLEY
HIKMA PHARMS LLC
IMPAX LABS
PROTER
PUREPAC PHARM
MALLINCKRODT LLC
MALLINCKRODT LLC
MALLINCKRODT LLC
MALLINCKRODT LLC
ABBVIE
ABBVIE
BANNER PHARMACAPS
BANNER PHARMACAPS
BANNER PHARMACAPS
DR REDDYS LABS LTD
DR REDDYS LABS LTD
DR REDDYS LABS LTD
RISING PHARMS INC
RISING PHARMS INC
RISING PHARMS INC
TEVA PHARMS USA
TEVA PHARMS USA
TEVA PHARMS USA
US PHARMS HOLDINGS I
HERITAGE PHARMS INC
SUN PHARM INDS INC
GLENWOOD
WYETH AYERST
WYETH AYERST
PAXIL
APOTEX TECHNOLOGIES
PAXIL
APOTEX TECHNOLOGIES
PAXIL
APOTEX TECHNOLOGIES
PAXIL
PENBRITIN
PENBRITIN
PERCHLORACAP
APOTEX TECHNOLOGIES
WYETH AYERST
WYETH AYERST
LANNETT
LANNETT
VITARINE
MALLINCKRODT
Strength
20MG;1.1GM
40MG;1.1GM
300MG
250MG
500MG
1.2GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA‐3 FATTY ACIDS
30MG
30MG
40MG
500MG
2MG
5MG
10MG
25MG
50MG
75MG
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
10MG
15MG
30MG
10MG
15MG
30MG
10MG
15MG
30MG
10MG
15MG
30MG
10MG
15MG
30MG
10MG
15MG
30MG
10MG
15MG
30MG
10MG
EQ 250MG BASE
500MG;5MG
500MG;5MG
500MG;5MG
500MG;5MG
500MG;5MG
500MG;5MG
500MG;5MG
500MG;5MG
500MG;5MG
5MG
5MG
5MG
EQ 250MG BASE
EQ 250MG BASE
EQ 250MG BASE
EQ 250MG BASE
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
250MG
150MG
300MG
1MCG
2MCG
4MCG
1MCG
2MCG
4MCG
1MCG
2MCG
4MCG
1MCG
2MCG
4MCG
EQ 5MG BASE
EQ 250MG BASE
EQ 250MG BASE
500MG
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
50MG
100MG
100MG
100MG
200MG
Page 00083
Appl_Type
A
A
A
N
A
A
N
A
A
N
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
A
A
A
A
A
A
A
A
A
A
A
A
N
A
A
A
A
N
N
N
N
A
N
N
A
A
A
A
A
A
A
A
A
A
A
A
N
A
A
N
N
N
N
91028
1 AB
78966
1 AB
78966
2 AB
50739
1
60624
1
60624
2
204977
1
86511
1
86516
1
50805
1
12967
1
21232
1
21232
2
21232
3
18754
1
18754
2
18754
3
61450
2
61450
1
62222
1
62222
2
72251
1 AB
72252
1 AB
72253
1 AB
71955
1
71956
1
71957
1
70943
1
70944
1
70945
1
71026
2
71026
3
71026
1
71713
1
71714
1
71715
1
71813
1 AB
71756
1 AB
71814
1 AB
72952
1
72953
1
72954
1
19600
1 AB
60179
1
40199
1
40304
1
40289
1
89994
1
40257
1
40219
1
40106
1
40303
1
40234
1
203107
1 AB
203823
1 AB
200534
1 AB
60770
1
60760
1
60869
1
60634
1
18013
1 AB
18013
2 AB
18013
4 AB
18013
3 AB
60347
1
6800
3
6800
1
202539
1 AB
202539
2 AB
202539
3 AB
91412
1 AB
91412
2 AB
91412
3 AB
202124
1 AB
202124
2 AB
202124
3 AB
90829
1 AB
90829
2 AB
90829
3 AB
17962
2 AB
65173
1 AA
64171
1 AA
9395
4
50011
2
50011
3
20885
1
Approval_Date
7‐Apr‐14
25‐May‐10
25‐May‐10
4‐Dec‐97
23‐Apr‐14
26‐May‐06
18‐Jan‐02
18‐Jan‐02
18‐Jan‐02
31‐Jul‐87
9‐Jan‐86
9‐Jan‐86
14‐Apr‐88
14‐Apr‐88
14‐Apr‐88
3‐Mar‐88
3‐Mar‐88
3‐Mar‐88
3‐Aug‐87
3‐Aug‐87
3‐Aug‐87
10‐Aug‐87
10‐Aug‐87
10‐Aug‐87
20‐Oct‐87
20‐Oct‐87
20‐Oct‐87
19‐Apr‐88
19‐Apr‐88
19‐Apr‐88
28‐Sep‐90
28‐Sep‐90
28‐Sep‐90
30‐Oct‐86
30‐Dec‐98
2‐Oct‐00
16‐Mar‐99
4‐May‐89
4‐Aug‐98
22‐Jan‐98
30‐Jul‐96
30‐Dec‐99
30‐Oct‐97
26‐Jul‐12
1‐Aug‐14
20‐Oct‐10
27‐Mar‐14
27‐Mar‐14
27‐Mar‐14
24‐Jun‐14
24‐Jun‐14
24‐Jun‐14
24‐Jun‐14
24‐Jun‐14
24‐Jun‐14
27‐Sep‐13
27‐Sep‐13
27‐Sep‐13
1‐Mar‐82
14‐Dec‐07
30‐Jun‐97
28‐Mar‐83
RLD
No
No
No
No
No
No
Yes
No
No
Yes
No
No
No
Yes
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
Yes
No
No
No
9‐Oct‐98 No
Type
RX
RX
RX
DISCN
DISCN
DISCN
RX
DISCN
DISCN
RX
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
Applicant_Full_Name
PAR PHARMACEUTICAL
PAR PHARMACEUTICAL
ABBVIE INC
TRYGG PHARMA INC
MM MAST AND CO
MM MAST AND CO
GALDERMA LABORATORIES LP
SWEDISH ORPHAN BIOVITRUM AB PUBL
SANDOZ INC
SANDOZ INC
SANDOZ INC
DOW PHARMACEUTICAL SCIENCES
JOHN J FERRANTE
HALSEY DRUG CO INC
COASTAL PHARMACEUTICALS
LEHIGH VALLEY TECHNOLOGIES INC
PROTER LABORATORY SPA
MALLINCKRODT LLC
MALLINCKRODT LLC
MALLINCKRODT LLC
MALLINCKRODT LLC
ABBVIE INC
ABBVIE INC
RISING PHARMACEUTICALS INC
US PHARMACEUTICALS HOLDINGS I LLC
GLENWOOD INC
DISCN APOTEX TECHNOLOGIES INC
N
20885
2
9‐Oct‐98 No
N
20885
3
9‐Oct‐98 No
N
A
A
A
A
A
A
N
20885
60908
60908
85937
85915
83284
83338
17551
4
1
2
1
1
1
1
1
9‐Oct‐98
No
No
No
No
No
No
No
No
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
APOTEX TECHNOLOGIES INC
LANNETT CO INC
LANNETT CO INC
MALLINCKRODT MEDICAL INC
Page 00084
Ingredient
DOXYCYCLINE HYCLATE
DESIPRAMINE HYDROCHLORIDE
DESIPRAMINE HYDROCHLORIDE
PHENYLBUTAZONE
PHENYLBUTAZONE
PHENYLBUTAZONE
PHENYLBUTAZONE
PHENYTOIN SODIUM
PHENYTOIN SODIUM
PHENYTOIN SODIUM
PHENYTOIN SODIUM
PHENYTOIN SODIUM
CALCIUM ACETATE
CALCIUM ACETATE
CALCIUM ACETATE
PIROXICAM
PIROXICAM
PIROXICAM
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00085
Trade_Name
PERIOSTAT
PERTOFRANE
PERTOFRANE
PFIZERPEN‐A
PFIZERPEN‐A
PHENAPHEN W/ CODEINE NO. 2
PHENAZINE
PHENAZINE
PHENAZINE
PHENYLBUTAZONE
PHENYLBUTAZONE
PHENYLBUTAZONE
PHENYLBUTAZONE
PHENYTEK
PHENYTEK
PHENYTEX
PHENYTOIN SODIUM
PHENYTOIN SODIUM
PHOSLO
PHOSLO
PHOSLO GELCAPS
PHRENILIN FORTE
PHRENILIN WITH CAFFEINE AND CODEINE
PIROXICAM
PIROXICAM
PIROXICAM
Applicant
COLLAGENEX
SANOFI AVENTIS US
SANOFI AVENTIS US
PFIZER
PFIZER
ROBINS AH
ROBINS AH
ROBINS AH
MAST MM
MAST MM
MAST MM
SANDOZ
SANDOZ
SANDOZ
SANDOZ
VITARINE
VITARINE
VITARINE
VITARINE
VITARINE
VITARINE
VITARINE
ROXANE
ABC HOLDING
ABLE
ABLE
ABLE
BARR
BARR
CAMALL
CAMALL
DURAMED PHARMS BARR
ELITE LABS
ELITE LABS
INVAGEN PHARMS
INVAGEN PHARMS
INVAGEN PHARMS
INVAGEN PHARMS
IVAX PHARMS
KEN LIFESCIENCE
KVK TECH
KVK TECH
KVK TECH
KVK TECH
LANNETT
LANNETT
LANNETT
MIKAH PHARMA
MIKAH PHARMA
MIKAH PHARMA
MIKAH PHARMA
MUTUAL PHARM
MUTUAL PHARM
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
TEVA
TEVA
TEVA
TEVA
TEVA
TEVA
TG UNITED INC
TG UNITED LABS
TG UNITED LABS
TG UNITED LABS
TG UNITED LABS
TG UNITED LABS
TG UNITED LABS
TG UNITED LABS
TG UNITED LABS
TG UNITED LABS
TG UNITED LABS
USL PHARMA
USL PHARMA
USL PHARMA
VITARINE
VITARINE
WATSON LABS
IVAX PHARMS
MUTUAL PHARM
SANDOZ
WATSON LABS
MYLAN
MYLAN
WATSON LABS
PHARMERAL
WATSON LABS
FRESENIUS MEDCL
FRESENIUS MEDCL
FRESENIUS MEDCL
VALEANT
VALEANT
CYCLE PHARMS LTD
CYCLE PHARMS LTD
EGIS
Strength
EQ 20MG BASE
25MG
50MG
EQ 250MG BASE
EQ 500MG BASE
325MG;15MG
325MG;30MG
325MG;60MG
35MG
35MG
35MG
35MG
35MG
35MG
35MG
35MG
35MG
35MG
35MG
35MG
35MG
35MG
10MG
30MG
15MG
30MG
30MG
15MG
30MG
15MG
30MG
30MG
15MG
30MG
15MG
30MG
30MG
37.5MG
30MG
37.5MG
15MG
30MG
30MG
37.5MG
15MG
30MG
30MG
37.5MG
15MG
30MG
30MG
37.5MG
30MG
37.5MG
15MG
30MG
30MG
30MG
30MG
37.5MG
30MG
30MG
30MG
30MG
30MG
30MG
30MG
18.75MG
30MG
30MG
30MG
37.5MG
37.5MG
37.5MG
37.5MG
37.5MG
37.5MG
30MG
30MG
30MG
30MG
30MG
30MG
100MG
100MG
100MG
100MG
200MG EXTENDED
300MG EXTENDED
100MG EXTENDED
100MG PROMPT
100MG PROMPT
EQ 84.5MG CALCIUM
EQ 169MG CALCIUM
EQ 169MG CALCIUM
650MG;50MG
10MG
20MG
10MG
Page 00086
Appl_Type
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
A
A
A
A
A
50744
1
13621
1
13621
2
62050
1
62050
2
84444
1
84445
1
84446
1
86523
1
86524
1
86525
1
85633
1
85694
1
85695
1
85702
1
85634
1
85645
1
85670
1
86403
1
86408
1
86410
1
87424
1
201050
1 AB
85411
1
40497
1
40403
1
40427
1
90591
1 AA
90591
2 AA
86735
1
87226
1
88948
1
202248
1 AA
202248
2 AA
202858
1 AA
202858
2 AA
204414
1 AA
202846
1 AA
86329
1
205017
1 AA
40886
2 AA
40875
1 AA
40886
1 AA
40887
1 AA
87022
2 AA
87022
1 AA
91359
1 AA
201961
1 AA
40460
1
40227
1
40448
1
40228
1
40525
1 AA
40527
1
87190
2 AA
86945
1 AA
87190
1 AA
87208
1
87223
1
88414
1
86911
1
87126
1
87777
1
88612
1
88613
1
88614
1
40083
1
88576
1
85417
1
86732
2
87215
1
87915
1
87918
1
87930
1
88610
1
88611
1
88625
1
84487
1
88430
1
88797
1
87202
1
87235
1
86740
1
88218
1
88994
1
87774
1
87756
1
40298
2 AB
40298
3 AB
88711
1
85435
1
85894
1
21160
1
21160
2
21160
3 AB
88831
1
74911
1
73651
1
73651
2
74808
1
Approval_Date
30‐Sep‐98
16‐Jul‐12
13‐Mar‐03
30‐Aug‐01
30‐Aug‐01
18‐Mar‐10
18‐Mar‐10
25‐Apr‐86
28‐Sep‐12
28‐Sep‐12
14‐Feb‐14
14‐Feb‐14
5‐May‐14
5‐Feb‐14
25‐Sep‐14
31‐Mar‐08
21‐Mar‐08
31‐Mar‐08
24‐Apr‐08
20‐Jan‐12
3‐Feb‐83
16‐Jul‐10
20‐Jul‐11
14‐Jan‐03
18‐Jun‐97
22‐Jan‐03
19‐Jun‐97
23‐Oct‐03
23‐Oct‐03
20‐Jul‐83
19‐Oct‐83
1‐Nov‐85
4‐Apr‐84
9‐Apr‐84
9‐Apr‐84
7‐Mar‐97
23‐May‐84
22‐Dec‐83
22‐Dec‐83
14‐Oct‐83
4‐Jun‐84
4‐Jun‐84
23‐Aug‐84
9‐Apr‐82
27‐Mar‐84
10‐Dec‐84
21‐Mar‐85
24‐Jun‐83
4‐Dec‐85
16‐Jun‐82
17‐Dec‐82
6‐Dec‐01
6‐Dec‐01
21‐Dec‐84
2‐Apr‐01
2‐Apr‐01
2‐Apr‐01
19‐Jun‐85
22‐Aug‐01
26‐Feb‐93
26‐Feb‐93
8‐Jul‐97
RLD
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
Yes
No
No
No
No
No
Type
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
Applicant_Full_Name
COLLAGENEX INC
AH ROBINS CO
AH ROBINS CO
AH ROBINS CO
MM MAST AND CO
MM MAST AND CO
MM MAST AND CO
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
ABC HOLDING CORP
CAMALL CO INC
CAMALL CO INC
ELITE LABORATORIES INC
ELITE LABORATORIES INC
KEN LIFESCIENCE
KVK TECH INC
KVK TECH INC
KVK TECH INC
KVK TECH INC
LANNETT CO INC
LANNETT CO INC
MIKAH PHARMA LLC
MIKAH PHARMA LLC
MIKAH PHARMA LLC
MIKAH PHARMA LLC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
TG UNITED INC
TG UNITED LABS LLC
TG UNITED LABS LLC
TG UNITED LABS LLC
TG UNITED LABS LLC
TG UNITED LABS LLC
TG UNITED LABS LLC
TG UNITED LABS LLC
TG UNITED LABS LLC
TG UNITED LABS LLC
TG UNITED LABS LLC
USL PHARMA INC
USL PHARMA INC
USL PHARMA INC
SANDOZ INC
PHARMERAL INC
FRESENIUS MEDICAL CARE NORTH AMERICA
EGIS PHARMACEUTICALS
Page 00087
Ingredient
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
ETHCHLORVYNOL
ETHCHLORVYNOL
ETHCHLORVYNOL
ETHCHLORVYNOL
POMALIDOMIDE
POMALIDOMIDE
POMALIDOMIDE
POMALIDOMIDE
MEFENAMIC ACID
DABIGATRAN ETEXILATE MESYLATE
DABIGATRAN ETEXILATE MESYLATE
PRAZEPAM
PRAZEPAM
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
AMPICILLIN/AMPICILLIN TRIHYDRATE; PROBENECID
PROCAINAMIDE HYDROCHLORIDE
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00088
Trade_Name
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PIROXICAM
PLACIDYL
PLACIDYL
PLACIDYL
PLACIDYL
POLYCILLIN
POLYCILLIN
POMALYST
POMALYST
POMALYST
POMALYST
PONSTEL
PRADAXA
PRADAXA
PRAZEPAM
PRAZEPAM
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PREGABALIN
PRINCIPEN
PRINCIPEN
PRINCIPEN
PRINCIPEN
PRINCIPEN '250'
PRINCIPEN '250'
PRINCIPEN '500'
PRINCIPEN '500'
PRINCIPEN W/ PROBENECID
PRINCIPEN W/ PROBENECID
Applicant
EGIS
MUTUAL PHARM
MUTUAL PHARM
MYLAN
MYLAN
MYLAN
MYLAN
NOSTRUM LABS
NOSTRUM LABS
SCS
SCS
TEVA
TEVA
TEVA
TEVA
TEVA PHARMS
TEVA PHARMS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
ABBVIE
ABBVIE
ABBVIE
ABBVIE
BRISTOL
BRISTOL
CELGENE
CELGENE
CELGENE
CELGENE
SHIONOGI INC
USL PHARMA
USL PHARMA
AM THERAP
AM THERAP
AM THERAP
CLONMEL HLTHCARE
CLONMEL HLTHCARE
CLONMEL HLTHCARE
MYLAN
MYLAN
MYLAN
PUREPAC PHARM
PUREPAC PHARM
PUREPAC PHARM
SANDOZ
SANDOZ
SANDOZ
TEVA PHARMS
TEVA PHARMS
WATSON LABS
WATSON LABS
WATSON LABS
LUPIN LTD
LUPIN LTD
LUPIN LTD
LUPIN LTD
LUPIN LTD
LUPIN LTD
LUPIN LTD
LUPIN LTD
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
ASCOT
ASCOT
ASCOT
LANNETT
Strength
20MG
10MG
20MG
10MG
20MG
10MG
10MG
20MG
20MG
10MG
20MG
10MG
20MG
10MG
10MG
20MG
20MG
10MG
20MG
10MG
10MG
20MG
20MG
100MG
200MG
500MG
750MG
EQ 250MG BASE
EQ 500MG BASE
1MG
2MG
3MG
4MG
250MG
EQ 75MG BASE
EQ 150MG BASE
5MG
10MG
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 1MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
25MG
50MG
75MG
100MG
150MG
200MG
225MG
300MG
25MG
50MG
75MG
100MG
150MG
200MG
225MG
300MG
25MG
50MG
75MG
100MG
150MG
200MG
225MG
300MG
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 250MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 500MG BASE
EQ 389MG BASE;111MG
EQ 389MG BASE;111MG
250MG
375MG
500MG
250MG
375MG
500MG
250MG
Page 00089
Appl_Type
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
A
N
A
N
A
A
A
A
A
A
A
74808
2
74148
1
74148
2
73535
1 AB
73536
1
74043
1
74102
1 AB
74043
2
74102
2 AB
74116
1 AB
74118
1 AB
74036
1
74036
2
73637
1
74131
1 AB
73638
1
74131
2 AB
74103
1
74103
2
74287
1
74460
1
74287
2
74460
2
10021
4
10021
7
10021
2
10021
10
50310
1
50310
2
204026
1
204026
2
204026
3
204026
4
15034
3 AB
22512
1
22512
2
70427
1
70428
1
72782
1
72783
1
72784
1
72705
1
72706
1
72707
1
71994
1 AB
72575
3 AB
72575
2 AB
72575
1 AB
72991
1
72921
1
72992
1
72576
1
72577
1
72578
1
71995
1 AB
71745
1 AB
72352
1
72333
1
72609
1
91040
1 AB
91040
2 AB
91040
3 AB
91040
4 AB
91040
5 AB
91040
6 AB
91040
7 AB
91040
8 AB
91219
1 AB
91219
2 AB
91224
1 AB
91224
2 AB
91224
3 AB
91224
4 AB
91224
5 AB
91224
6 AB
91221
1 AB
91221
2 AB
91221
3 AB
91221
4 AB
91221
5 AB
91221
6 AB
91221
7 AB
91221
8 AB
62888
1
62888
2
61392
1
61392
2
62157
2
50056
1
62157
1
50056
2
62150
1
50488
1
87542
1
87697
1
87543
1
84604
1
84595
1
84606
1
83693
1
Approval_Date
8‐Jul‐97
3‐Jun‐96
3‐Jun‐96
12‐Mar‐93
12‐Mar‐93
22‐Sep‐92
31‐Jul‐92
22‐Sep‐92
31‐Jul‐92
15‐Jun‐93
15‐Jun‐93
29‐May‐92
29‐May‐92
28‐Jan‐94
11‐Dec‐92
28‐Jan‐94
11‐Dec‐92
28‐Aug‐92
28‐Aug‐92
16‐May‐96
29‐Sep‐95
16‐May‐96
29‐Sep‐95
8‐Feb‐13
8‐Feb‐13
8‐Feb‐13
8‐Feb‐13
19‐Oct‐10
19‐Oct‐10
6‐Nov‐87
6‐Nov‐87
16‐May‐89
16‐May‐89
16‐May‐89
16‐May‐89
16‐May‐89
16‐May‐89
12‐Sep‐88
16‐May‐89
16‐May‐89
16‐May‐89
16‐May‐89
16‐May‐89
16‐May‐89
16‐May‐89
16‐May‐89
16‐May‐89
12‐Sep‐88
12‐Sep‐88
16‐May‐89
16‐May‐89
16‐May‐89
3‐Jul‐12
3‐Jul‐12
3‐Jul‐12
3‐Jul‐12
3‐Jul‐12
3‐Jul‐12
3‐Jul‐12
3‐Jul‐12
3‐Jul‐12
3‐Jul‐12
3‐Jul‐12
3‐Jul‐12
3‐Jul‐12
3‐Jul‐12
3‐Jul‐12
3‐Jul‐12
3‐Jul‐12
3‐Jul‐12
3‐Jul‐12
3‐Jul‐12
3‐Jul‐12
3‐Jul‐12
3‐Jul‐12
3‐Jul‐12
4‐Mar‐88
4‐Mar‐88
8‐Jan‐82
1‐Mar‐83
8‐Jan‐82
RLD
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Type
DISCN
DISCN
DISCN
RX
DISCN
DISCN
RX
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
RX
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
Applicant_Full_Name
EGIS PHARMACEUTICALS
NOSTRUM LABORATORIES INC
NOSTRUM LABORATORIES INC
SCS PHARMACEUTICALS
SCS PHARMACEUTICALS
ABBVIE INC
ABBVIE INC
ABBVIE INC
ABBVIE INC
CELGENE CORP
CELGENE CORP
CELGENE CORP
CELGENE CORP
SHIONOGI INC
USL PHARMA INC
USL PHARMA INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
LUPIN LTD
LUPIN LTD
LUPIN LTD
LUPIN LTD
LUPIN LTD
LUPIN LTD
LUPIN LTD
LUPIN LTD
APOTHECON SUB BRISTOL MYERS SQUIBB CO
LANNETT CO INC
Page 00090
Ingredient
NIFEDIPINE
NIFEDIPINE
PROGESTERONE
PROGESTERONE
PROGESTERONE
PROGESTERONE
PROGESTERONE
PROGESTERONE
DIAZOXIDE
DIAZOXIDE
TACROLIMUS
TACROLIMUS
TACROLIMUS
PROGESTERONE
PROGESTERONE
PROGESTERONE
PHENYTOIN SODIUM
PHENYTOIN SODIUM
OXACILLIN SODIUM
BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE
UREA, C‐14
UREA, C‐14
QUININE SULFATE
CLIDINIUM BROMIDE
CLIDINIUM BROMIDE
QUINIDINE SULFATE
QUININE SULFATE
QUININE SULFATE
FERRIC HEXACYANOFERRATE(II)
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00091
Trade_Name
PROCAN
PROCAN
PROCAN
PROCAPAN
PROCARDIA
PROCARDIA
PROGESTERONE
PROGESTERONE
PROGESTERONE
PROGESTERONE
PROGESTERONE
PROGESTERONE
PROGLYCEM
PROGLYCEM
PROGRAF
PROGRAF
PROGRAF
PROMETRIUM
PROMETRIUM
PROMETRIUM
PROMPT PHENYTOIN SODIUM
PROMPT PHENYTOIN SODIUM
PRONESTYL
PRONESTYL
PRONESTYL
PROPHENE 65
PROPOXYPHENE COMPOUND 65
PROPOXYPHENE COMPOUND‐65
PROPOXYPHENE HYDROCHLORIDE 65
PROPOXYPHENE HYDROCHLORIDE W/ ASPIRIN AND CAFFEINE
PROSTAPHLIN
PROVAL #3
PROZAC
PROZAC
PROZAC
PROZAC
PYLERA
PYTEST
PYTEST KIT
QUALAQUIN
QUARZAN
QUARZAN
QUINIDINE SULFATE
QUININE SULFATE
QUININE SULFATE
RADIOGARDASE (PRUSSIAN BLUE)
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
Applicant
LANNETT
LEDERLE
LEDERLE
LEDERLE
ROXANE
ROXANE
SANDOZ
SANDOZ
SANDOZ
VANGARD
VANGARD
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
PARKE DAVIS
PARKE DAVIS
PARKE DAVIS
PANRAY
PFIZER
PFIZER
BANNER PHARMACAPS
BANNER PHARMACAPS
SOFGEN PHARMS
SOFGEN PHARMS
TEVA PHARMS
TEVA PHARMS
TEVA BRANDED PHARM
TEVA BRANDED PHARM
ASTELLAS
ASTELLAS
ASTELLAS
ABBVIE INC
ABBVIE INC
ABBVIE INC
ANI PHARMS INC
WATSON LABS
APOTHECON
APOTHECON
APOTHECON
HALSEY
SANDOZ
TEVA
SANDOZ
ALRA
IMPAX LABS
MUTUAL PHARM
MYLAN
MYLAN
MYLAN
NEXGEN PHARMA INC
PAR PHARM
PUREPAC PHARM
PVT FORM
PVT FORM
ROXANE
ROXANE
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
TEVA
VALEANT PHARM INTL
VINTAGE PHARMS
WATSON LABS
WATSON LABS
WEST WARD
WARNER CHILCOTT
WATSON LABS
APOTHECON
SOLVAY
ELI LILLY AND CO
ELI LILLY AND CO
ELI LILLY AND CO
ELI LILLY AND CO
FOREST LABS INC
AVENT
AVENT
MUTUAL PHARM CO INC
ROCHE
ROCHE
LILLY
MYLAN PHARMS INC
TEVA PHARMS
HEYL CHEMISCH
ACCORD HLTHCARE INC
ACCORD HLTHCARE INC
ACCORD HLTHCARE INC
ACCORD HLTHCARE INC
ACTAVIS ELIZABETH
ACTAVIS ELIZABETH
ACTAVIS ELIZABETH
Strength
500MG
250MG
375MG
500MG
250MG
500MG
250MG
375MG
500MG
250MG
500MG
250MG
250MG
250MG
375MG
375MG
500MG
500MG
500MG
250MG
375MG
500MG
250MG
10MG
20MG
100MG
200MG
100MG
200MG
100MG
200MG
50MG
100MG
EQ 0.5MG BASE
EQ 1MG BASE
EQ 5MG BASE
100MG
200MG
300MG
100MG PROMPT
100MG PROMPT
250MG
375MG
500MG
65MG
389MG;32.4MG;65MG
389MG;32.4MG;65MG
389MG;32.4MG;65MG
389MG;32.4MG;65MG
65MG
65MG
32MG
65MG
32MG
65MG
65MG
65MG
65MG
65MG
32MG
65MG
32MG
65MG
32MG
65MG
65MG
65MG
65MG
65MG
65MG
65MG
65MG
65MG
65MG
65MG
65MG
389MG;32.4MG;65MG
EQ 500MG BASE
325MG;30MG
EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
EQ 60MG BASE
140MG;125MG;125MG
1uCi
1uCi
324MG
2.5MG
5MG
200MG
324MG
324MG
500MG
1.25MG
2.5MG
5MG
10MG
1.25MG
2.5MG
5MG
Page 00092
Appl_Type
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
A
A
A
A
A
A
N
N
N
N
N
N
N
N
A
A
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
A
N
N
N
N
N
N
N
N
N
N
A
A
A
N
A
A
A
A
A
A
A
84696
1
86942
1
86952
1
86943
1
88989
1
88990
1
89219
1
89220
1
89221
1
87643
1
87875
1
83287
1
83795
1
85167
1
84403
1
87020
1
84280
1
84357
1
87021
1
85804
1
87502
1
85079
1
83553
2
18482
1 AB
18482
2
200900
1 AB
200900
2 AB
200456
1 AB
200456
2 AB
202121
1 AB
202121
2 AB
17425
1
17425
2
50708
3 AB
50708
1 AB
50708
2 AB
19781
1 AB
19781
2 AB
19781
3
80259
1
80905
1
7335
1
7335
4
7335
3
83538
2
83077
2
80044
2
89025
1
83101
2
83184
1
83317
1
83597
1
83186
1
83528
1
40569
1
83299
1
83185
1
80269
1
83278
1
83464
1
83113
1
83089
1
83089
2
84014
1
83125
2
83688
1
83870
2
86495
1
88615
1
80783
1
40908
1
80908
2
85190
1
83501
1
84551
1
83786
1
85732
2
50118
2
85685
1
18936
6 AB1
18936
1 AB1
18936
3 AB
18936
4
50786
1
20617
1
20617
2
21799
1 AB
10355
1
10355
2
85103
1
202581
1 AB
91661
1 AB
21626
1
202392
1 AB
202392
2 AB
202392
3 AB
202392
4 AB
77513
1
77513
2
77513
3
Approval_Date
26‐Apr‐85
26‐Apr‐85
1‐Jul‐86
1‐Jul‐86
1‐Jul‐86
1‐Jun‐82
1‐Jun‐82
24‐Jul‐86
16‐Aug‐13
16‐Aug‐13
28‐Sep‐12
28‐Sep‐12
29‐Feb‐12
29‐Feb‐12
24‐Aug‐98
8‐Apr‐94
8‐Apr‐94
14‐May‐98
15‐Oct‐99
15‐Oct‐99
7‐Dec‐84
16‐Sep‐83
29‐Mar‐85
24‐Jun‐85
16‐Dec‐04
22‐Oct‐84
17‐Jul‐09
3‐Sep‐84
23‐Dec‐92
29‐Dec‐87
15‐Jun‐99
15‐Jun‐99
28‐Sep‐06
9‐May‐97
9‐May‐97
12‐Aug‐05
14‐Dec‐12
28‐Sep‐12
2‐Oct‐03
15‐Apr‐14
15‐Apr‐14
15‐Apr‐14
15‐Apr‐14
18‐Jun‐08
18‐Jun‐08
18‐Jun‐08
RLD
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
Yes
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
Yes
Yes
Yes
Yes
No
No
No
No
No
Yes
No
No
No
No
No
No
No
Type
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
Applicant_Full_Name
LANNETT CO INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
PFIZER INC
PFIZER INC
SOFGEN PHARMACEUTICALS LLC
SOFGEN PHARMACEUTICALS LLC
ABBVIE INC
ABBVIE INC
ABBVIE INC
HALSEY DRUG CO INC
SANDOZ INC
SANDOZ INC
NEXGEN PHARMA INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
WEST WARD PHARMACEUTICAL CORP
ELI LILLY AND CO
ELI LILLY AND CO
ELI LILLY AND CO
ELI LILLY AND CO
AVENT INC
AVENT INC
ELI LILLY AND CO
HEYL CHEMISCH PHARMAZEUTISHE FABRIK
ACCORD HEALTHCARE INC USA
Page 00093
Ingredient
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RANITIDINE HYDROCHLORIDE
SILODOSIN
SILODOSIN
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
RIBAVIRIN
RIBAVIRIN
SEVELAMER HYDROCHLORIDE
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
ZIDOVUDINE
LENALIDOMIDE
LENALIDOMIDE
LENALIDOMIDE
LENALIDOMIDE
LENALIDOMIDE
LENALIDOMIDE
ATAZANAVIR SULFATE
ATAZANAVIR SULFATE
ATAZANAVIR SULFATE
ATAZANAVIR SULFATE
RIBAVIRIN
RIBAVIRIN
RIBAVIRIN
RIBAVIRIN
RIBAVIRIN
AURANOFIN
RIFABUTIN
RIFAMPIN
RIFAMPIN
ISONIAZID; RIFAMPIN
RIFAMPIN
RIFAMPIN
RIFAMPIN
RIFAMPIN
RIFAMPIN
RIFAMPIN
RIFAMPIN
RIFAMPIN
ISONIAZID; RIFAMPIN
RIFAMPIN
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00094
Trade_Name
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAMIPRIL
RAPAFLO
RAPAFLO
Applicant
ACTAVIS ELIZABETH
APOTEX
APOTEX
APOTEX
APOTEX
CIPLA
CIPLA
CIPLA
CIPLA
DR REDDYS LABS LTD
DR REDDYS LABS LTD
DR REDDYS LABS LTD
DR REDDYS LABS LTD
INVAGEN PHARMS
INVAGEN PHARMS
INVAGEN PHARMS
INVAGEN PHARMS
LUPIN
LUPIN
LUPIN
LUPIN
RANBAXY LABS LTD
RANBAXY LABS LTD
ROXANE
ROXANE
ROXANE
ROXANE
SANDOZ
SANDOZ
SANDOZ
SANDOZ
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
ZYDUS PHARMS USA
ZYDUS PHARMS USA
ZYDUS PHARMS USA
ZYDUS PHARMS USA
DR REDDYS LABS LTD
DR REDDYS LABS LTD
MYLAN
MYLAN
SANDOZ
SANDOZ
TEVA
TEVA
WATSON LABS
WATSON LABS
REBETOL
REBETOL
RENAGEL
RESTORIL
RESTORIL
RESTORIL
RESTORIL
RETET
RETET
RETROVIR
REVLIMID
REVLIMID
REVLIMID
REVLIMID
REVLIMID
REVLIMID
REYATAZ
REYATAZ
REYATAZ
REYATAZ
RIBASPHERE
RIBAVARIN
RIBAVIRIN
RIBAVIRIN
RIBAVIRIN
RIDAURA
RIFABUTIN
RIFADIN
RIFADIN
RIFAMATE
RIFAMPIN
RIFAMPIN
RIFAMPIN
RIFAMPIN
RIFAMPIN
RIFAMPIN
RIFAMPIN
RIFAMPIN
RIFAMPIN AND ISONIAZID
RIMACTANE
MERCK SHARP DOHME
MERCK SHARP DOHME
GENZYME
MALLINCKRODT INC
MALLINCKRODT INC
MALLINCKRODT INC
MALLINCKRODT INC
SOLVAY
SOLVAY
VIIV HLTHCARE
CELGENE
CELGENE
CELGENE
CELGENE
CELGENE
CELGENE
THREE RIVERS PHARMS
AUROBINDO PHARMA
SANDOZ
TEVA
ZYDUS PHARMS USA
PROMETHEUS LABS
LUPIN LTD
SANOFI AVENTIS US
SANOFI AVENTIS US
SANOFI AVENTIS US
LANNETT
LANNETT
LUPIN PHARMS
LUPIN PHARMS
SANDOZ
SANDOZ
VERSAPHARM
VERSAPHARM
HIKMA INTL PHARMS
PROSAM LABS
ALEMBIC PHARMS LTD
ALEMBIC PHARMS LTD
Strength
10MG
1.25MG
2.5MG
5MG
10MG
1.25MG
2.5MG
5MG
10MG
1.25MG
2.5MG
5MG
10MG
1.25MG
2.5MG
5MG
10MG
1.25MG
2.5MG
5MG
10MG
1.25MG
2.5MG
5MG
10MG
5MG
10MG
1.25MG
2.5MG
5MG
10MG
1.25MG
2.5MG
5MG
10MG
1.25MG
2.5MG
5MG
10MG
1.25MG
2.5MG
5MG
10MG
1.25MG
2.5MG
5MG
10MG
EQ 150MG BASE
EQ 300MG BASE
EQ 150MG BASE
EQ 300MG BASE
EQ 150MG BASE
EQ 300MG BASE
EQ 150MG BASE
EQ 300MG BASE
4MG
8MG
200MG **Indicated for use and comarketed with Interferon ALFA‐2B, Recombinant (INTRON A), as Rebetron Combination Therapy**
200MG
403MG
7.5MG
15MG
22.5MG
30MG
250MG
500MG
100MG
2.5MG
5MG
10MG
15MG
20MG
25MG
EQ 100MG BASE
EQ 150MG BASE
EQ 200MG BASE
EQ 300MG BASE
200MG
200MG
200MG
200MG
200MG
3MG
150MG
150MG
300MG
150MG;300MG
150MG
300MG
150MG
300MG
150MG
300MG
150MG
300MG
150MG;300MG
300MG
EQ 1.5MG BASE
EQ 3MG BASE
Page 00095
Appl_Type
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
N
N
A
A
N
N
N
N
N
N
N
N
N
N
N
A
A
A
A
A
N
A
A
N
A
A
A
A
A
A
A
A
A
A
N
A
A
77513
4
79116
1 AB
79116
2 AB
79116
3 AB
79116
4 AB
91604
1 AB
91604
2 AB
91604
3 AB
91604
4 AB
77004
1
77004
2
77004
3
77004
4
78191
1 AB
78191
2 AB
78191
3 AB
78191
4 AB
78745
1 AB
78745
2 AB
78745
3 AB
78745
4 AB
77626
1 AB
77626
2 AB
77626
3 AB
77626
4 AB
78849
1
78849
2
77900
1 AB
77900
2 AB
77900
3 AB
77900
4 AB
77514
1 AB
77514
2 AB
77514
3 AB
77514
4 AB
77470
1 AB
77470
2 AB
77470
3 AB
77470
4 AB
76549
1 AB
76549
2 AB
76549
3 AB
76549
4 AB
78832
1 AB
78832
2 AB
78832
3 AB
78832
4 AB
75742
1 AB
75742
2 AB
75564
1
75564
2
74655
1 AB
74655
2 AB
75557
1
75557
2
22206
1
22206
2
20903
20903
20926
18163
18163
18163
18163
61443
61443
19655
21880
21880
21880
21880
21880
21880
21567
21567
21567
21567
76203
79117
76192
76277
77224
18689
90033
62303
50420
61884
65390
65390
90034
90034
64150
64150
65028
65028
65221
50429
91689
91689
1
2
1
3
1
4
2
1
2
1
5
1
2
3
6
4
1
2
3
4
1
1
1
1
1
1
1
1
1
1
1
2
1
2
2
1
1
2
1
1
1
2
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
Approval_Date
18‐Jun‐08
20‐Jun‐08
20‐Jun‐08
20‐Jun‐08
20‐Jun‐08
8‐Jun‐11
8‐Jun‐11
8‐Jun‐11
8‐Jun‐11
7‐Aug‐08
7‐Aug‐08
7‐Aug‐08
7‐Aug‐08
18‐Jun‐08
18‐Jun‐08
18‐Jun‐08
18‐Jun‐08
18‐Jun‐08
18‐Jun‐08
18‐Jun‐08
18‐Jun‐08
9‐Jun‐08
9‐Jun‐08
9‐Jun‐08
9‐Jun‐08
6‐Mar‐09
6‐Mar‐09
18‐Jun‐08
18‐Jun‐08
18‐Jun‐08
18‐Jun‐08
18‐Jun‐08
18‐Jun‐08
18‐Jun‐08
18‐Jun‐08
18‐Jun‐08
18‐Jun‐08
18‐Jun‐08
18‐Jun‐08
24‐Oct‐05
24‐Oct‐05
24‐Oct‐05
24‐Oct‐05
2‐Sep‐08
2‐Sep‐08
2‐Sep‐08
2‐Sep‐08
29‐Nov‐00
29‐Nov‐00
27‐Oct‐00
27‐Oct‐00
22‐Oct‐97
22‐Oct‐97
31‐Oct‐03
31‐Oct‐03
8‐Oct‐08
8‐Oct‐08
RLD
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
Yes
No
Type
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
DISCN
DISCN
RX
RX
Applicant_Full_Name
APOTEX INC
APOTEX INC
APOTEX INC
APOTEX INC
CIPLA LTD
CIPLA LTD
CIPLA LTD
CIPLA LTD
LUPIN LTD
LUPIN LTD
LUPIN LTD
LUPIN LTD
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
3‐Jun‐98
25‐Jul‐01
30‐Oct‐98
25‐Oct‐91
2‐Nov‐04
19‐Mar‐87
21‐Dec‐11
27‐Dec‐05
27‐Dec‐05
29‐Jun‐06
5‐Jun‐13
29‐Jun‐06
20‐Jun‐03
20‐Jun‐03
20‐Jun‐03
16‐Oct‐06
6‐Apr‐04
17‐Sep‐09
6‐Apr‐04
4‐Oct‐04
28‐Oct‐05
24‐May‐85
24‐Feb‐14
28‐Mar‐08
28‐Mar‐08
21‐Aug‐13
21‐Aug‐13
2‐Jan‐98
28‐May‐97
14‐Mar‐01
14‐Mar‐01
29‐Jul‐05
12‐Jun‐12
12‐Jun‐12
Yes
Yes
No
No
No
No
Yes
No
No
Yes
No
No
No
No
No
Yes
No
No
No
Yes
No
No
No
No
No
Yes
No
No
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
RX
RX
DISCN
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
GENZYME CORP
MALLINCKRODT INC
MALLINCKRODT INC
MALLINCKRODT INC
MALLINCKRODT INC
VIIV HEALTHCARE CO
CELGENE CORP
CELGENE CORP
CELGENE CORP
CELGENE CORP
CELGENE CORP
CELGENE CORP
THREE RIVERS PHARMACEUTICALS LLC
SANDOZ INC
PROMETHEUS LABORATORIES INC
LUPIN LTD
SANDOZ INC
SANDOZ INC
VERSAPHARM INC
VERSAPHARM INC
PROSAM LABS LLC
Page 00096
Ingredient
CALCITRIOL
CALCITRIOL
METHACYCLINE HYDROCHLORIDE
METHACYCLINE HYDROCHLORIDE
CYANOCOBALAMIN CO‐57
CYANOCOBALAMIN CO‐60
CYCLOSPORINE
CYCLOSPORINE
CYCLOSPORINE
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE
OXAZEPAM
OXAZEPAM
OXAZEPAM
CYCLOSERINE
BETA CAROTENE
CARISOPRODOL
THEOPHYLLINE
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00097
Trade_Name
ROBITET
ROBITET
ROCALTROL
ROCALTROL
RONDOMYCIN
RONDOMYCIN
ROXILOX
RUBRATOPE‐57
RUBRATOPE‐60
SANDIMMUNE
SANDIMMUNE
SANDIMMUNE
SARAFEM
SARAFEM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECOBARBITAL SODIUM
SECONAL SODIUM
SECONAL SODIUM
SECTRAL
SECTRAL
SEMPREX‐D
SERAX
SERAX
SERAX
SEROMYCIN
SINEQUAN
SINEQUAN
SINEQUAN
SINEQUAN
SINEQUAN
SINEQUAN
SODIUM IODIDE I 123
SODIUM IODIDE I 123
SODIUM IODIDE I 123
SODIUM IODIDE I 123
SODIUM IODIDE I 123
SODIUM IODIDE I 123
SODIUM IODIDE I 131
SODIUM IODIDE I 131
SODIUM IODIDE I 131
SODIUM IODIDE I 131
SODIUM IODIDE I 131
SODIUM PENTOBARBITAL
SOLATENE
SOMA
SOMOPHYLLIN‐T
Applicant
ALEMBIC PHARMS LTD
ALEMBIC PHARMS LTD
APOTEX INC
APOTEX INC
APOTEX INC
APOTEX INC
DR REDDYS LABS INC
DR REDDYS LABS INC
DR REDDYS LABS INC
DR REDDYS LABS INC
MACLEODS PHARMS LTD
MACLEODS PHARMS LTD
MACLEODS PHARMS LTD
MACLEODS PHARMS LTD
SUN PHARM INDS
SUN PHARM INDS
SUN PHARM INDS
SUN PHARM INDS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WYETH AYERST
WYETH AYERST
VALIDUS PHARMS
VALIDUS PHARMS
MEDPOINTE PHARM HLC
MEDPOINTE PHARM HLC
ROXANE
BRACCO
BRACCO
NOVARTIS
NOVARTIS
NOVARTIS
ELI LILLY AND CO
ELI LILLY AND CO
ANABOLIC
BARR
EVERYLIFE
HALSEY
IVAX PHARMS
KV PHARM
LANNETT
LANNETT
PARKE DAVIS
PERRIGO
PUREPAC PHARM
VALEANT PHARM INTL
VITARINE
VITARINE
WATSON LABS
WEST WARD
WYETH AYERST
MARATHON PHARMS
MARATHON PHARMS
PROMIUS PHARMA
PROMIUS PHARMA
AAIPHARMA LLC
APOTEX
DAVA PHARMS INC
AUXILIUM PHARMS LLC
ALPHARMA US PHARMS
ALPHARMA US PHARMS
ALPHARMA US PHARMS
PURDUE GMP
PFIZER
PFIZER
PFIZER
PFIZER
PFIZER
PFIZER
CARDINAL HLTH 414
CARDINAL HLTH 414
CARDINAL HLTH 414
GE HEALTHCARE
MALLINCKRODT
MALLINCKRODT
CIS
CIS
MALLINCKRODT
MALLINCKRODT
MALLINCKRODT
JUBILANT DRAXIMAGE
JUBILANT DRAXIMAGE
ANABOLIC
ELKINS SINN
EVERYLIFE
HALSEY
PARKE DAVIS
PERRIGO
PUREPAC PHARM
VALEANT PHARM INTL
WATSON LABS
WYETH AYERST
ROCHE
MEDA PHARMS
FISONS
Strength
EQ 4.5MG BASE
EQ 6MG BASE
EQ 1.5MG BASE
EQ 3MG BASE
EQ 4.5MG BASE
EQ 6MG BASE
EQ 1.5MG BASE
EQ 3MG BASE
EQ 4.5MG BASE
EQ 6MG BASE
EQ 1.5MG BASE
EQ 3MG BASE
EQ 4.5MG BASE
EQ 6MG BASE
EQ 1.5MG BASE
EQ 3MG BASE
EQ 4.5MG BASE
EQ 6MG BASE
EQ 1.5MG BASE
EQ 3MG BASE
EQ 4.5MG BASE
EQ 6MG BASE
250MG
500MG
0.25MCG
0.5MCG
EQ 140MG BASE
EQ 280MG BASE
500MG;5MG
0.5‐1uCi
0.5‐1uCi
25MG
50MG
100MG
EQ 10MG BASE
EQ 20MG BASE
100MG
100MG
100MG
100MG
100MG
100MG
50MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG
50MG
100MG
EQ 200MG BASE
EQ 400MG BASE
5MG
5MG
5MG
8MG;60MG
10MG
15MG
30MG
250MG
EQ 10MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
EQ 150MG BASE
100uCi
200uCi
400uCi
100uCi
100uCi
200uCi
50uCi
100uCi
0.8‐100mCi
0.8‐100mCi
15‐100uCi
2‐200mCi
9‐100mCi
100MG
100MG
100MG
100MG
50MG
100MG
100MG
100MG
100MG
100MG
100MG
100MG
30MG
250MG
100MG
Page 00098
Appl_Type
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
A
A
A
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
A
A
A
N
N
N
N
A
N
N
N
N
N
N
N
N
N
N
A
A
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
N
N
A
91689
3 AB
91689
4 AB
91072
1 AB
91072
2 AB
91072
3 AB
91072
4 AB
77130
1 AB
77130
2 AB
77130
3 AB
77130
4 AB
203148
1 AB
203148
2 AB
203148
3 AB
203148
4 AB
77131
1 AB
77131
2 AB
77131
3 AB
77131
4 AB
77129
1 AB
77129
2 AB
77129
3 AB
77129
4 AB
61734
1
61734
2
18044
1 AB
18044
2 AB
60641
1
60641
2
40061
1
16089
2
16090
2
50625
1 AB2
50625
3 BX
50625
2 AB2
18936
7 AB2
18936
8 AB2
84422
1
84225
1
85895
1
84676
1
85869
1
85285
1
85909
1
85903
1
84762
1
84561
1
85867
1
85477
1
85898
1
86273
1
85792
1
84926
1
85798
1
86390
1
86101
1
86101
2
18917
1 AB
18917
3 AB
75145
1
75321
1 AB
75352
1 AB
19806
1
15539
2
15539
4
15539
6
60593
1
16798
3
16798
1
16798
2
16798
6
16798
5
16798
7
18671
1 AA
18671
2 AA
18671
3
17630
1
71909
1 AA
71910
1 AA
17316
1
17316
2
16515
2
16517
1
16517
2
21305
4
21305
6
84590
1
83368
1
83259
1
84677
1
83461
1
83461
2
84156
1
84560
1
83301
1
83264
1
85791
1
83239
1
17589
1
11792
3
87155
1
Approval_Date
12‐Jun‐12
12‐Jun‐12
16‐May‐13
16‐May‐13
16‐May‐13
16‐May‐13
31‐Oct‐07
31‐Oct‐07
31‐Oct‐07
31‐Oct‐07
22‐Aug‐14
22‐Aug‐14
22‐Aug‐14
22‐Aug‐14
22‐Oct‐07
22‐Oct‐07
22‐Oct‐07
22‐Oct‐07
8‐Jan‐08
8‐Jan‐08
8‐Jan‐08
8‐Jan‐08
3‐Jul‐95
2‐Mar‐90
23‐Nov‐92
2‐Mar‐90
6‐Jul‐00
6‐Jul‐00
3‐Oct‐83
3‐Oct‐83
28‐Dec‐84
28‐Dec‐84
15‐Sep‐03
4‐Dec‐98
30‐Nov‐98
25‐Mar‐94
27‐May‐82
27‐May‐82
27‐May‐82
28‐Feb‐89
28‐Feb‐89
18‐Nov‐04
19‐May‐05
25‐Feb‐85
RLD
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
Yes
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
Yes
No
No
No
Yes
No
No
No
Yes
No
No
No
No
No
No
Yes
Yes
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Type
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
RX
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
Applicant_Full_Name
APOTEX INC
APOTEX INC
APOTEX INC
APOTEX INC
MACLEODS PHARMACEUTICALS LTD
VALIDUS PHARMACEUTICALS LLC
VALIDUS PHARMACEUTICALS LLC
ELI LILLY AND CO
ELI LILLY AND CO
ANABOLIC INC
EVERYLIFE
HALSEY DRUG CO INC
LANNETT CO INC
LANNETT CO INC
L PERRIGO CO
MARATHON PHARMACEUTICALS LLC
MARATHON PHARMACEUTICALS LLC
PROMIUS PHARMA LLC
PROMIUS PHARMA LLC
AAIPHARMA LLC
APOTEX INC
AUXILIUM PHARMACEUTICALS LLC
PURDUE GMP CENTER LLC DBA THE CHAO CENTER INDUSTRIAL PHARMACY
CARDINAL HEALTH 414
CARDINAL HEALTH 414
CARDINAL HEALTH 414
GE HEALTHCARE
CIS BIOINDUSTRIES COMPAGNIE
CIS BIOINDUSTRIES COMPAGNIE
JUBILANT DRAXIMAGE INC
ANABOLIC INC
EVERYLIFE
HALSEY DRUG CO INC
L PERRIGO CO
MEDA PHARMACEUTICALS MEDA PHARMACEUTICALS INC
FISONS CORP
Page 00099
Ingredient
THEOPHYLLINE
THEOPHYLLINE
ZALEPLON
ZALEPLON
ACITRETIN
ACITRETIN
ACITRETIN
ACITRETIN
ISOTRETINOIN
ISOTRETINOIN
ISOTRETINOIN
ISOTRETINOIN
ITRACONAZOLE
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
SULFINPYRAZONE
SULFINPYRAZONE
SULFINPYRAZONE
SULFINPYRAZONE
SUNITINIB MALATE
SUNITINIB MALATE
SUNITINIB MALATE
SUNITINIB MALATE
CEFIXIME
TRIMIPRAMINE MALEATE
EFAVIRENZ
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
EFAVIRENZ
EFAVIRENZ
SUNITINIB MALATE
SUNITINIB MALATE
SUNITINIB MALATE
SUNITINIB MALATE
ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE
TRIENTINE HYDROCHLORIDE
CHLOROTRIANISENE
CHLOROTRIANISENE
CHLOROTRIANISENE
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
DABRAFENIB MESYLATE
DABRAFENIB MESYLATE
OSELTAMIVIR PHOSPHATE
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00100
Trade_Name
SOMOPHYLLIN‐T
SOMOPHYLLIN‐T
SONATA
SONATA
SORIATANE
SORIATANE
SORIATANE
SORIATANE
SOTRET
SOTRET
SOTRET
SOTRET
SPORANOX
SPRX‐3
STATOBEX
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
STRATTERA
STRATTERA
STRATTERA
STRATTERA
STRATTERA
STRATTERA
STRATTERA
STRATTERA
SULFINPYRAZONE
SULFINPYRAZONE
SULFINPYRAZONE
SULFINPYRAZONE
SUMYCIN
SUMYCIN
SUMYCIN
SUMYCIN
SUNITINIB MALATE
SUNITINIB MALATE
SUNITINIB MALATE
SUNITINIB MALATE
SUPRAX
SURMONTIL
SURMONTIL
SURMONTIL
SUSTIVA
Applicant
FISONS
FISONS
PFIZER
PFIZER
STIEFEL LABS INC
STIEFEL LABS INC
STIEFEL LABS INC
STIEFEL LABS INC
RANBAXY
RANBAXY
RANBAXY
RANBAXY
JANSSEN PHARMS
SOLVAY
TEVA
AUROBINDO PHARMA
AUROBINDO PHARMA
AUROBINDO PHARMA
AUROBINDO PHARMA
HETERO LABS LTD III
HETERO LABS LTD III
HETERO LABS LTD III
HETERO LABS LTD III
MATRIX LABS LTD
MATRIX LABS LTD
MYLAN
MYLAN
MYLAN
MYLAN
LILLY
LILLY
LILLY
LILLY
LILLY
LILLY
LILLY
LILLY
BARR
IVAX PHARMS
PAR PHARM
VANGARD
APOTHECON
APOTHECON
APOTHECON
APOTHECON
MYLAN PHARMS INC
MYLAN PHARMS INC
MYLAN PHARMS INC
MYLAN PHARMS INC
LUPIN LTD
ODYSSEY PHARMS
ODYSSEY PHARMS
ODYSSEY PHARMS
SUSTIVA
SUSTIVA
SUTENT
SUTENT
SUTENT
SUTENT
SYMADINE
SYMBYAX
SYMBYAX
SYMBYAX
SYMBYAX
SYMBYAX
SYMMETREL
SYNALGOS‐DC
SYNALGOS‐DC‐A
SYPRINE
TACE
TACE
TACE
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TACROLIMUS
TAFINLAR
TAFINLAR
TAMIFLU
TAMIFLU
TAMIFLU
CPPI CV
CPPI CV
CPPI CV
CPPI CV
SOLVAY
LILLY
LILLY
LILLY
LILLY
LILLY
ENDO PHARMS
CARACO
LEITNER PHARMS
ATON
SANOFI AVENTIS US
SANOFI AVENTIS US
SANOFI AVENTIS US
ACCORD HLTHCARE
ACCORD HLTHCARE
ACCORD HLTHCARE
DR REDDYS LABS LTD
DR REDDYS LABS LTD
DR REDDYS LABS LTD
MYLAN
MYLAN
MYLAN
PANACEA BIOTEC LTD
PANACEA BIOTEC LTD
PANACEA BIOTEC LTD
SANDOZ
SANDOZ
SANDOZ
STRIDES PHARMA
STRIDES PHARMA
STRIDES PHARMA
WATSON LABS
GLAXOSMITHKLINE
GLAXOSMITHKLINE
ROCHE
ROCHE
ROCHE
ANCHEN PHARMS
Strength
200MG
250MG
5MG
10MG
10MG
17.5MG
22.5MG
25MG
10MG
20MG
30MG
40MG
100MG
35MG
35MG
15MG
20MG
30MG
40MG
15MG
20MG
30MG
40MG
30MG
40MG
15MG
20MG
30MG
40MG
5MG
10MG
18MG
25MG
40MG
60MG
80MG
100MG
200MG
200MG
200MG
200MG
100MG
125MG
250MG
500MG
EQ 12.5MG BASE
EQ 25MG BASE
EQ 37.5MG BASE
EQ 50MG BASE
400MG
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
50MG
200MG
EQ 12.5MG BASE
EQ 25MG BASE
EQ 37.5MG BASE
EQ 50MG BASE
100MG
100MG
356.4MG;30MG;16MG
356.4MG;30MG;16MG
250MG
12MG
25MG
72MG
EQ 0.5MG BASE
EQ 1MG BASE
EQ 5MG BASE
EQ 0.5MG BASE
EQ 1MG BASE
EQ 5MG BASE
EQ 0.5MG BASE
EQ 1MG BASE
EQ 5MG BASE
EQ 0.5MG BASE
EQ 1MG BASE
EQ 5MG BASE
EQ 0.5MG BASE
EQ 1MG BASE
EQ 5MG BASE
EQ 0.5MG BASE
EQ 1MG BASE
EQ 5MG BASE
EQ 5MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 30MG BASE
EQ 45MG BASE
EQ 75MG BASE
0.4MG
0.4MG
Page 00101
Appl_Type
A
A
N
N
N
N
N
N
A
A
A
A
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
N
N
N
N
A
N
N
N
N
N
N
N
A
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
A
A
87155
2
87155
3
20859
1 AB
20859
2 AB
19821
1 AB
19821
3 AB
19821
4 AB
19821
2 AB
76041
1 AB
76041
2 AB
76503
1 AB
76041
3 AB
20083
1 AB
85897
1
85507
1
77672
3 AB
77672
4 AB
77672
1 AB
77672
2 AB
78957
1 AB
78957
2 AB
78957
3 AB
78957
4 AB
78775
1 AB
78775
2 AB
79069
1 AB
79069
2 AB
79069
3 AB
79069
4 AB
21411
1
21411
2
21411
3
21411
4
21411
5
21411
6
21411
7
21411
8
87666
1
87770
1
88934
1
88666
1
60429
2
60429
4
60429
1
60429
3
201275
1 AB
201275
2 AB
201275
3 AB
201275
4 AB
203195
1
16792
1 AB
16792
2 AB
16792
3 AB
20972
1
20972
20972
21938
21938
21938
21938
71000
21520
21520
21520
21520
21520
16020
11483
89166
19194
8102
11444
16235
91195
91195
91195
90509
90509
90509
90596
90596
90596
90802
90802
90802
65461
65461
65461
90687
90687
90687
90402
202806
202806
21087
21087
21087
202010
202433
2
3
1
2
4
3
1
1
2
4
3
5
1
4
1
1
4
1
1
1
2
3
1
2
3
1
2
3
1
2
3
1
2
3
1
2
3
1
1
2
3
2
1
1
1
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
Approval_Date
25‐Feb‐85
25‐Feb‐85
13‐Aug‐99
13‐Aug‐99
28‐Oct‐96
6‐Aug‐09
6‐Aug‐09
28‐Oct‐96
24‐Dec‐02
24‐Dec‐02
20‐Jun‐03
24‐Dec‐02
11‐Sep‐92
29‐Dec‐08
29‐Dec‐08
29‐Dec‐08
29‐Dec‐08
29‐Dec‐08
29‐Dec‐08
29‐Dec‐08
29‐Dec‐08
5‐Jan‐09
5‐Jan‐09
29‐Dec‐08
29‐Dec‐08
29‐Dec‐08
29‐Dec‐08
26‐Nov‐02
26‐Nov‐02
26‐Nov‐02
26‐Nov‐02
26‐Nov‐02
26‐Nov‐02
14‐Feb‐05
14‐Feb‐05
17‐Sep‐82
19‐Nov‐82
6‐Sep‐85
17‐Feb‐84
30‐Jan‐14
30‐Jan‐14
30‐Jan‐14
30‐Jan‐14
1‐Jun‐12
15‐Sep‐82
17‐Sep‐98
RLD
No
No
No
Yes
No
No
No
Yes
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
Yes
No
Type
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
Applicant_Full_Name
FISONS CORP
FISONS CORP
PFIZER INC
PFIZER INC
MATRIX LABORATORIES LTD
MATRIX LABORATORIES LTD
ELI LILLY AND CO
ELI LILLY AND CO
ELI LILLY AND CO
ELI LILLY AND CO
ELI LILLY AND CO
ELI LILLY AND CO
ELI LILLY AND CO
ELI LILLY AND CO
LUPIN LTD
ODYSSEY PHARMACEUTICALS INC
17‐Sep‐98
17‐Sep‐98
26‐Jan‐06
26‐Jan‐06
31‐Mar‐09
26‐Jan‐06
4‐Sep‐86
9‐Apr‐07
24‐Dec‐03
24‐Dec‐03
24‐Dec‐03
24‐Dec‐03
6‐Sep‐83
14‐May‐86
8‐Nov‐85
31‐Aug‐11
31‐Aug‐11
31‐Aug‐11
12‐May‐10
12‐May‐10
12‐May‐10
17‐Sep‐10
17‐Sep‐10
17‐Sep‐10
28‐Sep‐12
28‐Sep‐12
28‐Sep‐12
10‐Aug‐09
10‐Aug‐09
10‐Aug‐09
22‐Jul‐14
22‐Jul‐14
22‐Jul‐14
1‐Jul‐10
29‐May‐13
29‐May‐13
2‐Jul‐07
2‐Jul‐07
27‐Oct‐99
4‐Jan‐13
30‐Apr‐13
No
Yes
No
No
No
Yes
No
No
No
No
Yes
No
No
Yes
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
Yes
No
No
DISCN
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
DISCN
RX
DISCN
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
CP PHARMACEUTICALS INTERNATIONAL CV
ELI LILLY AND CO
ELI LILLY AND CO
ELI LILLY AND CO
ELI LILLY AND CO
ELI LILLY AND CO
CARACO PHARMACEUTICAL LABORATORIES LTD
LEITNER PHARMACEUTICALS LLC
ATON PHARMA INC
PANACEA BIOTEC LTD
PANACEA BIOTEC LTD
PANACEA BIOTEC LTD
SANDOZ INC
SANDOZ INC
SANDOZ INC
GLAXOSMITHKLINE
GLAXOSMITHKLINE
Page 00102
Ingredient
TROLEANDOMYCIN
BEXAROTENE
NILOTINIB HYDROCHLORIDE MONOHYDRATE
NILOTINIB HYDROCHLORIDE MONOHYDRATE
ETRETINATE
ETRETINATE
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
BENZONATATE
BENZONATATE
METHYLTESTOSTERONE
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00103
Trade_Name
TAO
TARGRETIN
TASIGNA
TASIGNA
TEGISON
TEGISON
TEMAZ
TEMAZ
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMAZEPAM
TEMODAR
TEMODAR
TEMODAR
TEMODAR
TEMODAR
TEMODAR
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TEMOZOLOMIDE
TENCON
TERRAMYCIN
TERRAMYCIN
TESSALON
TESSALON
TESTRED
TETRACHEL
TETRACHEL
Applicant
IMPAX LABS
MYLAN
SANDOZ
SUN PHARM INDS LTD
SYNTHON PHARMS
TEVA PHARMS
WOCKHARDT
PFIZER
VALEANT LUXEMBOURG
NOVARTIS
NOVARTIS
ROCHE
ROCHE
QUANTUM PHARMICS
QUANTUM PHARMICS
ACTAVIS ELIZABETH
ACTAVIS ELIZABETH
DURAMED PHARMS BARR
DURAMED PHARMS BARR
MUTUAL PHARM
MUTUAL PHARM
MUTUAL PHARM
MUTUAL PHARM
MYLAN
MYLAN
MYLAN
MYLAN
NOVEL LABS INC
NOVEL LABS INC
NOVEL LABS INC
NOVEL LABS INC
SANDOZ
SANDOZ
USL PHARMA
USL PHARMA
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
MERCK SHARP DOHME
MERCK SHARP DOHME
MERCK SHARP DOHME
MERCK SHARP DOHME
MERCK SHARP DOHME
MERCK SHARP DOHME
BARR
BARR
BARR
BARR
BARR
BARR
SUN PHARMA GLOBAL
SUN PHARMA GLOBAL
SUN PHARMA GLOBAL
SUN PHARMA GLOBAL
SUN PHARMA GLOBAL
SUN PHARMA GLOBAL
MALLINCKRODT
APOTEX
APOTEX
APOTEX
APOTEX
JUBILANT CADISTA
JUBILANT CADISTA
JUBILANT CADISTA
JUBILANT CADISTA
MYLAN
MYLAN
MYLAN
MYLAN
MYLAN TECHNOLOGIES
MYLAN TECHNOLOGIES
MYLAN TECHNOLOGIES
MYLAN TECHNOLOGIES
RANBAXY LABS LTD
RANBAXY LABS LTD
RANBAXY LABS LTD
RANBAXY LABS LTD
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
PFIZER
PFIZER
PFIZER
PFIZER
VALEANT PHARM INTL
ANGUS
ANGUS
ABBOTT
ABBOTT
Strength
0.4MG
0.4MG
0.4MG
0.4MG
0.4MG
0.4MG
0.4MG
0.4MG
EQ 250MG BASE
75MG
EQ 150MG BASE
EQ 200MG BASE
10MG
25MG
15MG
30MG
15MG
30MG
15MG
30MG
7.5MG
15MG
22.5MG
30MG
7.5MG
15MG
22.5MG
30MG
7.5MG
15MG
22.5MG
30MG
15MG
30MG
15MG
30MG
15MG
15MG
30MG
30MG
5MG
20MG
100MG
140MG
180MG
250MG
5MG
20MG
100MG
140MG
180MG
250MG
5MG
20MG
100MG
140MG
180MG
250MG
650MG;50MG
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 1MG BASE
EQ 1MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 5MG BASE
EQ 5MG BASE
EQ 10MG BASE
EQ 10MG BASE
EQ 125MG BASE
EQ 250MG BASE
100MG
200MG
10MG
250MG
500MG
250MG
500MG
Page 00104
Appl_Type
A
A
A
A
A
A
A
A
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
A
A
A
A
A
90377
1 AB
90408
1 AB
78015
1 AB
90931
1 AB
78801
1 AB
77630
1 AB
78938
1 AB
78225
1 AB
50336
2
21055
1
22068
2
22068
1
19369
1
19369
2
70564
1
70547
1
71638
1 AB
71620
1 AB
71708
1
71709
1
78581
1 AB
71174
1
71175
2 AB
71175
1
70920
2 AB
70920
4 AB
70920
3 AB
70920
1 AB
71457
2 AB
71456
1 AB
71457
3 AB
71457
1 AB
71427
1 AB
71428
1 AB
70489
1
70490
1
70383
1
71446
1
70384
1
71447
1
21029
1 AB
21029
2 AB
21029
3 AB
21029
5 AB
21029
6 AB
21029
4 AB
78879
1 AB
78879
2 AB
78879
3 AB
78879
5 AB
78879
6 AB
78879
4 AB
201742
1 AB
201742
2 AB
201742
3 AB
201742
4 AB
201742
5 AB
201742
6 AB
89405
1
75498
1 AB
75498
2 AB
75498
3 AB
75498
4 AB
75614
2 AB
75614
1 AB
75614
3 AB
75614
4 AB
75317
1 AB
75317
2 AB
75317
3 AB
75317
4 AB
75140
2 AB
75140
3 AB
75140
1 AB
75140
4 AB
75384
1
75384
2
75384
3
75384
4
76021
1
76021
2
76021
3
76021
4
74823
1 AB
75667
1
74823
2 AB
75667
2
74823
3 AB
75667
3
74823
4 AB
75667
4
50286
1
50286
2
11210
1 AA
11210
3 AA
83976
1
60343
1
60343
3
61802
1
61802
2
Approval_Date
2‐Mar‐10
27‐Apr‐10
27‐Apr‐10
15‐Jul‐10
27‐Apr‐10
27‐Apr‐10
27‐Apr‐10
27‐Apr‐10
29‐Dec‐99
17‐Jun‐10
29‐Oct‐07
30‐Sep‐86
30‐Sep‐86
15‐Oct‐85
15‐Oct‐85
7‐Aug‐87
7‐Aug‐87
29‐Sep‐88
29‐Sep‐88
8‐Sep‐09
10‐Jul‐86
14‐Sep‐09
10‐Jul‐86
21‐May‐10
7‐Jul‐86
12‐Jun‐09
10‐Jul‐86
22‐Jun‐12
21‐Apr‐87
22‐Jun‐12
21‐Apr‐87
12‐Jan‐88
12‐Jan‐88
7‐Jul‐86
7‐Jul‐86
23‐Mar‐87
21‐May‐93
23‐Mar‐87
21‐May‐93
11‐Aug‐99
11‐Aug‐99
11‐Aug‐99
19‐Oct‐06
19‐Oct‐06
11‐Aug‐99
1‐Mar‐10
1‐Mar‐10
1‐Mar‐10
1‐Mar‐10
1‐Mar‐10
1‐Mar‐10
12‐Feb‐14
12‐Feb‐14
12‐Feb‐14
12‐Feb‐14
12‐Feb‐14
12‐Feb‐14
15‐May‐90
12‐Apr‐01
12‐Apr‐01
12‐Apr‐01
12‐Apr‐01
30‐Jan‐01
30‐Jan‐01
30‐Jan‐01
30‐Jan‐01
20‐Dec‐04
20‐Dec‐04
20‐Dec‐04
20‐Dec‐04
11‐Feb‐00
11‐Feb‐00
11‐Feb‐00
11‐Feb‐00
1‐Dec‐00
1‐Dec‐00
1‐Dec‐00
1‐Dec‐00
22‐Aug‐02
22‐Aug‐02
22‐Aug‐02
22‐Aug‐02
30‐Mar‐98
28‐Jul‐00
30‐Mar‐98
28‐Jul‐00
30‐Mar‐98
28‐Jul‐00
30‐Mar‐98
28‐Jul‐00
25‐Jun‐99
RLD
No
No
No
No
No
No
No
No
No
Yes
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
Yes
Yes
Yes
No
No
No
No
Type
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
RX
DISCN
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
DISCN
RX
DISCN
RX
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
Applicant_Full_Name
SANDOZ INC
SYNTHON PHARMACEUTICALS INC
WOCKHARDT LTD
PFIZER PHARMACEUTICALS INC
VALEANT PHARMACEUTICALS LUXEMBOURG SARL
NOVEL LABORATORIES INC
SANDOZ INC
SANDOZ INC
USL PHARMA INC
USL PHARMA INC
APOTEX INC
APOTEX INC
APOTEX INC
APOTEX INC
MYLAN TECHNOLOGIES INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
PFIZER INC
PFIZER INC
ANGUS CHEMICAL CO
ANGUS CHEMICAL CO
Page 00105
Ingredient
TETRACYCLINE PHOSPHATE COMPLEX
THALIDOMIDE
THALIDOMIDE
THALIDOMIDE
THALIDOMIDE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
TRIMETHOBENZAMIDE HYDROCHLORIDE
DOFETILIDE
DOFETILIDE
DOFETILIDE
LEVOTHYROXINE SODIUM
INDOMETHACIN
INDOMETHACIN
TIZANIDINE HYDROCHLORIDE
IMIPRAMINE PAMOATE
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00106
Trade_Name
TETRACYN
TETRACYN
TETREX
TETREX
TETREX
TETREX
TETREX
TETREX
TETREX
THALOMID
THALOMID
THALOMID
THALOMID
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
THIOTHIXENE
TIGAN
TIKOSYN
TIKOSYN
TIKOSYN
TIROSINT
TIROSINT
TIROSINT
TIROSINT
TIROSINT
TIROSINT
TIROSINT
TIROSINT
TIROSINT
TIROSINT
TIVORBEX
TIVORBEX
TOFRANIL‐PM
Applicant
ELKINS SINN
FERRANTE
FERRANTE
HEATHER
HEATHER
HIKMA PHARMS LLC
HIKMA PHARMS LLC
IMPAX LABS
IMPAX LABS
IMPAX LABS
LABS ATRAL
LABS ATRAL
MAST MM
MUTUAL PHARM
MUTUAL PHARM
MYLAN
MYLAN
PUREPAC PHARM
PUREPAC PHARM
PVT FORM
PVT FORM
ROXANE
SANDOZ
SUPERPHARM
SUPERPHARM
VALEANT PHARM INTL
VALEANT PHARM INTL
WARNER CHILCOTT
WARNER CHILCOTT
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WYETH AYERST
WYETH AYERST
PFIPHARMECS
PFIPHARMECS
BRISTOL
BRISTOL
BRISTOL
BRISTOL
BRISTOL
BRISTOL
BRISTOL
CELGENE
CELGENE
CELGENE
CELGENE
KV PHARM
KV PHARM
SCHERER RP
SCHERER RP
SCHERER RP
AM THERAP
AM THERAP
AM THERAP
AM THERAP
AM THERAP
MYLAN
MYLAN
MYLAN
MYLAN
SANDOZ
SANDOZ
SANDOZ
SANDOZ
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
KING PHARMS
PFIZER
PFIZER
PFIZER
INST BIOCHIMIQUE
INSTITUT BIOCHIMIQUE
IROKO PHARMS LLC
IROKO PHARMS LLC
APOTEX INC
APOTEX INC
APOTEX INC
MYLAN PHARMS INC
MYLAN PHARMS INC
MYLAN PHARMS INC
MALLINCKRODT INC
Strength
250MG
125MG
250MG
250MG
500MG
250MG
500MG
100MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
500MG
500MG
250MG
250MG
500MG
250MG
500MG
250MG
500MG
250MG
250MG
250MG
500MG
500MG
500MG
250MG
500MG
250MG
500MG
EQ 100MG HCL
EQ 250MG HCL
EQ 250MG HCL
EQ 250MG HCL
EQ 500MG HCL
EQ 500MG HCL
EQ 500MG HCL
50MG
100MG
150MG
200MG
100MG
200MG
100MG
200MG
250MG
1MG
2MG
5MG
10MG
20MG
1MG
2MG
5MG
10MG
1MG
2MG
5MG
10MG
1MG
2MG
2MG
5MG
5MG
10MG
10MG
300MG
0.125MG
0.25MG
0.5MG
0.013MG
0.025MG
0.05MG
0.075MG
0.088MG
0.1MG
0.112MG
0.125MG
0.137MG
0.15MG
20MG
40MG
EQ 2MG BASE
EQ 4MG BASE
EQ 6MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 6MG BASE
EQ 75MG HCL
Page 00107
Appl_Type
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
A
A
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
A
A
A
N
60059
1
60173
1
60173
2
61148
1
61148
2
60768
1
60768
2
60469
2
60469
1 AB
60469
3 AB
60704
1 AB
60704
2 AB
62752
1
62752
2
62085
1
60736
1
60736
2
60783
1
60783
2
60290
1
60290
2
62686
1
62686
2
61214
2
61471
1
62540
1
62540
2
60471
1
60471
2
62300
1
62300
2
61837
1 AB
62103
1
62343
1
61837
2 AB
62103
2
62343
2
61685
1
61685
2
60082
3
60082
4
61653
1
61653
2
61889
2
50212
2
61653
3
61889
1
50212
3
20785
1
20785
2
20785
4
20785
3
85263
1
85263
2
84731
2
84731
1
84731
3
71884
1
71885
1
71886
1
71887
1
72200
1
71093
2 AB
71093
3 AB
71093
4 AB
71093
1 AB
71610
1 AB
71570
1 AB
71529
1 AB
71530
1 AB
70600
1
70601
1
71626
1
70602
1
71627
1
70603
1
71628
1
17531
6 AB
20931
1
20931
2
20931
3
22121
1
21924
2
21924
3
21924
4
21924
10
21924
5
21924
8
21924
6
21924
9
21924
7
204768
1
204768
2
78868
1 AB
78868
2 AB
78868
3 AB
91502
1 AB
91502
2 AB
91502
3 AB
17090
1 AB
Approval_Date
12‐Aug‐88
12‐Aug‐88
24‐Jul‐86
24‐Jul‐86
21‐Mar‐85
21‐Mar‐85
16‐Jul‐98
17‐Jan‐03
10‐Jan‐07
17‐Jan‐03
7‐Nov‐86
7‐Nov‐86
7‐Nov‐86
12‐Aug‐87
12‐Aug‐87
12‐Aug‐87
12‐Aug‐87
17‐Dec‐87
23‐Jun‐87
23‐Jun‐87
23‐Jun‐87
23‐Jun‐87
24‐Jun‐87
24‐Jun‐87
24‐Jun‐87
24‐Jun‐87
5‐Jun‐87
5‐Jun‐87
25‐Jun‐87
5‐Jun‐87
25‐Jun‐87
5‐Jun‐87
25‐Jun‐87
13‐Dec‐01
1‐Oct‐99
1‐Oct‐99
1‐Oct‐99
1‐Aug‐07
13‐Oct‐06
13‐Oct‐06
13‐Oct‐06
2‐Oct‐09
13‐Oct‐06
2‐Oct‐09
13‐Oct‐06
2‐Oct‐09
13‐Oct‐06
24‐Feb‐14
24‐Feb‐14
3‐Feb‐12
3‐Feb‐12
3‐Feb‐12
9‐Nov‐12
9‐Nov‐12
9‐Nov‐12
RLD
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
Yes
No
No
No
No
No
No
No
No
No
Yes
No
Yes
No
No
No
No
No
No
Yes
Type
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
Applicant_Full_Name
JOHN J FERRANTE
JOHN J FERRANTE
HEATHER DRUG CO INC
HEATHER DRUG CO INC
MM MAST AND CO
SANDOZ INC
SUPERPHARM CORP
SUPERPHARM CORP
WARNER CHILCOTT INC
WARNER CHILCOTT INC
PFIPHARMECS DIV PFIZER INC
PFIPHARMECS DIV PFIZER INC
CELGENE CORP
CELGENE CORP
CELGENE CORP
CELGENE CORP
RP SCHERER NORTH AMERICA
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
PFIZER PHARMACEUTICALS PRODUCTION CORP LTD
INSTITUTE BIOCHIMIQUE SA (IBSA)
INSTITUT BIOCHIMIQUE SA IBSA
APOTEX INC
APOTEX INC
APOTEX INC
MALLINCKRODT INC
Page 00108
Ingredient
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
IMIPRAMINE PAMOATE
TOLMETIN SODIUM
TOLMETIN SODIUM
TOLMETIN SODIUM
TOLMETIN SODIUM
TOLMETIN SODIUM
TOLMETIN SODIUM
TOLMETIN SODIUM
TOLMETIN SODIUM
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
OXPRENOLOL HYDROCHLORIDE
TRETINOIN
TRETINOIN
FENOFIBRATE
FENOFIBRATE
FENOFIBRATE
TRIMETHADIONE
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE
NAFCILLIN SODIUM
DOXYLAMINE SUCCINATE
URACIL MUSTARD
URSODIOL
URSODIOL
URSODIOL
URSODIOL
URSODIOL
AMOXICILLIN
AMOXICILLIN
ETHINAMATE
VALPROIC ACID
VALPROIC ACID
VALPROIC ACID
VALPROIC ACID
VALPROIC ACID
VALPROIC ACID
VANCOMYCIN HYDROCHLORIDE
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00109
Trade_Name
TOFRANIL‐PM
TOFRANIL‐PM
TOFRANIL‐PM
TOLECTIN DS
TOLMETIN SODIUM
TOLMETIN SODIUM
TOLMETIN SODIUM
TOLMETIN SODIUM
TOLMETIN SODIUM
TOLMETIN SODIUM
TOLMETIN SODIUM
TOPAMAX
TOPAMAX
TOPAMAX SPRINKLE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOPIRAMATE
TOTACILLIN
TOTACILLIN
TOTACILLIN
TOTACILLIN
TRANXENE
TRANXENE
TRANXENE
TRASICOR
TRASICOR
TRASICOR
TRASICOR
TRETINOIN
TRETINOIN
TRIAD
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
TRIAPRIN
TRICOR (MICRONIZED)
TRICOR (MICRONIZED)
TRICOR (MICRONIZED)
TRIDIONE
TRIMOX
TRIMOX
TRIMOX
TRIMOX
TRIMOX
TRIMOX
TRIMOX
TRIMOX
TYLENOL W/ CODEINE NO. 3
TYLENOL W/ CODEINE NO. 4
TYLOX
TYLOX
TYLOX‐325
ULTRACEF
UNIPEN
UNISOM
URACIL MUSTARD
URSODIOL
URSODIOL
URSODIOL
URSODIOL
URSODIOL
UTIMOX
UTIMOX
VALMID
VALPROIC ACID
VALPROIC ACID
VALPROIC ACID
VALPROIC ACID
VALPROIC ACID
VALPROIC ACID
VANCOCIN HYDROCHLORIDE
Applicant
MALLINCKRODT INC
MALLINCKRODT INC
MALLINCKRODT INC
ORTHO MCNEIL JANSSEN
ACTAVIS ELIZABETH
MUTUAL PHARM
MYLAN
SANDOZ
TEVA
TEVA
JANSSEN PHARMS
JANSSEN PHARMS
JANSSEN PHARMS
BARR
BARR
MYLAN
MYLAN
SANDOZ
SANDOZ
TEVA
TEVA
WATSON LABS
WATSON LABS
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
RECORDATI RARE
RECORDATI RARE
RECORDATI RARE
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS
ANCHEN PHARMS
BARR LABS INC
MALLINCKRODT
BARR
DURAMED PHARMS BARR
MYLAN
NOVARTIS
SANDOZ
SANDOZ
VITARINE
DUNHALL
ABBVIE
ABBVIE
ABBVIE
ABBVIE
GAVIS PHARMS
MUTUAL PHARMA
MIKAH PHARMA
MIKAH PHARMA
MIKAH PHARMA
USL PHARMA
USL PHARMA
USL PHARMA
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
ORTHO MCNEIL PHARM
ORTHO MCNEIL PHARM
JANSSEN PHARMS
ORTHO MCNEIL PHARM
ORTHO MCNEIL PHARM
BRISTOL
WYETH AYERST
PFIZER
SHIRE
COREPHARMA
EPIC PHARMA
LANNETT
MYLAN
TEVA PHARMS
PARKE DAVIS
PARKE DAVIS
DISTA
BANNER PHARMACAPS
CATALENT
PAR PHARM
SCHERER RP
SUN PHARM INDS LTD
USL PHARMA
ANI PHARMS INC
ANI PHARMS INC
AKORN
AKORN
FRESENIUS KABI USA
FRESENIUS KABI USA
STRIDES PHARMA
Strength
EQ 100MG HCL
EQ 125MG HCL
EQ 150MG HCL
EQ 400MG BASE
EQ 400MG BASE
EQ 400MG BASE
EQ 400MG BASE
EQ 400MG BASE
EQ 400MG BASE
EQ 400MG BASE
EQ 400MG BASE
15MG
25MG
50MG
15MG
25MG
15MG
25MG
15MG
25MG
15MG
25MG
15MG
25MG
15MG
25MG
EQ 250MG BASE
EQ 250MG BASE
EQ 500MG BASE
EQ 500MG BASE
3.75MG
7.5MG
15MG
20MG
40MG
80MG
160MG
10MG
10MG
325MG;50MG;40MG
25MG;37.5MG
25MG;37.5MG
25MG;50MG
25MG;37.5MG
25MG;37.5MG
25MG;37.5MG
25MG;37.5MG
25MG;50MG
25MG;50MG
325MG;50MG
67MG
134MG
200MG
300MG
300MG
300MG
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
EQ 25MG BASE
EQ 50MG BASE
EQ 100MG BASE
250MG
250MG
250MG
250MG
500MG
500MG
500MG
500MG
300MG;30MG
300MG;60MG
500MG;5MG
500MG;4.5MG;0.38MG
325MG;5MG
EQ 500MG BASE
EQ 250MG BASE
25MG
1MG
300MG
300MG
300MG
300MG
300MG
250MG
500MG
500MG
250MG
250MG
250MG
250MG
250MG
250MG
EQ 125MG BASE
EQ 250MG BASE
EQ 125MG BASE
EQ 250MG BASE
EQ 125MG BASE
EQ 250MG BASE
EQ 125MG BASE
Page 00110
Appl_Type
N
N
N
N
A
A
A
A
A
A
A
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
A
A
A
A
A
A
A
N
A
A
A
A
A
A
N
N
A
A
A
A
A
17090
4 AB
17090
3 AB
17090
2 AB
18084
1
73308
1
73392
1
73311
1
73393
1 AB
73462
1
73290
1 AB
73519
1
20844
1 AB
20844
2 AB
20844
3
76448
1
76448
2
78418
1 AB
78418
2 AB
79206
1
79206
2
76575
1 AB
76575
2 AB
77868
1 AB
77868
2 AB
78877
1 AB
78877
2 AB
60060
1
62212
1
60060
2
62212
2
17105
1
17105
2
17105
3
18166
1
18166
2
18166
3
18166
4
201687
1 AB
77684
1 AB
89023
1
74970
1
75052
1 AB
74259
1 AB
201407
1 AB
74701
1 AB
74857
1
74821
1 AB
73191
1 AB
71737
1
89268
1
19304
2
19304
3
19304
4
5856
5
76546
1 AB
76570
1 AB
77361
1 AB
77361
2 AB
77361
3 AB
71283
1
71284
1
71285
1
61885
1
62098
1
62152
1
63099
1
61885
2
62098
2
62152
2
63099
2
87422
1
87421
1
88790
1
85375
1
88246
1
62378
1
50111
1
19440
1
12892
1
77895
1 AB
75517
1 AB
79082
1 AB
90530
1 AB
75592
1 AB
62107
1
62107
2
9750
1
73484
1 AB
73229
1 AB
70431
1
70195
1
91037
1 AB
70631
1
50606
1 AB
50606
2 AB
65478
1 AB
65478
2 AB
65453
1 AB
65453
2 AB
65490
1 AB
Approval_Date
24‐Jan‐92
24‐Jan‐92
27‐Nov‐91
27‐May‐93
30‐Apr‐92
27‐Nov‐91
29‐May‐92
26‐Oct‐98
26‐Oct‐98
26‐Oct‐98
15‐Apr‐09
15‐Apr‐09
14‐Oct‐09
14‐Oct‐09
14‐Oct‐09
14‐Oct‐09
17‐Apr‐09
17‐Apr‐09
15‐Apr‐09
15‐Apr‐09
14‐Oct‐09
14‐Oct‐09
28‐Dec‐83
28‐Dec‐83
28‐Dec‐83
28‐Dec‐83
24‐Oct‐12
22‐Jun‐07
19‐Jun‐85
6‐Jan‐98
18‐Jun‐99
30‐Mar‐95
9‐Dec‐11
7‐Jun‐96
9‐Sep‐97
5‐Jun‐97
31‐Jul‐91
12‐Feb‐88
2‐Jul‐87
9‐Feb‐98
30‐Jun‐99
30‐Jun‐99
20‐Aug‐03
28‐Aug‐03
2‐Aug‐06
2‐Aug‐06
2‐Aug‐06
8‐Dec‐87
8‐Dec‐87
8‐Dec‐87
20‐Mar‐92
20‐Mar‐92
12‐Dec‐84
8‐Nov‐84
16‐Mar‐82
5‐Feb‐86
27‐Jul‐06
14‐Mar‐00
15‐Dec‐08
17‐Feb‐10
25‐May‐00
29‐Jun‐93
29‐Oct‐91
28‐Feb‐86
2‐Jul‐87
22‐Feb‐13
11‐Jun‐87
15‐Apr‐86
15‐Apr‐86
9‐Apr‐12
9‐Apr‐12
18‐Jun‐12
18‐Jun‐12
9‐Apr‐12
RLD
No
No
No
No
No
No
No
No
No
Yes
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
Type
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
DISCN
RX
RX
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
RX
RX
RX
RX
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
Applicant_Full_Name
MALLINCKRODT INC
MALLINCKRODT INC
MALLINCKRODT INC
ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
SANDOZ INC
SANDOZ INC
DUNHALL PHARMACEUTICALS INC
ABBVIE INC
ABBVIE INC
ABBVIE INC
ABBVIE INC
GAVIS PHARMACEUTICALS LLC
MUTUAL PHARMACAL CO
MIKAH PHARMA LLC
MIKAH PHARMA LLC
MIKAH PHARMA LLC
USL PHARMA INC
USL PHARMA INC
USL PHARMA INC
COREPHARMA LLC
EPIC PHARMA LLC
DISTA PRODUCTS CO DIV ELI LILLY AND CO
USL PHARMA INC
AKORN INC
AKORN INC
FRESENIUS KABI USA LLC
Page 00111
Ingredient
OXAMNIQUINE
ICOSAPENT ETHYL
CEPHRADINE
CEPHRADINE
CEPHRADINE
CEPHRADINE
ETOPOSIDE
ETOPOSIDE
HETACILLIN POTASSIUM
HETACILLIN POTASSIUM
TRETINOIN
VITAMIN A PALMITATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
BOCEPREVIR
METHYLTESTOSTERONE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
HYDROXYZINE PAMOATE
VITAMIN A PALMITATE
VITAMIN A
VITAMIN A PALMITATE
VITAMIN A PALMITATE
VITAMIN A PALMITATE
VITAMIN A
VITAMIN A PALMITATE
VITAMIN A PALMITATE
VITAMIN A PALMITATE
VITAMIN A
VITAMIN A
VITAMIN A PALMITATE
VITAMIN A PALMITATE
VITAMIN A PALMITATE
VITAMIN A PALMITATE
VITAMIN A PALMITATE
VITAMIN A PALMITATE
VITAMIN A PALMITATE
VITAMIN A
VITAMIN A PALMITATE
VITAMIN A PALMITATE
VITAMIN A PALMITATE
VITAMIN A PALMITATE
VITAMIN A PALMITATE
VITAMIN A PALMITATE
ERGOCALCIFEROL
ERGOCALCIFEROL
ERGOCALCIFEROL
ERGOCALCIFEROL
ERGOCALCIFEROL
ERGOCALCIFEROL
ERGOCALCIFEROL
LISDEXAMFETAMINE DIMESYLATE
NIACIN
COLESEVELAM HYDROCHLORIDE
AMOXICILLIN
AMOXICILLIN
CRIZOTINIB
CRIZOTINIB
ORLISTAT
ENZALUTAMIDE
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ETHOSUXIMIDE
MIGLUSTAT
OXAZEPAM
OXAZEPAM
OXAZEPAM
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00112
Trade_Name
VANSIL
VASCEPA
VELOSEF
VELOSEF
VELOSEF '250'
VELOSEF '500'
VEPESID
VEPESID
VERSAPEN‐K
VERSAPEN‐K
VESANOID
VI‐DOM‐A
VIBRAMYCIN
VIBRAMYCIN
VICTRELIS
VIRILON
VISTARIL
VISTARIL
VISTARIL
VITAMIN A
VITAMIN A
VITAMIN A
VITAMIN A
VITAMIN A
VITAMIN A
VITAMIN A
VITAMIN A
VITAMIN A
VITAMIN A
VITAMIN A
VITAMIN A
VITAMIN A
VITAMIN A
VITAMIN A
VITAMIN A
VITAMIN A
VITAMIN A
VITAMIN A
VITAMIN A
VITAMIN A PALMITATE
VITAMIN A PALMITATE
VITAMIN A PALMITATE
VITAMIN A PALMITATE
VITAMIN A SOLUBILIZED
VITAMIN D
VITAMIN D
VITAMIN D
VITAMIN D
VITAMIN D
VITAMIN D
VITAMIN D
VYVANSE
VYVANSE
VYVANSE
VYVANSE
VYVANSE
VYVANSE
WAMPOCAP
WELCHOL
WYMOX
WYMOX
X‐TROZINE
XALKORI
XALKORI
XENICAL
XTANDI
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZALEPLON
ZANAFLEX
ZANAFLEX
ZANAFLEX
ZANTAC 150
ZANTAC 300
ZARONTIN
ZAVESCA
ZAXOPAM
ZAXOPAM
ZAXOPAM
ZEGERID
Applicant
STRIDES PHARMA
WATSON LABS
WATSON LABS
PFIZER
AMARIN PHARMS
APOTHECON
APOTHECON
ERSANA
ERSANA
DAVA PHARMS INC
DAVA PHARMS INC
BRISTOL
BRISTOL
ROCHE
BAYER PHARMS
PFIZER
PFIZER
MERCK SHARP DOHME
STAR PHARMS FL
PFIZER
PFIZER
PFIZER
BANNER PHARMACAPS
BANNER PHARMACAPS
CHASE CHEM
CHASE CHEM
CHASE CHEM
ELKINS SINN
EVERYLIFE
EVERYLIFE
EVERYLIFE
IMPAX LABS
IMPAX LABS
IMPAX LABS
MK LABS
MK LABS
WEST WARD
WEST WARD
WHARTON LABS
ARCUM
ARCUM
BANNER PHARMACAPS
BANNER PHARMACAPS
TEVA
BANNER PHARMACAPS
CHASE CHEM
EVERYLIFE
IMPAX LABS
LANNETT
VITARINE
WEST WARD
SHIRE DEVELOPMENT
SHIRE DEVELOPMENT
SHIRE DEVELOPMENT
SHIRE DEVELOPMENT
SHIRE DEVELOPMENT
SHIRE DEVELOPMENT
MEDPOINTE PHARM HLC
DAIICHI SANKYO
WYETH AYERST
WYETH AYERST
SHIRE RICHWOOD
PF PRISM CV
PF PRISM CV
HOFFMANN LA ROCHE
ASTELLAS
AUROBINDO PHARMA
AUROBINDO PHARMA
CIPLA LTD
CIPLA LTD
HIKMA PHARMS LLC
HIKMA PHARMS LLC
MYLAN
MYLAN
ORCHID HLTHCARE
ORCHID HLTHCARE
ROXANE
ROXANE
SANDOZ
SANDOZ
TEVA PHARMS
TEVA PHARMS
UNICHEM
UNICHEM
UPSHER SMITH
UPSHER SMITH
ACORDA
ACORDA
ACORDA
GLAXOSMITHKLINE
GLAXOSMITHKLINE
PARKE DAVIS
ACTELION PHARMS LTD
QUANTUM PHARMICS
QUANTUM PHARMICS
QUANTUM PHARMICS
SANTARUS INC
Strength
EQ 250MG BASE
EQ 125MG BASE
EQ 250MG BASE
250MG
1GM
250MG
500MG
250MG
500MG
50MG
100MG
EQ 225MG AMPICIL
EQ 450MG AMPICIL
10MG
EQ 50MG BASE
EQ 100MG BASE
200MG
10MG
EQ 25MG HCL
EQ 50MG HCL
EQ 100MG HCL
50,000USP UNITS
50,000 IU
50,000 IU
50,000USP UNITS
50,000USP UNITS
50,000 IU
50,000 IU
50,000 IU
50,000 IU
50,000 IU
50,000 IU
50,000 IU
20MG
30MG
40MG
50MG
60MG
70MG
500MG
375MG
250MG
500MG
35MG
200MG
250MG
120MG
40MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
5MG
10MG
EQ 2MG BASE
EQ 4MG BASE
EQ 6MG BASE
EQ 150MG BASE
EQ 300MG BASE
250MG
100MG
10MG
15MG
30MG
20MG;1.1GM
Page 00113
Appl_Type
A
A
A
N
N
A
A
N
N
N
N
A
A
N
A
N
N
N
A
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
N
A
A
A
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
A
A
A
N
65490
2 AB
65510
1 AB
65510
2 AB
18069
1
202057
1
61764
1
61764
2
50548
1
50548
2
19557
1
19557
2
61396
1
61396
2
20438
1
80972
1
50007
1 AB
50007
2 AB
202258
1
87750
1
11459
2 AB
11459
4 AB
11459
6
80702
1
83973
1
80860
1
80746
1
83207
1
83351
1
85479
1
80943
1
83114
1
83134
1
80952
1
80953
1
80955
1
83035
1
83190
1
83457
2
83457
1
80967
1
80985
1
83665
1
83311
1
83321
1
83948
1
83981
1
80921
1
80704
1 AA
80747
1
80956
1
80951
1
80825
1
84053
1
83102
1
21977
4
21977
1
21977
5
21977
2
21977
6
21977
3
11073
3
21141
1
62120
1
62120
2
87394
1
202570
1
202570
2
20766
1
203415
1
78829
1 AB
78829
2 AB
77505
1 AB
77505
2 AB
78147
1 AB
78147
2 AB
77238
1 AB
77238
2 AB
90374
1 AB
90374
2 AB
77237
1 AB
77237
2 AB
78095
1
78095
2
77239
1 AB
77239
2 AB
78989
1 AB
78989
2 AB
78706
1 AB
78706
2 AB
21447
1 AB
21447
2 AB
21447
3 AB
20095
1
20095
2
12380
1 AB
21348
1
70650
1
70640
1
70641
1
21849
1 AB
Approval_Date
9‐Apr‐12
9‐Apr‐12
9‐Apr‐12
26‐Jul‐12
30‐Dec‐86
30‐Dec‐86
22‐Nov‐95
13‐May‐11
24‐Nov‐82
10‐Dec‐07
23‐Feb‐07
10‐Dec‐07
23‐Feb‐07
10‐Dec‐07
23‐Feb‐07
26‐May‐00
22‐Sep‐82
26‐Aug‐11
26‐Aug‐11
23‐Apr‐99
31‐Aug‐12
6‐Jun‐08
6‐Jun‐08
20‐Jun‐08
20‐Jun‐08
25‐Nov‐08
25‐Nov‐08
6‐Jun‐08
6‐Jun‐08
17‐Sep‐09
17‐Sep‐09
6‐Jun‐08
6‐Jun‐08
6‐Jun‐08
6‐Jun‐08
6‐Jun‐08
6‐Jun‐08
6‐Jun‐08
6‐Jun‐08
6‐Jun‐08
6‐Jun‐08
29‐Aug‐02
29‐Aug‐02
29‐Aug‐02
8‐Mar‐94
8‐Mar‐94
31‐Jul‐03
1‐Mar‐88
1‐Mar‐88
1‐Mar‐88
27‐Feb‐06
RLD
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
Yes
Yes
No
No
No
No
Type
RX
RX
RX
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
RX
Applicant_Full_Name
AMARIN PHARMACEUTICALS IRELAND LTD
ERSANA INC SUB ER SQUIBB AND SONS
ERSANA INC SUB ER SQUIBB AND SONS
STAR PHARMACEUTICALS INC
CHASE CHEMICAL CO LP
EVERYLIFE
EVERYLIFE
EVERYLIFE
MK LABORATORIES INC
MK LABORATORIES INC
WHARTON LABORATORIES INC DIV US ETHICALS
ARCUM PHARMACEUTICAL CORP
ARCUM PHARMACEUTICAL CORP
EVERYLIFE
LANNETT CO INC
DAIICHI SANKYO INC
SHIRE RICHWOOD INC
PF PRISM CV
PF PRISM CV
CIPLA LTD
CIPLA LTD
ORCHID HEALTHCARE
ORCHID HEALTHCARE
SANDOZ INC
SANDOZ INC
ACORDA THERAPEUTICS INC
GLAXOSMITHKLINE
GLAXOSMITHKLINE
ACTELION PHARMACEUTICALS LTD
SANTARUS INC
Page 00114
Ingredient
PARICALCITOL
PARICALCITOL
PARICALCITOL
ISOTRETINOIN
ISOTRETINOIN
ISOTRETINOIN
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
STAVUDINE
ZIDOVUDINE
ZIDOVUDINE
DICLOFENAC POTASSIUM
DF;Route
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
AZITHROMYCIN
VORINOSTAT
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
DICLOFENAC
DICLOFENAC
ACYCLOVIR
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
CAPSULE;ORAL
Page 00115
Trade_Name
ZEGERID
ZEGERID OTC
ZEMPLAR
ZEMPLAR
ZEMPLAR
ZENATANE
ZENATANE
ZENATANE
ZERIT
ZERIT
ZERIT
ZERIT
ZERIT
ZIDOVUDINE
ZIDOVUDINE
ZIPSOR
Applicant
SANTARUS INC
MSD CONSUMER
ABBVIE
ABBVIE
ABBVIE
DR REDDYS LABS LTD
DR REDDYS LABS LTD
DR REDDYS LABS LTD
CIPLA LTD
APOTEX CORP
APOTEX CORP
APOTEX CORP
APOTEX CORP
DR REDDYS LABS INC
DR REDDYS LABS INC
DR REDDYS LABS INC
DR REDDYS LABS INC
LUPIN PHARMS
LUPIN PHARMS
LUPIN PHARMS
LUPIN PHARMS
MYLAN PHARMS INC
MYLAN PHARMS INC
MYLAN PHARMS INC
MYLAN PHARMS INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
WOCKHARDT LTD
WOCKHARDT LTD
WOCKHARDT LTD
WOCKHARDT LTD
DEPOMED INC
ZITHROMAX
ZOLINZA
ZONEGRAN
ZONEGRAN
ZONEGRAN
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZONISAMIDE
ZORVOLEX
ZORVOLEX
ZOVIRAX
PFIZER
MERCK
EISAI INC
EISAI INC
EISAI INC
ANI PHARMS INC
ANI PHARMS INC
ANI PHARMS INC
ANI PHARMS INC
ANI PHARMS INC
ANI PHARMS INC
APOTEX INC
APOTEX INC
APOTEX INC
BANNER PHARMACAPS
BANNER PHARMACAPS
BANNER PHARMACAPS
COREPHARMA
COREPHARMA
COREPHARMA
DR REDDYS LABS LTD
DR REDDYS LABS LTD
DR REDDYS LABS LTD
GLENMARK GENERICS
GLENMARK GENERICS
GLENMARK GENERICS
INVAGEN PHARMS
INVAGEN PHARMS
INVAGEN PHARMS
MUTUAL PHARM
MUTUAL PHARM
MUTUAL PHARM
MYLAN
MYLAN
MYLAN
MYLAN PHARMS INC
MYLAN PHARMS INC
MYLAN PHARMS INC
ROXANE
ROXANE
ROXANE
SANDOZ
SANDOZ
SANDOZ
SUN PHARM INDS (IN)
SUN PHARM INDS (IN)
SUN PHARM INDS (IN)
WATSON LABS
WATSON LABS
WATSON LABS
WOCKHARDT
WOCKHARDT
WOCKHARDT
ZYDUS PHARMS USA
ZYDUS PHARMS USA
ZYDUS PHARMS USA
IROKO PHARMS LLC
IROKO PHARMS LLC
DELCOR ASSET
Strength
40MG;1.1GM
20MG;1.1GM
1MCG
2MCG
4MCG
10MG
20MG
40MG
5MG
15MG
20MG
30MG
40MG
100MG
100MG
EQ 20MG BASE
EQ 40MG BASE
EQ 60MG BASE
EQ 80MG BASE
EQ 20MG BASE
EQ 40MG BASE
EQ 60MG BASE
EQ 80MG BASE
EQ 20MG BASE
EQ 40MG BASE
EQ 60MG BASE
EQ 80MG BASE
EQ 20MG BASE
EQ 40MG BASE
EQ 60MG BASE
EQ 80MG BASE
EQ 20MG BASE
EQ 40MG BASE
EQ 60MG BASE
EQ 80MG BASE
EQ 20MG BASE
EQ 40MG BASE
EQ 60MG BASE
EQ 80MG BASE
25MG
100MG
25MG
50MG
100MG
25MG
25MG
50MG
50MG
100MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
25MG
50MG
100MG
18MG
35MG
200MG
Page 00116
Appl_Type
N
N
N
N
N
A
A
A
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
21849
2 AB
22281
1
21606
1 AB
21606
2 AB
21606
3 AB
202099
1 AB
202099
2 AB
202099
3 AB
20412
1
20412
2 AB
20412
3 AB
20412
4 AB
20412
5 AB
78128
1 AB
78349
1 AB
77561
1 AB
77561
2 AB
77561
3 AB
77561
4 AB
77565
1 AB
77565
2 AB
77565
3 AB
77565
4 AB
77560
1 AB
77560
2 AB
77560
3 AB
77560
4 AB
202395
1 AB
202395
2 AB
202395
3 AB
202395
4 AB
77562
1 AB
77562
2 AB
77562
3 AB
77562
4 AB
90348
1 AB
90348
2 AB
90348
3 AB
90348
4 AB
22202
1
50670
21991
20789
20789
20789
77639
77641
77639
77641
77639
77641
77642
77642
77642
77813
77813
77813
77876
77876
77876
77645
77645
77645
77651
77651
77651
77869
77869
77869
77635
77635
77635
77637
77637
77637
77647
77647
77647
77648
77648
77648
77644
77644
77644
77634
77634
77634
77650
77650
77650
77636
77636
77636
77625
77625
77625
204592
204592
18828
1
1
3
2
1
1
3
2
2
3
1
1
2
3
1
2
3
1
2
3
2
3
1
1
2
3
1
2
3
1
2
3
1
2
3
1
2
3
1
2
3
1
2
3
1
2
3
1
2
3
3
2
1
1
2
3
1
2
1
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
Approval_Date
27‐Feb‐06
1‐Dec‐09
26‐May‐05
26‐May‐05
26‐May‐05
25‐Mar‐13
25‐Mar‐13
25‐Mar‐13
24‐Jun‐94
24‐Jun‐94
24‐Jun‐94
24‐Jun‐94
24‐Jun‐94
27‐Mar‐06
23‐May‐07
2‐Mar‐12
2‐Mar‐12
2‐Mar‐12
2‐Mar‐12
2‐Mar‐12
2‐Mar‐12
2‐Mar‐12
2‐Mar‐12
2‐Mar‐12
2‐Mar‐12
2‐Mar‐12
2‐Mar‐12
10‐Oct‐13
10‐Oct‐13
10‐Oct‐13
10‐Oct‐13
1‐Jun‐12
1‐Jun‐12
1‐Jun‐12
1‐Jun‐12
5‐Sep‐12
5‐Sep‐12
5‐Sep‐12
5‐Sep‐12
16‐Jun‐09
RLD
Yes
Yes
No
No
Yes
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Type
RX
OTC
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
Applicant_Full_Name
SANTARUS INC
MSD CONSUMER CARE INC
ABBVIE INC
ABBVIE INC
ABBVIE INC
CIPLA LTD
APOTEX CORP
APOTEX CORP
APOTEX CORP
APOTEX CORP
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
WOCKHARDT LTD
WOCKHARDT LTD
WOCKHARDT LTD
WOCKHARDT LTD
DEPOMED INC
1‐Nov‐91
6‐Oct‐06
22‐Aug‐03
22‐Aug‐03
27‐Mar‐00
22‐Dec‐05
22‐Dec‐05
22‐Dec‐05
22‐Dec‐05
22‐Dec‐05
22‐Dec‐05
22‐Dec‐05
22‐Dec‐05
22‐Dec‐05
16‐Aug‐06
16‐Aug‐06
16‐Aug‐06
21‐Feb‐07
21‐Feb‐07
21‐Feb‐07
29‐Sep‐06
29‐Sep‐06
22‐Dec‐05
30‐Jan‐06
30‐Jan‐06
30‐Jan‐06
31‐May‐06
31‐May‐06
31‐May‐06
22‐Dec‐05
22‐Dec‐05
22‐Dec‐05
22‐Dec‐05
22‐Dec‐05
22‐Dec‐05
22‐Dec‐05
22‐Dec‐05
22‐Dec‐05
22‐Dec‐05
22‐Dec‐05
22‐Dec‐05
22‐Dec‐05
22‐Dec‐05
22‐Dec‐05
17‐Mar‐06
17‐Mar‐06
17‐Mar‐06
20‐Apr‐06
20‐Apr‐06
20‐Apr‐06
27‐Jul‐06
27‐Jul‐06
22‐Dec‐05
16‐Oct‐06
16‐Oct‐06
16‐Oct‐06
18‐Oct‐13
18‐Oct‐13
25‐Jan‐85
No
Yes
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
PFIZER CHEMICALS DIV PFIZER INC
MERCK AND CO INC
EISAI INC
EISAI INC
EISAI INC
COREPHARMA LLC
COREPHARMA LLC
COREPHARMA LLC
SANDOZ INC
SANDOZ INC
SANDOZ INC
WOCKHARDT LTD
WOCKHARDT LTD
WOCKHARDT LTD
DELCOR ASSET CORP
Page 00117
Ingredient
CERITINIB
ALPRAZOLAM
PROCHLORPERAZINE EDISYLATE
CROMOLYN SODIUM
CROMOLYN SODIUM
CROMOLYN SODIUM
DEXAMETHASONE
DIAZEPAM
DIAZEPAM
AMITRIPTYLINE HYDROCHLORIDE
FLUPHENAZINE HYDROCHLORIDE
CROMOLYN SODIUM
HALOPERIDOL LACTATE
HALOPERIDOL LACTATE
HALOPERIDOL LACTATE
HALOPERIDOL LACTATE
HALOPERIDOL LACTATE
HALOPERIDOL LACTATE
HALOPERIDOL LACTATE
HALOPERIDOL LACTATE
HALOPERIDOL LACTATE
IMIPRAMINE HYDROCHLORIDE
LORAZEPAM
LORAZEPAM
LORAZEPAM
LORAZEPAM
LORAZEPAM
LORAZEPAM
LOXAPINE HYDROCHLORIDE
THIORIDAZINE HYDROCHLORIDE
METHADONE HYDROCHLORIDE
METOCLOPRAMIDE HYDROCHLORIDE
THIOTHIXENE HYDROCHLORIDE
DF;Route
CAPSULE;ORAL
CLOTH;TOPICAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
LEVOMETHADYL ACETATE HYDROCHLORIDE
PERPHENAZINE
CARPHENAZINE MALEATE
MESORIDAZINE BESYLATE
SERTRALINE HYDROCHLORIDE
PROMAZINE HYDROCHLORIDE
PROMAZINE HYDROCHLORIDE
TRIFLUOPERAZINE HYDROCHLORIDE
CHLORPROTHIXENE
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
PERPHENAZINE
BETAMETHASONE DIPROPIONATE
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CONCENTRATE;ORAL
CREAM, AUGMENTED;TOPICAL
Page 00118
Trade_Name
ZYKADIA
ALPRAZOLAM
CHLORPROMAZINE HYDROCHLORIDE INTENSOL
CHLORPROMAZINE HYDROCHLORIDE INTENSOL
COMPAZINE
CROMOLYN SODIUM
CROMOLYN SODIUM
CROMOLYN SODIUM
DEXAMETHASONE INTENSOL
DIAZEPAM
DIAZEPAM INTENSOL
ENDEP
GASTROCROM
HALDOL
HALOPERIDOL
HALOPERIDOL
HALOPERIDOL
HALOPERIDOL
HALOPERIDOL
HALOPERIDOL
HALOPERIDOL
HALOPERIDOL INTENSOL
IMIPRAMINE HYDROCHLORIDE
LORAZEPAM
LORAZEPAM
LORAZEPAM
LORAZEPAM
LORAZEPAM
LORAZEPAM INTENSOL
LOXITANE C
MELLARIL
MELLARIL
METHADONE HYDROCHLORIDE INTENSOL
METHADOSE
METOCLOPRAMIDE INTENSOL
MOBAN
NAVANE
Applicant
NOVARTIS PHARMS CORP
SAGE PRODS
ROXANE
ACTAVIS MID ATLANTIC
PHARM ASSOC
PHARM ASSOC
WOCKHARDT
WOCKHARDT
ROXANE
ROXANE
GLAXOSMITHKLINE
GENERA PHARMS
MICRO LABS LTD INDIA
PACK PHARMS LLC
ROXANE
ROXANE
PHARM ASSOC
SILARX
TEVA PHARMS
WOCKHARDT
ROCHE
PHARM ASSOC
TEVA PHARMS
MEDA PHARMS
ORTHO MCNEIL
ALPHARMA
MORTON GROVE
PHARM ASSOC
SCS
SILARX
TEVA
TEVA PHARMS
ROXANE
NOVARTIS
AMNEAL PHARMS
HI‐TECH PHARMA CO
LUPIN LTD
PADDOCK LLC
PHARM ASSOC
ROXANE
WATSON LABS
NOVARTIS
NOVARTIS
ROXANE
VISTAPHARM
ROXANE
MALLINCKRODT
ROXANE
ENDO PHARMS
PFIZER
ORLAAM
PERMITIL
PERPHENAZINE
PROCHLORPERAZINE
PROKETAZINE
PROLIXIN
PROPRANOLOL HYDROCHLORIDE INTENSOL
SERENTIL
SINEQUAN
SONAZINE
SONAZINE
SPARINE
SPARINE
STELAZINE
TARACTAN
THIORIDAZINE HYDROCHLORIDE INTENSOL
THIORIDAZINE HYDROCHLORIDE INTENSOL
THIOTHIXENE HYDROCHLORIDE INTENSOL
ROXANE
SCHERING
PHARM ASSOC
ALPHARMA US PHARMS
MORTON GROVE
WYETH AYERST
APOTHECON
ROXANE
NOVARTIS
AUROBINDO PHARMA
RANBAXY LABS LTD
ROXANE
PFIZER
SANDOZ
SANDOZ
WYETH AYERST
WYETH AYERST
GLAXOSMITHKLINE
ROCHE
ALPHARMA US PHARMS
ANI PHARMS INC
HI TECH PHARMA
HI TECH PHARMA
PHARM ASSOC
PHARM ASSOC
SANDOZ
SANDOZ
TEVA PHARMS
WOCKHARDT
WOCKHARDT
ROXANE
ROXANE
ALPHARMA US PHARMS
PACO
PACO
TEVA
TEVA PHARMS
CYCLE PHARMS LTD
THORAZINE
GLAXOSMITHKLINE
THORAZINE
TRILAFON
ZOLOFT
GLAXOSMITHKLINE
SANDOZ
WOCKHARDT
SCHERING
PFIZER
FOUGERA PHARMS
Strength
150MG
2%
1MG/ML
100MG/ML
30MG/ML
100MG/ML
30MG/ML
100MG/ML
30MG/ML
100MG/ML
EQ 10MG BASE/ML
100MG/5ML
100MG/5ML
100MG/5ML
1MG/ML
5MG/ML
5MG/ML
EQ 10MG BASE/ML
EQ 10MG BASE/ML
EQ 10MG BASE/ML
EQ 10MG BASE/ML
40MG/ML
5MG/ML
5MG/ML
100MG/5ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 2MG BASE/ML
25MG/ML
2MG/ML
2MG/ML
2MG/ML
2MG/ML
2MG/ML
2MG/ML
EQ 25MG BASE/ML
30MG/ML
100MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
EQ 10MG BASE/ML
20MG/ML
EQ 5MG BASE/ML
10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
5MG/ML
16MG/5ML
EQ 10MG BASE/ML
EQ 10MG BASE/ML
50MG/ML
5MG/ML
80MG/ML
EQ 25MG BASE/ML
EQ 20MG BASE/ML
EQ 20MG BASE/ML
EQ 20MG BASE/ML
EQ 10MG BASE/ML
30MG/ML
100MG/ML
30MG/ML
100MG/ML
EQ 10MG BASE/ML
100MG/5ML
100MG/ML
30MG/ML
100MG/ML
30MG/ML
100MG/ML
30MG/ML
100MG/ML
30MG/ML
100MG/ML
30MG/ML
30MG/ML
100MG/ML
30MG/ML
100MG/ML
EQ 5MG BASE/ML
EQ 1MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 10MG BASE/ML
EQ 10MG BASE/ML
16MG/5ML
EQ 20MG BASE/ML
EQ 0.05% BASE
Page 00119
Appl_Type
N
N
A
A
A
A
A
A
A
A
N
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
A
A
A
N
A
N
N
205755
1
21669
1
74312
1
86863
1
40231
1
40224
1
87032
1
87053
1
88157
1
88158
1
11276
1
90954
1
202745
1 AA
202583
1 AA
88252
1
204433
1 AA
71415
1 AA
75924
1
74721
1 AA
71609
1 AA
71918
1 AA
85749
1
74725
1
73058
1
20479
1 AA
15922
1
70318
1
70710
1
73037
1 AA
70726
1
73364
1 AA
71015
1
71617
1 AA
72045
1
86765
1
91383
1 AA
200169
1 AA
91407
1 AA
79244
1 AA
90260
1 AA
72755
1 AA
17658
1
11808
12
11808
18
40180
1 AA
40088
1 AA
89897
1 AA
17116
2 AA
72995
1
17938
1
16758
1
N
N
A
A
A
N
A
A
N
A
A
A
N
A
A
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
20315
16008
40360
87153
88598
14173
70533
71388
16997
78861
78053
76934
17516
80983
80983
10942
10942
11552
16149
88229
87766
89603
40125
40126
40187
40213
88307
88308
89602
88258
88227
88941
88942
70969
71917
71939
71184
71554
73494
N
9149
N
A
A
N
N
A
9149
85787
88143
11557
20990
76215
29‐Apr‐14
25‐Apr‐05
31‐Oct‐93
30‐Dec‐99
26‐Jan‐99
8‐Jul‐82
27‐Apr‐83
27‐Apr‐83
18‐Dec‐09
4‐Apr‐13
27‐Oct‐11
1‐Sep‐83
14‐Apr‐14
3‐Apr‐87
15‐Jan‐04
29‐Dec‐98
9‐Nov‐87
20‐Jul‐88
16‐Sep‐96
30‐Aug‐91
29‐Feb‐96
11‐Apr‐86
7‐Mar‐86
26‐Feb‐93
10‐Jun‐86
28‐Sep‐93
25‐Aug‐87
1‐Dec‐88
12‐Apr‐88
23‐Dec‐09
30‐Jan‐12
19‐Feb‐13
28‐Apr‐09
15‐Jun‐10
28‐Jun‐91
30‐Apr‐98
30‐Nov‐94
6‐Sep‐88
30‐Jan‐92
RLD
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
Yes
No
Yes
No
No
Yes
No
No
Yes
No
Yes
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
Yes
No
No
No
Type
RX
OTC
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
DISCN
RX
DISCN
RX
DISCN
DISCN
DISCN
RX
DISCN
RX
DISCN
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
Applicant_Full_Name
SAGE PRODUCTS INC
ACTAVIS MID ATLANTIC LLC
PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
WOCKHARDT EU OPERATIONS (SWISS) AG
GLAXOSMITHKLINE
GENERA PHARMACEUTICALS LLC
MICRO LABS LTD INDIA
PACK PHARMACEUTICALS LLC
PHARMACEUTICAL ASSOC INC
SILARX PHARMACEUTICALS INC
ORTHO MCNEIL PHARMACEUTICAL
ALPHARMA USPD INC
MORTON GROVE PHARMACEUTICALS INC
SCS PHARMACEUTICALS
SILARX PHARMACEUTICALS INC
HI‐TECH PHARMACAL CO INC
LUPIN LTD
VISTAPHARM INC
PFIZER INC
9‐Jul‐93
25‐May‐01
8‐Jun‐82
25‐Oct‐84
7‐Nov‐85
15‐May‐87
31‐Oct‐08
5‐Feb‐07
30‐Jun‐06
23‐Aug‐83
26‐Apr‐83
9‐Nov‐87
16‐Aug‐96
16‐Aug‐96
28‐Aug‐97
29‐May‐98
23‐Nov‐83
23‐Nov‐83
9‐Nov‐87
25‐Jul‐83
5‐Jul‐83
16‐Dec‐85
16‐Dec‐85
16‐Oct‐87
20‐Sep‐89
16‐Dec‐88
22‐Jun‐87
16‐Oct‐87
30‐Jun‐92
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
SANDOZ INC
SANDOZ INC
GLAXOSMITHKLINE
HI TECH PHARMACAL CO INC
SANDOZ INC
SANDOZ INC
PACO RESEARCH CORP
PACO RESEARCH CORP
32
No
DISCN GLAXOSMITHKLINE
43
1
1
1
1 AA
1 AB
15‐Apr‐82
26‐Jul‐83
7‐Dec‐99
9‐Dec‐03
No
No
No
No
Yes
No
DISCN
DISCN
DISCN
DISCN
RX
RX
1
1
1
1
1
1
1
1
1
1 AA
1
1
1
4
5
1
4
6
2
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Approval_Date
GLAXOSMITHKLINE
SANDOZ INC
FOUGERA PHARMACEUTICALS INC
Page 00120
Ingredient
MICONAZOLE NITRATE
MICONAZOLE NITRATE
MICONAZOLE NITRATE
MICONAZOLE NITRATE
MICONAZOLE NITRATE
MICONAZOLE NITRATE
MICONAZOLE NITRATE
MICONAZOLE NITRATE
CLOTRIMAZOLE
CLOTRIMAZOLE
CLOTRIMAZOLE
DOCOSANOL
ALCLOMETASONE DIPROPIONATE
MASOPROCOL
ADAPALENE
ACRISORCIN
HYDROCORTISONE
IMIQUIMOD
HYDROCORTISONE; UREA
AMCINONIDE
AMCINONIDE
AMMONIUM LACTATE
AMMONIUM LACTATE
AMMONIUM LACTATE
AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE
AVOBENZONE; ECAMSULE; OCTOCRYLENE
HYDROCORTISONE
TAZAROTENE
TRETINOIN
AZELAIC ACID
MUPIROCIN CALCIUM
MONOBENZONE
CALCIPOTRIENE
HYDROCORTISONE; UREA
NYSTATIN
AVOBENZONE; ECAMSULE; OCTOCRYLENE
FLUOROURACIL
HYDROCORTISONE ACETATE; UREA
BETAMETHASONE
CHLORAMPHENICOL
CICLOPIROX
CICLOPIROX
CICLOPIROX
CICLOPIROX
CICLOPIROX
CLOCORTOLONE PIVALATE
CLOTRIMAZOLE
CLOTRIMAZOLE
CLOTRIMAZOLE
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE
FLURANDRENOLIDE
FLURANDRENOLIDE
FLURANDRENOLIDE; NEOMYCIN SULFATE
DF;Route
CREAM, SUPPOSITORY;TOPICAL, VAGINAL
CREAM, TABLET;TOPICAL, VAGINAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
Page 00121
Trade_Name
DIPROLENE
DIPROLENE AF
M‐ZOLE 3 COMBINATION PACK
M‐ZOLE 7 DUAL PACK
MICONAZOLE 7 COMBINATION PACK
MICONAZOLE NITRATE
MICONAZOLE NITRATE COMBINATION PACK
MONISTAT 1 COMBINATION PACK
MONISTAT‐3 COMBINATION PACK
GYNE‐LOTRIMIN 3 COMBINATION PACK
GYNE‐LOTRIMIN COMBINATION PACK
MYCELEX‐7 COMBINATION PACK
ABREVA
ACLOVATE
ACTINEX
ADAPALENE
AKRINOL
ALA‐CORT
ALDARA
ALPHADERM
ALPHATREX
AMCINONIDE
AMCINONIDE
AMMONIUM LACTATE
AMMONIUM LACTATE
AMMONIUM LACTATE
ANTHELIOS 20
ANTHELIOS 40
ANTHELIOS 40
ANTHELIOS SX
ANUSOL HC
ARISTOCORT
ARISTOCORT
ARISTOCORT
ARISTOCORT A
ARISTOCORT A
ARISTOCORT A
ARISTOCORT A
ARISTOCORT A
ARISTOCORT A
AVAGE
AVITA
AZELEX
BACTROBAN
BENOQUIN
BETA‐VAL
BETADERM
BETATREX
CALCIPOTRIENE
CALMURID HC
CANDEX
CAPITAL SOLEIL 15
CARAC
CARMOL HC
CELESTONE
CHLOROMYCETIN
CICLOPIROX
CICLOPIROX
CICLOPIROX
CICLOPIROX
CICLOPIROX
CLOBETASOL PROPIONATE (EMOLLIENT)
CLODERM
CLOTRIMAZOLE
CLOTRIMAZOLE
CLOTRIMAZOLE
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
CORDRAN SP
CORDRAN SP
CORDRAN‐N
Applicant
GLENMARK GENERICS
PERRIGO NEW YORK
TARO
TOLMAR
SCHERING
MERCK SHARP DOHME
G AND W LABS
PERRIGO R AND D
PERRIGO
INSIGHT PHARMS
INSIGHT PHARMS
INSIGHT PHARMS
SCHERING PLOUGH
GLAXOSMITHKLINE
FOUGERA PHARMS
UNIV AZ CANCER CTR
FOUGERA PHARMS
SCHERING
CROWN LABS
FOUGERA PHARMS
GLENMARK GENERICS
TARO
MEDICIS
BIOGLAN
SAVAGE LABS
FOUGERA PHARMS
TARO PHARM INDS
PERRIGO NEW YORK
TARO
WATSON LABS INC
LOREAL USA
LOREAL USA
LOREAL USA
LOREAL USA
SALIX PHARMS
ASTELLAS
ASTELLAS
ASTELLAS
ASTELLAS
ASTELLAS
ASTELLAS
ASTELLAS
ASTELLAS
ASTELLAS
ALLERGAN
MYLAN PHARMS INC
ALLERGAN
GLAXOSMITHKLINE
VALEANT PHARM INTL
TEVA
ROACO
FOUGERA PHARMS
PERRIGO NEW YORK
PERRIGO NEW YORK
PHARMADERM
TARO
TARO
TEVA
FOUGERA
PERRIGO NEW YORK
PHARMADERM
PHARMAFAIR
TARO
SAVAGE LABS
TOLMAR
BAYER PHARMS
LOREAL USA
VALEANT BERMUDA
FOUGERA PHARMS
SCHERING
PARKE DAVIS
FOUGERA PHARMS
G AND W LABS INC
GLENMARK PHARMS
PERRIGO
TARO
FOUGERA
G AND W LABS INC
RENAISSANCE PHARMA
TARO
TEVA PHARMS USA
FOUGERA PHARMS
RENAISSANCE PHARMA
TARO
PROMIUS PHARMA LLC
FOUGERA PHARMS
GLENMARK PHARMS
TARO
FOUGERA PHARMS
TARO
AQUA PHARMS
AQUA PHARMS
LILLY
Strength
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE
2%,200MG
2%,100MG
2%,100MG
2%,1.2GM
2%,200MG
2%,1.2GM
2%,100MG
2%,200MG
1%,200MG
1%,100MG
1%,100MG
10%
0.05%
10%
0.10%
2MG/GM
1%
0.05%
0.05%
0.05%
5%
1%;10%
EQ 0.05% BASE
0.10%
0.10%
EQ 12% BASE
EQ 12% BASE
EQ 12% BASE
2%;2%;10%;2%
2%;3%;10%;5%
2%;3%;10%;5%
2%;2%;10%
2.50%
0.03%
0.10%
0.50%
0.03%
0.03%
0.10%
0.10%
0.50%
0.50%
0.10%
0.03%
20%
EQ 2% BASE
20%
EQ 0.1% BASE
EQ 0.1% BASE
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.1% BASE
EQ 0.1% BASE
EQ 0.1% BASE
EQ 0.1% BASE
EQ 0.1% BASE
EQ 0.1% BASE
0.01%
1%;10%
100,000 UNITS/GM
2%;3%;10%
0.50%
1%;10%
0.20%
1%
0.77%
0.77%
0.77%
0.77%
0.77%
0.05%
0.05%
0.05%
0.05%
0.05%
0.05%
0.05%
0.05%
0.10%
1%
1%
1%
EQ 0.05% BASE;1%
EQ 0.05% BASE;1%
EQ 0.05% BASE;1%
0.03%
0.05%
0.05%;EQ 3.5MG BASE/GM
Page 00122
Appl_Type
A
A
A
A
N
N
A
A
A
A
A
N
N
N
N
N
N
N
N
N
A
N
A
A
A
A
N
A
N
A
A
A
A
A
N
N
N
N
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
A
N
A
A
N
A
A
A
N
A
N
A
A
N
A
A
A
N
N
A
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
N
A
A
A
A
A
A
N
N
N
78930
1 AB
76592
1 AB
76543
1 AB
76603
1 AB
19408
1
19555
1 AB
74926
1
74586
1
76585
1
79114
1
75329
1
21308
1
20288
2
20670
2
20526
2
20289
2
20389
2
20941
1
18707
1 AB
19940
1
90824
1 AB
12470
1
80706
6 AT
76973
1 AB
79061
1 AB
76587
1 AB
20723
1 AB
86008
1
19138
1
76065
1 AB
76229
1 AB
75774
1 AB
75883
1 AB
76829
1 AB
21471
1
22009
1
22009
2
21502
1
88250
1 AT
83017
3
83016
4
83015
2
83017
4
88818
1
83016
5
88819
1
83015
3
88820
1
21184
3
20404
3 AB
20428
1
50746
1 AB
8173
3
18642
1 AB
18839
1
70885
1 AB
19137
1 AB
72536
1
74579
1
19136
1
71143
1
73552
1 AB
71476
1
18861
1 AB
70053
1
18860
2
70485
1
70062
1
18862
1
200935
1 AB
83947
1
61810
1
21501
1
20985
1
80505
1
14762
1
50183
1
76435
1 AB
78463
1 AB
90273
1 AB
77364
1 AB
76790
1 AB
74392
1 AB1
74139
1
75338
1
74249
1 AB1
74087
1
75430
1 AB2
75733
1
75633
1 AB2
17765
1
78338
1 AB
90219
1 AB
72640
1 AB
76002
1 AB
75502
1 AB
75673
1 AB
12806
3
12806
2
50346
1
Approval_Date
23‐Sep‐08
9‐Dec‐03
9‐Dec‐03
23‐Jan‐04
31‐Jan‐86
27‐Apr‐87
16‐Apr‐99
17‐Jul‐97
26‐Mar‐04
2‐Jun‐10
20‐Apr‐99
29‐Jun‐01
26‐Apr‐93
16‐Apr‐96
29‐Jul‐96
26‐Apr‐93
23‐Jun‐94
25‐Jul‐00
14‐Dec‐82
4‐Sep‐92
30‐Jun‐10
12‐Jul‐05
23‐Jun‐09
15‐Sep‐05
27‐Feb‐97
26‐Jun‐84
15‐May‐03
31‐May‐02
1‐May‐02
10‐Apr‐03
7‐Feb‐06
5‐Oct‐06
31‐Mar‐08
29‐Oct‐09
21‐Jul‐06
6‐Jun‐84
16‐Oct‐84
16‐Oct‐84
16‐Oct‐84
30‐Sep‐02
14‐Jan‐97
13‐Sep‐95
11‐Dec‐97
24‐Mar‐83
30‐Jun‐83
3‐Feb‐87
26‐Jun‐84
31‐Jan‐90
26‐Nov‐97
26‐Jun‐84
17‐Jun‐87
30‐Apr‐92
10‐Aug‐87
31‐Aug‐83
10‐Jun‐86
31‐Aug‐83
29‐May‐87
14‐May‐85
31‐Aug‐83
30‐May‐12
2‐Oct‐06
27‐Oct‐00
29‐Dec‐04
20‐Dec‐10
10‐Nov‐09
3‐Mar‐06
12‐Apr‐05
30‐Sep‐96
3‐Aug‐94
9‐Feb‐01
8‐Jul‐96
16‐Feb‐94
26‐May‐99
22‐Aug‐01
17‐May‐00
2‐Sep‐08
3‐Aug‐10
31‐Aug‐93
2‐Aug‐02
5‐Jun‐01
29‐May‐01
RLD
No
No
No
No
No
Yes
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
No
Yes
Yes
No
No
No
No
No
No
No
Yes
No
No
Yes
No
No
No
No
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
Yes
No
Yes
Yes
No
No
No
No
Yes
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
Yes
No
No
No
Yes
Yes
No
Type
RX
RX
RX
RX
DISCN
RX
OTC
DISCN
OTC
OTC
OTC
OTC
OTC
OTC
OTC
OTC
OTC
OTC
RX
DISCN
RX
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
OTC
OTC
OTC
OTC
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
RX
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
OTC
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
DISCN
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
Applicant_Full_Name
PERRIGO NEW YORK INC
TARO PHARMACEUTICALS USA INC
TOLMAR INC
G AND W LABORATORIES INC
PERRIGO R AND D CO
PERRIGO CO
INSIGHT PHARMACEUTICALS CORP
GLAXOSMITHKLINE
UNIV ARIZONA CANCER CENTER
CROWN LABORATORIES INC
BIOGLAN LABORATORIES LTD
LOREAL USA PRODUCTS INC
ALLERGAN INC
ALLERGAN INC
GLAXOSMITHKLINE
TJ ROACO LTD
PHARMADERM DIV ALTANA INC
E FOUGERA DIV ALTANA INC
PHARMAFAIR INC
TOLMAR INC
PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
GLENMARK PHARMACEUTICALS INC USA
PERRIGO CO
RENAISSANCE PHARMA US HOLDINGS INC
PROMIUS PHARMA LLC
GLENMARK PHARMACEUTICALS INC USA
ELI LILLY AND CO
Page 00123
Ingredient
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
AMCINONIDE
AMCINONIDE
PENCICLOVIR SODIUM
HYDROCORTISONE
PREDNICARBATE
DESONIDE
DESONIDE
DESONIDE
DESONIDE
DESOXIMETASONE
DESOXIMETASONE
ADAPALENE
DIFLORASONE DIACETATE
CALCIPOTRIENE
ECONAZOLE NITRATE
ECONAZOLE NITRATE
ECONAZOLE NITRATE
ECONAZOLE NITRATE
FLUOROURACIL
HYDROCORTISONE
HYDROCORTISONE
PIMECROLIMUS
PERMETHRIN
MOMETASONE FUROATE
MOMETASONE FUROATE
LIDOCAINE; PRILOCAINE
SERTACONAZOLE NITRATE
CROTAMITON
SULCONAZOLE NITRATE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
FLUOCINOLONE ACETONIDE
FLUOCINONIDE
FLUOCINONIDE
FLUOCINONIDE
FLUOCINONIDE
FLUOCINONIDE
FLUOCINONIDE
FLUOCINONIDE
FLUOCINONIDE
FLUOCINONIDE
FLUOCINONIDE
FLUOCINONIDE
FLUOCINONIDE
FLUOCINONIDE
FLUOCINONIDE
FLUOROURACIL
FLUOROURACIL
FLUOROURACIL
AMPHOTERICIN B
NITROFURAZONE
GENTAMICIN SULFATE
GENTAMICIN SULFATE
GENTAMICIN SULFATE
GENTAMICIN SULFATE
GENTAMICIN SULFATE
GENTAMICIN SULFATE
GENTAMICIN SULFATE
DF;Route
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
Page 00124
Trade_Name
CORMAX
CORT‐DOME
CORT‐DOME
CORTISPORIN
CUTIVATE
CYCLOCORT
CYCLOCORT
DECADRON
DENAVIR
DERMABET
DERMACORT
DERMATOP E EMOLLIENT
DESONIDE
DESONIDE
DESONIDE
DESOWEN
DESOXIMETASONE
DESOXIMETASONE
DIFFERIN
DIPROSONE
DOVONEX
ECONAZOLE NITRATE
ECONAZOLE NITRATE
ECONAZOLE NITRATE
ECONAZOLE NITRATE
EFUDEX
ELDECORT
ELDECORT
ELIDEL
ELIMITE
ELOCON
ELOCON
EMBELINE E
EMLA
ERTACZO
EURAX
EXELDERM
FLEXICORT
FLEXICORT
FLEXICORT
FLORONE
FLORONE E
FLUOCET
FLUOCINONIDE
FLUOCINONIDE
FLUOCINONIDE
FLUOCINONIDE
FLUOCINONIDE
FLUOCINONIDE
FLUOCINONIDE
FLUOCINONIDE
FLUOCINONIDE
FLUOCINONIDE
FLUOCINONIDE EMULSIFIED BASE
FLUONID
FLUOROPLEX
FLUOROURACIL
FLUOROURACIL
FLUOTREX
FLUOTREX
FLUTEX
FLUTEX
FLUTEX
FUNGIZONE
FURACIN
GARAMYCIN
GENTAFAIR
GENTAMICIN SULFATE
GENTAMICIN SULFATE
GENTAMICIN SULFATE
GENTAMICIN SULFATE
GENTAMICIN SULFATE
Applicant
HI TECH PHARMA
BAYER PHARMS
BAYER PHARMS
MONARCH PHARMS
FOUGERA PHARMS
ASTELLAS
ASTELLAS
MERCK
DENCO ASSET
TARO
MONARCH PHARMS
VALEANT BERMUDA
PERRIGO NEW YORK
TARO
TEVA PHARMS
GALDERMA LABS LP
FOUGERA PHARMS
PERRIGO NEW YORK
GALDERMA LABS LP
FOUGERA PHARMS
FOUGERA PHARMS
TARO
SCHERING
LEO PHARMA AS
FOUGERA PHARMS
IGI LABS INC
PERRIGO NEW YORK
TARO
VALEANT PHARM INTL
VALEANT PHARM INTL
VALEANT PHARM INTL
VALEANT BERMUDA
RENAISSANCE PHARMA
MERCK SHARP DOHME
MERCK SHARP DOHME
HI TECH PHARMA
WATSON LABS INC
VALEANT LUXEMBOURG
RANBAXY
RANBAXY
WESTWOOD SQUIBB
WESTWOOD SQUIBB
WESTWOOD SQUIBB
ALPHARMA US PHARMS
ALPHARMA US PHARMS
FOUGERA
FOUGERA
G AND W LABS
G AND W LABS
PERRIGO NEW YORK
PERRIGO NEW YORK
PHARMADERM
PHARMADERM
PHARMAFAIR
PHARMAFAIR
TARO
TARO
TARO
TARO
USL PHARMA
USL PHARMA
FOUGERA
FOUGERA PHARMS INC
G AND W LABS INC
GLENMARK GENERICS
PERRIGO ISRAEL
PERRIGO NEW YORK
TARO
TARO
TARO
TEVA
FOUGERA PHARMS
G AND W LABS INC
TARO
TEVA
ALLERGAN HERBERT
AQUA PHARMS
SPEAR PHARMS
TARO
SAVAGE LABS
SAVAGE LABS
IVAX PHARMS
IVAX PHARMS
IVAX PHARMS
FOUGERA PHARMS
G AND W LABS
NESHER PHARMS
PERRIGO NEW YORK
TOLMAR
APOTHECON
SHIRE
SCHERING
PHARMAFAIR
ALPHARMA US PHARMS
BAUSCH AND LOMB
FOUGERA
PERRIGO NEW YORK
PHARMADERM
Strength
0.05%
0.50%
1%
0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
0.05%
0.03%
0.10%
EQ 0.1% PHOSPHATE
1%
EQ 0.1% BASE
1%
0.10%
0.05%
0.05%
0.05%
0.05%
0.25%
0.25%
0.10%
0.05%
0.05%
0.05%
EQ 0.05% BASE
0.01%
1%
1%
1%
1%
5%
1%
2.50%
1%
5%
0.10%
0.10%
0.05%
2.5%;2.5%
2%
10%
1%
0.50%
1%
2.50%
0.05%
0.05%
0.03%
0.01%
0.01%
0.03%
0.01%
0.03%
0.01%
0.03%
0.01%
0.03%
0.01%
0.03%
0.01%
0.01%
0.03%
0.03%
0.01%
0.03%
0.05%
0.10%
0.05%
0.10%
0.10%
0.05%
0.05%
0.05%
0.10%
0.05%
0.05%
0.05%
0.05%
0.05%
0.03%
1%
5%
5%
0.01%
0.03%
0.03%
0.10%
0.50%
0.05%
0.05%
0.05%
0.05%
0.05%
3%
0.20%
EQ 0.1% BASE
EQ 0.1% BASE
EQ 0.1% BASE
EQ 0.1% BASE
EQ 0.1% BASE
EQ 0.1% BASE
EQ 1MG BASE/GM
Page 00125
Appl_Type
A
N
N
N
N
N
N
N
N
A
A
N
N
A
A
N
A
A
N
A
A
A
N
N
A
A
A
A
N
A
A
N
N
N
N
A
N
N
N
N
A
A
A
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
A
A
A
A
A
A
A
N
A
A
A
A
A
A
A
A
A
A
A
A
N
A
A
A
A
A
A
A
A
74220
1 AB1
9585
3
9585
1
50218
1
19958
1
18116
1
18116
2
11983
2
20629
1
72041
1 AB
83011
2
20279
1 AB
17010
1 AB
73548
1 AB
74027
1
19048
1 AB
78369
1 AB
76510
1 AB
20748
1 AB
75187
1
76263
1 BX
75508
1 BX
17536
1
20554
1 AB
76075
1 AB
76574
1 AB
76479
1 AB
76005
1 AB
16831
3 AB
80459
1
84055
1
21302
1
19855
1 AB
19625
1 AB
19625
2 AB
75325
1 AB2
19941
1 AB
21385
1
6927
1
18737
1
87136
3
87136
2
87136
1
17741
1
19259
1
88360
1
88361
1
88170
1 AT
88169
1 AT
89526
1 AT
89525
1 AT
86810
1
86811
1
88047
1
88045
1
88499
1
88506
1
40035
1
87102
1
40042
1
87104
1 AT
88757
1
88756
1
73030
1 AB1
200735
1 AB
73085
1 AB1
91282
1 AB
90256
1 AB
71790
1
71500
1
19117
1 AB1
200734
1 AB
72488
1 AB1
76586
1 AB2
74204
1
72494
1 AB2
72490
1 AB2
87156
2
16988
1
77524
1 AB
90368
1 AB
88174
1
88173
1
85539
1
85539
2
85539
3
76451
1 AB
77055
1 AB
76865
1
76793
1 AB
76633
1 AB
50314
1
83789
1
60462
1
62458
1
62471
1
64056
1
62531
1 AT
62307
1 AT
62530
1
Approval_Date
16‐May‐97
9‐Aug‐85
18‐Dec‐90
24‐Sep‐96
6‐Jan‐88
29‐Oct‐93
30‐Jun‐92
28‐Sep‐92
14‐Dec‐84
29‐Jun‐10
1‐Jul‐03
26‐May‐00
30‐Mar‐98
20‐Dec‐02
24‐Apr‐00
22‐Jul‐96
26‐Nov‐02
17‐Dec‐04
23‐Jun‐04
26‐Nov‐02
13‐Dec‐01
25‐Aug‐89
6‐May‐87
19‐Apr‐13
24‐Dec‐98
30‐Dec‐92
10‐Dec‐03
28‐Feb‐89
8‐Apr‐82
8‐Apr‐82
8‐Apr‐82
28‐Aug‐85
16‐Jan‐84
16‐Jan‐84
16‐Dec‐82
16‐Dec‐82
26‐Jul‐88
26‐Jul‐88
4‐Mar‐82
4‐Mar‐82
16‐Dec‐82
16‐Dec‐82
2‐Aug‐84
2‐Aug‐84
31‐Oct‐94
27‐Apr‐82
31‐Oct‐94
27‐Apr‐82
11‐Feb‐85
28‐Mar‐85
17‐Oct‐94
14‐Jul‐14
14‐Feb‐92
14‐Jul‐14
14‐Jan‐14
13‐Jul‐88
10‐Jun‐87
26‐Jun‐84
14‐Jul‐14
6‐Feb‐89
23‐Jun‐04
13‐Jun‐95
19‐Jan‐89
7‐Feb‐89
6‐Sep‐84
11‐Apr‐08
5‐Mar‐10
6‐May‐83
9‐Mar‐83
14‐May‐04
30‐Jun‐06
10‐Sep‐04
14‐May‐04
14‐May‐04
1‐Sep‐83
27‐Sep‐83
29‐Apr‐94
5‐Jul‐84
5‐Jul‐84
RLD
No
No
No
Yes
No
No
No
No
Yes
No
No
Yes
Yes
No
No
No
No
No
Yes
No
Yes
Yes
No
Yes
Yes
No
No
No
Yes
No
No
Yes
Yes
Yes
No
No
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
Yes
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
Type
RX
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
RX
RX
RX
DISCN
RX
RX
RX
RX
DISCN
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
DISCN
RX
RX
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
Applicant_Full_Name
MONARCH PHARMACEUTICALS INC
MERCK AND CO INC
DENCO ASSET LLC
LEO PHARMA AS
IGI LABORATORIES INC
RANBAXY LABORATORIES INC
WESTWOOD SQUIBB PHARMACEUTICALS INC
PHARMAFAIR INC
PHARMAFAIR INC
USL PHARMA INC
USL PHARMA INC
PERRIGO ISRAEL PHARMACEUTICALS
ALLERGAN HERBERT DIV ALLERGAN INC
AQUA PHARMACEUTICALS LLC
SPEAR PHARMACEUTICALS INC
TOLMAR INC
PHARMAFAIR INC
BAUSCH AND LOMB PHARMACEUTICALS INC
Page 00126
Ingredient
GENTAMICIN SULFATE
HYDROCORTISONE
HALOBETASOL PROPIONATE
HALCINONIDE
HALCINONIDE
HALCINONIDE
HALOPROGIN
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE BUTYRATE
HYDROCORTISONE VALERATE
HYDROCORTISONE
HYDROCORTISONE
IMIQUIMOD
IMIQUIMOD
IMIQUIMOD
IMIQUIMOD
IMIQUIMOD
IMIQUIMOD
IMIQUIMOD
IMIQUIMOD
KETOCONAZOLE
KETOCONAZOLE
KETOCONAZOLE
LINDANE
LINDANE
AMMONIUM LACTATE
TERBINAFINE HYDROCHLORIDE
FLUOCINONIDE
FLUOCINONIDE
FLUMETHASONE PIVALATE
CICLOPIROX
CLOTRIMAZOLE
BUTENAFINE HYDROCHLORIDE
LULICONAZOLE
MECLOCYCLINE SULFOSALICYLATE
DF;Route
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
Page 00127
Trade_Name
GENTAMICIN SULFATE
H‐CORT
HALOG
HALOG
HALOG‐E
HALOTEX
HC #1
HC #4
HC (HYDROCORTISONE)
HC (HYDROCORTISONE)
HEMSOL‐HC
HI‐COR
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
HYTONE
HYTONE
IMIQUIMOD
IMIQUIMOD
IMIQUIMOD
IMIQUIMOD
IMIQUIMOD
IMIQUIMOD
IMIQUIMOD
IMIQUIMOD
KENALOG
KENALOG
KENALOG
KENALOG‐H
KETOCONAZOLE
KETOCONAZOLE
KETOZOLE
KWELL
KWELL
LAC‐HYDRIN
LAMISIL
LAMISIL
LIDEX
LIDEX‐E
LIDOCAINE AND PRILOCAINE
LOCOID
LOCOID
LOCOID LIPOCREAM
LOCORTEN
LOPROX
LOTRIMIN
LOTRIMIN ULTRA
LOTRISONE
LUZU
MECLAN
Applicant
TARO
PHARM ASSOC
FOUGERA PHARMS
G AND W LABS
PERRIGO ISRAEL
TARO
RANBAXY
WESTWOOD SQUIBB
RANBAXY
WESTWOOD SQUIBB
BAYER PHARMS
BAYER PHARMS
C AND M PHARMA
C AND M PHARMA
ABLE
C AND M PHARMA
ALPHARMA US PHARMS
ALTANA
ALTANA
AMBIX
AMBIX
EVERYLIFE
EVERYLIFE
FOUGERA
FOUGERA
G AND W LABS
INGRAM PHARM
INGRAM PHARM
IVAX PHARMS
LYNE
NASKA
PERRIGO NEW YORK
PERRIGO NEW YORK
PERRIGO NEW YORK
PHARMADERM
PHARMADERM
PHARMAFAIR
STIEFEL
SYOSSET
TARO
TARO
TARO
TEVA
TEVA
TEVA
TEVA
TOPIDERM
USL PHARMA
USL PHARMA
VINTAGE PHARMS
CENCI
FERNDALE LABS
PARKE DAVIS
PUREPAC PHARM
PUREPAC PHARM
GLENMARK GENERICS
TARO PHARM INDS
PERRIGO NEW YORK
TARO
TEVA PHARMS
VALEANT INTL
VALEANT INTL
APOTEX INC
FOUGERA PHARMS
GLENMARK GENERICS
PERRIGO ISRAEL
STRIDES PHARMA
TARO
TEVA PHARMS USA
TOLMAR
DELCOR ASSET CORP
DELCOR ASSET CORP
DELCOR ASSET CORP
DELCOR ASSET CORP
FOUGERA PHARMS
TEVA
TARO
REED AND CARNRICK
REED AND CARNRICK
RANBAXY
NOVARTIS
NOVARTIS
CNTY LINE PHARMS
CNTY LINE PHARMS
FOUGERA PHARMS
HI TECH PHARMA
TOLMAR
PRECISION DERMAT
YAMANOUCHI
PRECISION DERMAT
NOVARTIS
MEDIMETRIKS PHARMS
SCHERING PLOUGH
SCHERING PLOUGH
MERCK SHARP DOHME
MEDICIS
JOHNSON AND JOHNSON
Strength
EQ 0.1% BASE
0.50%
0.05%
0.05%
0.05%
0.05%
0.10%
0.03%
0.10%
1%
0.50%
1%
0.50%
1%
1%
2.50%
1%
2.50%
2.50%
0.50%
1%
1%
2.50%
0.50%
1%
1%
2.50%
1%
0.50%
1%
1%
2.50%
1%
0.50%
1%
2.50%
1%
2.50%
1%
1%
0.50%
0.50%
1%
2.50%
0.50%
1%
1%
2.50%
1%
1%
2.50%
2.50%
1%
1%
2.50%
1%
0.50%
1%
0.10%
0.10%
0.20%
0.20%
0.20%
1%
2.50%
5%
5%
5%
5%
5%
5%
5%
5%
0.03%
0.10%
0.50%
0.10%
2%
2%
2%
1%
1%
EQ 12% BASE
1%
1%
0.05%
0.05%
2.5%;2.5%
2.5%;2.5%
2.5%;2.5%
0.10%
0.10%
0.10%
0.03%
0.77%
1%
1%
EQ 0.05% BASE;1%
1%
1%
Page 00128
Appl_Type
A
A
A
A
A
A
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
A
A
A
A
A
A
N
N
N
N
N
N
A
A
A
N
N
N
N
N
N
N
N
N
N
62427
1 AT
86823
1
77001
1 AB
78162
1 AB
77123
1 AB
77227
1 AB
17556
1
17818
1
18234
1
16942
1
80438
1
80438
2
80482
3
80482
4
81274
1
80483
1
87795
1 AT
89682
1 AT
89754
1
80848
2
80848
3
86080
1
86271
1
80452
1
80452
2
80693
3 AT
89414
1 AT
84059
1
80456
2
80456
3
85733
1
40879
1 AT
89706
1
84970
2
85026
1
85025
1 AT
88845
1
89413
1
87838
1
86170
1
85527
1
86154
1
86155
1
88799
1 AT
80400
2
80400
3
85191
1
80400
4
89273
1
88027
1
88029
1
40503
1 AT
80496
2
80419
1
40259
1
89914
1
86050
1
86052
1
202145
1 AB2
76654
1 AB1
75666
1 AB
75042
1 AB
74489
1
80472
3
80472
4
91308
1 AB
78548
1 AB
201994
1 AB
78837
1 AB
202002
1 AB
200173
1 AB
200481
1 AB
91044
1 AB
11601
3
11601
6
83943
1
86240
1
76294
1 AB
75581
1 AB
75638
1 AB
84218
1
6309
1
20508
1 AB
20192
1
20980
1
16908
2
16908
3
76453
1 AB
76290
1 AB
76320
1 AB
18514
1 AB1
18795
1
20769
1 AB2
16379
1
18748
1 AB
17619
1
21307
1
18827
1 AB
204153
1
50518
1
Approval_Date
26‐May‐83
16‐Dec‐04
24‐Apr‐07
16‐Dec‐04
4‐Aug‐05
19‐Jun‐92
3‐May‐83
10‐Mar‐88
1‐Feb‐89
16‐Dec‐86
20‐Aug‐10
10‐Mar‐88
27‐Feb‐86
16‐Dec‐86
28‐Jul‐82
9‐Nov‐84
17‐Feb‐89
27‐Sep‐83
27‐Sep‐83
12‐Mar‐04
25‐Jan‐82
29‐Jul‐99
3‐Jan‐89
27‐Sep‐13
3‐Aug‐05
24‐May‐00
25‐Aug‐98
12‐Aug‐98
6‐Apr‐12
25‐Feb‐10
6‐Mar‐12
7‐Sep‐10
24‐Jun‐14
15‐Apr‐11
18‐Apr‐11
28‐Feb‐11
28‐Apr‐04
25‐Apr‐00
18‐Dec‐02
29‐Aug‐96
30‐Dec‐92
9‐Mar‐99
18‐Aug‐03
25‐Sep‐03
27‐Aug‐03
31‐Mar‐82
7‐Jan‐83
8‐Sep‐97
30‐Dec‐82
7‐Dec‐01
10‐Jul‐84
14‐Nov‐13
RLD
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
Yes
No
Yes
No
No
No
No
No
Yes
No
Yes
No
Yes
No
Yes
Yes
Yes
No
Type
RX
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
RX
DISCN
OTC
DISCN
DISCN
RX
RX
RX
RX
DISCN
RX
DISCN
RX
DISCN
OTC
RX
RX
DISCN
Applicant_Full_Name
C AND M PHARMACAL INC
ALTANA INC
ALTANA INC
AMBIX LABORATORIES DIV ORGANICS CORP AMERICA
EVERYLIFE
EVERYLIFE
INGRAM PHARMACEUTICAL CO
INGRAM PHARMACEUTICAL CO
LYNE LABORATORIES INC
NASKA PHARMACAL CO INC DIV RUGBY DARBY GROUP COSMETICS
PHARMAFAIR INC
SYOSSET LABORATORIES INC
TOPIDERM INC
USL PHARMA INC
USL PHARMA INC
HR CENCI LABORATORIES INC
FERNDALE LABORATORIES INC
TARO PHARMACEUTICALS, INC.
APOTEX INC
TOLMAR INC
DELCOR ASSET CORP
DELCOR ASSET CORP
DELCOR ASSET CORP
DELCOR ASSET CORP
REED AND CARNRICK PHARMACEUTICALS DIV BLOCK DRUG CO INC
REED AND CARNRICK PHARMACEUTICALS DIV BLOCK DRUG CO INC
TOLMAR INC
YAMANOUCHI EUROPE BV
MEDIMETRIKS PHARMACEUTICALS INC
JOHNSON AND JOHNSON CONSUMER COMPANIES INC
Page 00129
Ingredient
PREDNISOLONE
METRONIDAZOLE
METRONIDAZOLE
METRONIDAZOLE
METHYL AMINOLEVULINATE HYDROCHLORIDE
MOMETASONE FUROATE
MOMETASONE FUROATE
MOMETASONE FUROATE
MOMETASONE FUROATE
MOMETASONE FUROATE
MICONAZOLE NITRATE
MUPIROCIN CALCIUM
CLOTRIMAZOLE
NYSTATIN; TRIAMCINOLONE ACETONIDE
NYSTATIN
NYSTATIN
NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE
NAFTIFINE HYDROCHLORIDE
HYDROCORTISONE; NEOMYCIN SULFATE
HYDROCORTISONE; NEOMYCIN SULFATE
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE
METHYLPREDNISOLONE ACETATE; NEOMYCIN SULFATE
METHYLPREDNISOLONE ACETATE; NEOMYCIN SULFATE
FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE
NEOMYCIN SULFATE; POLYMYXIN B SULFATE
NYSTATIN
KETOCONAZOLE
HYDROCORTISONE
METRONIDAZOLE
HYDROCORTISONE
HYDROCORTISONE
NYSTATIN
NYSTATIN
NYSTATIN
NYSTATIN
NYSTATIN
NYSTATIN
NYSTATIN
OXICONAZOLE NITRATE
FLUOROMETHOLONE
HYDROCORTISONE PROBUTATE
HYDROCORTISONE
PERMETHRIN
PERMETHRIN
LIDOCAINE; TETRACAINE
PREDNICARBATE
HYDROCORTISONE
TRETINOIN
TRETINOIN
TRETINOIN
TRETINOIN
TRETINOIN
SILVER SULFADIAZINE
ECONAZOLE NITRATE
SILVER SULFADIAZINE
SILVER SULFADIAZINE
MAFENIDE ACETATE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
TAZAROTENE
TAZAROTENE
SILVER SULFADIAZINE
DESOXIMETASONE
DESOXIMETASONE
DESOXIMETASONE
DESOXIMETASONE
TRETINOIN
TRETINOIN
TRETINOIN
TRETINOIN
DF;Route
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
Page 00130
Trade_Name
MENTAX
MENTAX‐TC
METI‐DERM
METROCREAM
METRONIDAZOLE
METRONIDAZOLE
METVIXIA
MICORT‐HC
MICORT‐HC
MOMETASONE FUROATE
MOMETASONE FUROATE
MOMETASONE FUROATE
MOMETASONE FUROATE
MOMETASONE FUROATE
MONISTAT‐DERM
MUPIROCIN
MYCELEX
MYCO‐TRIACET II
MYCOLOG‐II
MYCOLOG‐II
MYCOSTATIN
MYKACET
MYKINAC
MYTREX A
MYTREX F
NAFTIN
NAFTIN
NEO‐CORT‐DOME
NEO‐CORT‐DOME
NEO‐CORTEF
NEO‐CORTEF
NEO‐MEDROL ACETATE
NEO‐MEDROL ACETATE
NEO‐SYNALAR
NEOMYCIN SULFATE‐TRIAMCINOLONE ACETONIDE
NEOMYCIN SULFATE‐TRIAMCINOLONE ACETONIDE
NEOSPORIN
NILSTAT
NIZORAL
NOGENIC HC
NORITATE
NUTRACORT
NUTRACORT
NYSTATIN
NYSTATIN
NYSTATIN
NYSTATIN
NYSTATIN
NYSTATIN
NYSTATIN
NYSTATIN AND TRIAMCINOLONE ACETONIDE
NYSTATIN‐TRIAMCINOLONE ACETONIDE
OXISTAT
OXYLONE
PANDEL
PENECORT
PERMETHRIN
PERMETHRIN
PLIAGLIS
PRAMOSONE
PRAMOSONE
PREDNICARBATE
PROCTOCORT
PSORCON
RENOVA
RENOVA
RETIN‐A
RETIN‐A
RETIN‐A
SILVADENE
SPECTAZOLE
SSD
SSD AF
SULFAMYLON
SYNACORT
SYNACORT
SYNACORT
SYNALAR
SYNALAR
SYNALAR
SYNALAR‐HP
TAZORAC
TAZORAC
TEMOVATE
TEMOVATE E
THERMAZENE
TOPICORT
TOPICORT
TOPICORT
TOPICORT LP
TRETINOIN
TRETINOIN
TRETINOIN
TRETINOIN
Applicant
MYLAN
MYLAN
SCHERING
GALDERMA LABS LP
FOUGERA PHARMS
G AND W LABS
GALDERMA LABS LP
SEBELA IRELAND LTD
SEBELA IRELAND LTD
FOUGERA PHARMS
G AND W LABS
GLENMARK GENERICS
TARO
TOLMAR
INSIGHT PHARMS
GLENMARK GENERICS
TEVA
DELCOR ASSET CORP
DELCOR ASSET CORP
DELCOR ASSET CORP
G AND W LABS INC
ALPHARMA US PHARMS
SAVAGE LABS
SAVAGE LABS
MERZ PHARMS
MERZ PHARMS
BAYER PHARMS
BAYER PHARMS
MEDIMETRIKS PHARMS
FOUGERA
PHARMADERM
GLAXOSMITHKLINE
LEDERLE
JANSSEN PHARMA
IVAX PHARMS
VALEANT BERMUDA
DOW PHARM
DOW PHARM
FOUGERA PHARMS
PERRIGO NEW YORK
TARO
TARO
TEVA
VINTAGE
ALPHARMA US PHARMS
FOUGERA
PERRIGO NEW YORK
PHARMAFAIR
TARO
TARO
PHARMADERM
FOUGERA PHARMS
FOUGERA PHARMS
ALLERGAN HERBERT
PERRIGO NEW YORK
GALDERMA LABS LP
SEBELA IRELAND LTD
SEBELA IRELAND LTD
FOUGERA PHARMS
MONARCH PHARMS
TARO PHARMS NORTH
VALEANT INTL
VALEANT INTL
VALEANT BERMUDA
VALEANT BERMUDA
VALEANT BERMUDA
KING PHARMS
MERZ PHARMS LLC
DR REDDYS LA
DR REDDYS LA
MYLAN INSTITUTIONAL
MEDICIS
MEDICIS
MEDICIS
MEDIMETRIKS PHARMS
MEDIMETRIKS PHARMS
MEDIMETRIKS PHARMS
MEDIMETRIKS PHARMS
ALLERGAN
ALLERGAN
FOUGERA PHARMS
FOUGERA PHARMS
TARO
TARO
TARO
TARO PHARMS NORTH
TARO PHARMS NORTH
MATAWAN PHARMS
MATAWAN PHARMS
MATAWAN PHARMS
SUNEVA MEDCL
Strength
1%
1%
0.50%
0.75%
0.75%
0.75%
EQ 16.8% BASE
2%
2.50%
0.10%
0.10%
0.10%
0.10%
0.10%
2%
EQ 2% BASE
1%
100,000 UNITS/GM;0.1%
100,000 UNITS/GM;0.1%
100,000 UNITS/GM;0.1%
100,000 UNITS/GM
100,000 UNITS/GM;0.1%
100,000 UNITS/GM
EQ 3.5MG BASE/GM;0.1%
100,000 UNITS/GM;0.1%
1%
2%
1%;EQ 3.5MG BASE/GM
1%;EQ 3.5MG BASE/GM
1%;EQ 3.5MG BASE/GM
EQ 3.5MG BASE/GM;10,000 UNITS/GM
100,000 UNITS/GM
2%
1%
1%
0.50%
1%
100,000 UNITS/GM
100,000 UNITS/GM
100,000 UNITS/GM
100,000 UNITS/GM
100,000 UNITS/GM
100,000 UNITS/GM
100,000 UNITS/GM
100,000 UNITS/GM;0.1%
100,000 UNITS/GM;0.1%
100,000 UNITS/GM;0.1%
100,000 UNITS/GM;0.1%
100,000 UNITS/GM;0.1%
100,000 UNITS/GM;0.1%
100,000 UNITS/GM;0.1%
EQ 1% BASE
0.03%
0.10%
1%
5%
5%
7%;7%
0.5%;1%
1%;1%
0.10%
1%
0.05%
0.02%
0.05%
0.03%
0.05%
0.10%
1%
1%
1%
1%
EQ 85MG BASE/GM
0.50%
1%
2.50%
0.01%
0.03%
0.03%
0.20%
0.05%
0.10%
0.05%
0.05%
1%
1%
0.05%
0.25%
0.25%
0.05%
0.03%
0.05%
0.10%
0.05%
Page 00131
Appl_Type
N
N
N
N
A
A
N
A
A
A
A
A
A
A
N
A
N
A
A
A
A
A
A
A
A
N
N
N
N
A
A
A
A
A
A
A
N
A
N
A
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
A
A
A
N
A
A
A
A
N
N
N
N
N
N
N
N
N
N
N
A
A
A
N
N
N
N
N
N
N
N
A
N
A
A
N
N
A
A
A
A
20524
1
21408
1
10209
2
20531
1 AB
76408
1 AB
77549
1 AB
21415
1
40398
1
40396
1
76171
1 AB
77447
1 AB
78541
1 AB
76679
1 AB
76591
1 AB
17494
1
201587
1 AB
18183
1
61954
2
60576
2
62606
1
60575
1
62367
1
62387
1
62598
1
62597
1
19599
1
19599
2
50237
6
50237
5
61049
1
61049
2
60611
2
60611
1
60700
1
62600
1
62595
1
50176
2
61445
1
19084
1
87427
1
20743
1
80442
2
80442
3
62949
1 AT
62129
1 AT
62225
1 AT
62457
1
64022
1 AT
61966
1
65315
1 AT
63010
1
62599
1 AT
62186
2
62657
1
62347
1
62364
1 AT
62596
1
19828
1
11748
1
20453
1
88216
1
74806
1 AB
76369
1 AB
21717
1
83778
1
85368
1
77287
1 AB
83011
1
20205
1
21108
1
19963
1 AB2
19049
1 AB
17522
1 AB1
17340
1 AB
17381
1 AB
18751
1
18578
1 AB
18578
3 BX
16763
1
87459
1
87458
1 AT
87457
1 AT
12787
4 AT
12787
2 AT
12787
5 AT
16161
2
21184
1
21184
2
19322
1 AB1
20340
1 AB2
77511
1
18810
1 AB
73210
1
73193
1 AB
17856
1
18309
1
75264
1 AB
75265
1 AB1
75213
1 AB
76498
1 AB2
Approval_Date
18‐Oct‐96
17‐Oct‐02
20‐Sep‐95
28‐May‐04
19‐Dec‐07
27‐Jul‐04
29‐Mar‐02
27‐Feb‐01
8‐Apr‐05
22‐May‐06
28‐May‐08
21‐Dec‐04
18‐Apr‐07
24‐Jan‐13
20‐Sep‐85
1‐May‐85
15‐May‐85
28‐May‐85
29‐Jul‐82
21‐Jul‐86
8‐Oct‐85
29‐Feb‐88
13‐Jan‐12
5‐Jun‐84
5‐Jun‐84
21‐Jul‐86
21‐Jul‐86
14‐Jan‐85
31‐Dec‐85
4‐Apr‐88
26‐Sep‐97
13‐Jun‐88
28‐Jul‐83
29‐Jan‐93
31‐May‐06
20‐Dec‐88
8‐Oct‐85
6‐Jun‐85
30‐Jul‐86
30‐Mar‐87
22‐Dec‐87
8‐Oct‐85
30‐Dec‐88
28‐Feb‐97
6‐Jun‐84
23‐Jan‐98
21‐Apr‐03
29‐Jun‐06
19‐Sep‐06
20‐Nov‐92
31‐Aug‐00
29‐Dec‐95
16‐Sep‐88
23‐Dec‐82
25‐Feb‐82
11‐Jul‐90
29‐Sep‐00
29‐Sep‐00
27‐Dec‐85
17‐Jun‐94
2‐Jul‐07
23‐Dec‐85
30‐Nov‐90
30‐Nov‐90
24‐Dec‐98
24‐Dec‐98
24‐Dec‐98
15‐Sep‐05
RLD
Yes
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
No
No
No
No
No
Yes
No
No
No
No
No
No
Yes
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
Yes
No
Yes
No
Yes
No
No
No
Yes
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
Yes
No
No
No
Yes
Yes
Yes
No
Yes
Yes
Yes
Yes
No
No
Yes
Yes
No
No
No
No
No
No
Type
RX
DISCN
DISCN
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
RX
RX
RX
DISCN
RX
DISCN
RX
DISCN
RX
DISCN
DISCN
DISCN
RX
DISCN
RX
DISCN
RX
DISCN
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
OTC
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
Applicant_Full_Name
SEBELA IRELAND LTD
SEBELA IRELAND LTD
TOLMAR INC
DELCOR ASSET CORP
DELCOR ASSET CORP
DELCOR ASSET CORP
MERZ PHARMACEUTICALS LLC
GLAXOSMITHKLINE
JANSSEN PHARMACEUTICA PRODUCTS LP
PHARMAFAIR INC
SEBELA IRELAND LTD
SEBELA IRELAND LTD
TARO PHARMACEUTICALS NORTH AMERICA INC
DR REDDYS LABORATORIES LOUISIANA LLC
DR REDDYS LABORATORIES LOUISIANA LLC
MYLAN INSTITUTIONAL INC
ALLERGAN INC
ALLERGAN INC
MATAWAN PHARMACEUTICALS LLC
SUNEVA MEDICAL INC
Page 00132
Ingredient
TRETINOIN
TRETINOIN
FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN
TIOCONAZOLE
HYDROCORTISONE ACETATE; UREA
BETAMETHASONE BENZOATE
EFLORNITHINE HYDROCHLORIDE
FLUOCINONIDE
ACYCLOVIR; HYDROCORTISONE
ACYCLOVIR
IMIQUIMOD
IMIQUIMOD
MICONAZOLE NITRATE
MICONAZOLE NITRATE
MICONAZOLE NITRATE
ESTROGENS, CONJUGATED
SULFANILAMIDE
BUTOCONAZOLE NITRATE
CLOTRIMAZOLE
CLOTRIMAZOLE
DIENESTROL
DIENESTROL
ESTRADIOL
DIENESTROL
CLOTRIMAZOLE
CLOTRIMAZOLE
TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)
MICONAZOLE NITRATE
MICONAZOLE NITRATE
MICONAZOLE NITRATE
MICONAZOLE NITRATE
MICONAZOLE NITRATE
MICONAZOLE NITRATE
MICONAZOLE NITRATE
MICONAZOLE NITRATE
MICONAZOLE NITRATE
MICONAZOLE NITRATE
CLOTRIMAZOLE
ESTROPIPATE
SULFANILAMIDE
ESTROGENS, CONJUGATED SYNTHETIC A
TERCONAZOLE
TERCONAZOLE
TERCONAZOLE
TERCONAZOLE
DF;Route
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL
CREAM;TOPICAL, VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
Page 00133
Trade_Name
TRETINOIN
TRETINOIN
TRI‐LUMA
TRIACET
TRIACET
TRIACET
TRIACORT
TRIATEX
TRIATEX
TRIATEX
TRIDERM
TRYMEX
TRYMEX
TRYMEX
TZ‐3
U‐CORT
ULTRAVATE
UTICORT
VALISONE
VALISONE
VALNAC
VANIQA
VANOS
WESTCORT
XERESE
ZONALON
ZOVIRAX
ZYCLARA
ZYCLARA
MICONAZOLE 3 COMBINATION PACK
MONISTAT 3 COMBINATION PACK (PREFILLED)
PREMARIN
AVC
CLEOCIN
CLEOCIN
CLINDESSE
CLOTRIMAZOLE
CLOTRIMAZOLE
DIENESTROL
DV
ESTRACE
ESTRAGUARD
FEMSTAT
FEMSTAT 3
GYNAZOLE‐1
GYNE‐LOTRIMIN
GYNE‐LOTRIMIN 3
GYNE‐SULF
MICONAZOLE 3
MICONAZOLE 7
MICONAZOLE NITRATE
MICONAZOLE NITRATE
MICONAZOLE NITRATE
MICONAZOLE NITRATE
MICONAZOLE NITRATE
MICONAZOLE NITRATE
MONISTAT 3
MONISTAT 7
MYCELEX‐7
OGEN
SULFANILAMIDE
SULTRIN
SYNTHETIC CONJUGATED ESTROGENS A
TERAZOL 3
TERAZOL 7
TERCONAZOLE
TERCONAZOLE
Applicant
WATSON LABS INC
WATSON LABS INC
GALDERMA LABS LP
TEVA
TEVA
TEVA
SOLVAY
ALPHARMA US PHARMS
AMBIX
FOUGERA PHARMS
FOUGERA PHARMS
FOUGERA PHARMS
G AND W LABS
G AND W LABS
MORTON GROVE
MORTON GROVE
MORTON GROVE
PERRIGO NEW YORK
PERRIGO NEW YORK
PERRIGO NEW YORK
PHARMADERM
PHARMADERM
PHARMADERM
PHARMAFAIR
PHARMAFAIR
PHARMAFAIR
TARO
TARO
TARO
TARO
TARO
TOPIDERM
TOPIDERM
TOPIDERM
VINTAGE
VINTAGE
IVAX PHARMS
IVAX PHARMS
IVAX PHARMS
CROWN LABS
SAVAGE LABS
SAVAGE LABS
SAVAGE LABS
PFIZER
TARO
RANBAXY
PARKE DAVIS
SCHERING
SCHERING
SKINMEDICA
MEDICIS
RANBAXY
VALEANT BERMUDA
FOUGERA PHARMS
VALEANT BERMUDA
MEDICIS
MEDICIS
PERRIGO
INSIGHT PHARMS
INSIGHT PHARMS
WYETH PHARMS INC
MEDA PHARMS
PERRIGO ISRAEL
FOUGERA PHARMS
LUMARA HEALTH INC
TARO
ORTHO MCNEIL PHARM
SANOFI AVENTIS US
WARNER CHILCOTT US
SOLVAY
ROCHE PALO
BAYER
LUMARA HEALTH INC
SCHERING PLOUGH
SCHERING PLOUGH
G AND W LABS
TARO
G AND W LABS INC
PERRIGO
PERRIGO R AND D
TARO
TEVA
TEVA PHARMS
INSIGHT PHARMS
INSIGHT PHARMS
TEVA
ORTHO MCNEIL PHARM
TEVA WOMENS
JANSSEN PHARMS
JANSSEN PHARMS
FOUGERA PHARMS
NYCOMED US
Strength
0.04%
0.08%
0.01%;4%;0.05%
0.03%
0.10%
0.50%
0.10%
0.10%
0.03%
0.03%
0.03%
0.10%
0.50%
0.03%
0.10%
0.03%
0.10%
0.50%
0.03%
0.10%
0.50%
0.03%
0.10%
0.50%
0.03%
0.10%
0.50%
0.03%
0.03%
0.10%
0.10%
0.50%
0.03%
0.10%
0.50%
0.03%
0.10%
0.03%
0.10%
0.50%
0.10%
0.03%
0.10%
0.50%
1%
1%;10%
0.05%
0.03%
EQ 0.01% BASE
EQ 0.1% BASE
EQ 0.1% BASE
13.90%
0.10%
0.20%
5%;1%
5%
5%
2.50%
3.75%
2%,4%
2%,4%
2%,4%
0.625MG/GM
15%
2%
EQ 2% BASE
EQ 2% BASE
EQ 2% BASE
EQ 2% BASE
1%
1%
0.01%
0.01%
0.01%
0.01%
2%
2%
2%
1%
2%
3.7%;2.86%;3.42%
4%
2%
2%
2%
4%
2%
2%
2%
4%
2%
1%
1.5MG/GM
15%
3.7%;2.86%;3.42%
0.625MG/GM
0.80%
0.40%
0.40%
0.80%
Page 00134
Appl_Type
A
A
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
A
N
N
N
N
A
N
N
N
N
N
N
N
N
A
N
N
N
N
A
N
N
A
N
A
A
N
A
A
A
N
N
N
N
N
A
A
A
A
A
A
A
A
A
N
N
N
A
A
N
N
N
N
A
N
90098
1
202209
1
21112
1
84908
1
84908
2
84908
3
87113
1
87798
1
87797
1
87932
1
85692
1 AT
85692
3 AT
85692
2 AT
89797
1
89798
1
88094
1
88095
1
88096
1
86415
1 AT
86414
1 AT
86413
1 AT
87990
1
87991
1
87992
1
87921
1
87912
1
87922
1
40038
1
86277
1
40039
1 AT
86276
1
86275
1
89274
1
89275
1
89276
1
40671
1 AT
40671
2 AT
87430
1
87429
1
87428
1
88042
1 AT
88196
1
88197
1
88198
1
18682
1
89472
1
19967
1 AB
16998
2
16322
2
16322
1
70050
1 AB
21145
1
21758
1 AB
17950
1
22436
1
20126
1
21478
1
22483
2
22483
1
76357
1
21261
3
21261
1
20216
1
6530
3
200923
1
50680
1
50680
2 AB
65139
1 AB
50793
1
74165
1
72641
1
6110
5
83518
1
86069
1
84436
1
19215
1
20421
1
19881
1
18052
2
20574
1
88607
1
76773
1
74164
1
74366
1
74760
1
91366
1
74444
1
74136
1
74030
1
20827
1
17450
2
18230
2
84710
1
88718
1
5794
1
21788
1
19964
1 AB
19579
1 AB
76712
1 AB
21735
1 BX
Approval_Date
22‐Mar‐10
11‐Oct‐12
18‐Jan‐02
4‐Jun‐82
7‐Jun‐82
9‐May‐83
31‐May‐91
31‐May‐91
1‐Sep‐83
1‐Sep‐83
1‐Sep‐83
7‐Jul‐83
7‐Jul‐83
7‐Jul‐83
10‐Aug‐82
10‐Aug‐82
10‐Aug‐82
26‐Oct‐94
26‐Nov‐97
21‐Feb‐89
21‐Feb‐89
21‐Feb‐89
9‐Jun‐06
9‐Jun‐06
1‐Nov‐88
1‐Nov‐88
1‐Nov‐88
19‐Mar‐84
25‐Mar‐83
25‐Mar‐83
25‐Mar‐83
18‐Feb‐83
13‐Jun‐88
27‐Dec‐90
10‐Oct‐84
27‐Jul‐00
11‐Feb‐05
31‐Jul‐09
1‐Apr‐94
30‐Dec‐02
15‐Jul‐11
25‐Mar‐10
30‐Mar‐04
17‐Jun‐03
2‐Feb‐01
27‐Jan‐87
18‐May‐12
11‐Aug‐92
2‐Mar‐98
27‐Dec‐04
30‐Nov‐04
16‐Jul‐93
4‐Dec‐95
31‐Jan‐84
25‐Nov‐85
21‐Dec‐95
7‐Feb‐97
30‐Nov‐90
24‐Nov‐98
9‐Jun‐86
2‐Mar‐05
29‐Mar‐96
22‐Feb‐96
15‐May‐97
15‐Jan‐10
13‐Jan‐97
4‐Jan‐95
30‐Oct‐92
30‐Mar‐98
15‐Feb‐91
26‐Dec‐91
19‐Sep‐85
28‐Nov‐08
21‐Feb‐91
31‐Dec‐87
18‐Feb‐05
1‐Oct‐04
RLD
Yes
No
Yes
No
No
No
No
No
No
No
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
Yes
Yes
No
Yes
Yes
Yes
Yes
Yes
No
No
Yes
Yes
Yes
Yes
No
Yes
No
Yes
No
No
No
No
Yes
No
No
Yes
No
Yes
Yes
No
No
No
No
No
No
No
No
No
Yes
Yes
No
No
No
No
No
Yes
Yes
No
Yes
Type
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
OTC
OTC
OTC
RX
RX
RX
DISCN
RX
RX
RX
OTC
OTC
DISCN
DISCN
RX
DISCN
DISCN
OTC
DISCN
OTC
OTC
DISCN
OTC
OTC
OTC
OTC
OTC
OTC
DISCN
DISCN
OTC
OTC
OTC
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
Applicant_Full_Name
PHARMAFAIR INC
PHARMAFAIR INC
PHARMAFAIR INC
TOPIDERM INC
TOPIDERM INC
TOPIDERM INC
CROWN LABORATORIES INC
SKINMEDICA INC
L PERRIGO CO
LUMARA HEALTH INC
WARNER CHILCOTT US LLC
ROCHE PALO ALTO LLC
LUMARA HEALTH INC
L PERRIGO CO
PERRIGO R AND D CO
TEVA WOMENS HEALTH INC
NYCOMED US INC
Page 00135
Ingredient
TERCONAZOLE
TERCONAZOLE
CLOTRIMAZOLE
BACITRACIN; POLYMYXIN B SULFATE
NITROFURAZONE
SILVER SULFADIAZINE
BROMPHENIRAMINE MALEATE
BUTABARBITAL SODIUM
BUTABARBITAL SODIUM
BUTABARBITAL SODIUM
BUTABARBITAL SODIUM
DF;Route
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
CREAM;VAGINAL
DISC;INHALATION
DISC;TOPICAL
DISC;TOPICAL
DISC;TOPICAL
DRESSING;TOPICAL
DRESSING;TOPICAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
CARBINOXAMINE MALEATE
DEXAMETHASONE
DEXAMETHASONE
DEXAMETHASONE
DEXAMETHASONE
DEXAMETHASONE
DEXAMETHASONE
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
DIGOXIN
THEOPHYLLINE
DEXAMETHASONE
THEOPHYLLINE
ETHYLESTRENOL
PENTOBARBITAL
DYPHYLLINE
METHYPRYLON
TRIPELENNAMINE CITRATE
BUTABARBITAL SODIUM
RESERPINE
THEOPHYLLINE SODIUM GLYCINATE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
CLEVIDIPINE
CLEVIDIPINE
CLEVIDIPINE
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL
DIFLUPREDNATE
CYCLOSPORINE
SULFISOXAZOLE ACETYL
BENZYL BENZOATE
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
ELIXIR;ORAL
EMULSION;INTRAVENOUS
EMULSION;IV (INFUSION)
EMULSION;OPHTHALMIC
EMULSION;OPHTHALMIC
EMULSION;ORAL
EMULSION;TOPICAL
Page 00136
Trade_Name
TERCONAZOLE
TERCONAZOLE
TRIPLE SULFA
TRIPLE SULFA
TRIPLE SULFA
TRIVAGIZOLE 3
TRYSUL
VAGILIA
NORISODRINE AEROTROL
DIPROSONE
EMLA
LANABIOTIC
ACTIN‐N
SILDAFLO
ARTANE
BELIX
BENADRYL
BUTABARB
BUTABARBITAL SODIUM
BUTALAN
BUTISOL SODIUM
Applicant
TARO
TARO
ALPHARMA US PHARMS
FOUGERA
PERRIGO NEW YORK
TARO
SAVAGE LABS
TEVA
ABBOTT
SCHERING
ASTRAZENECA
COMBE
SHERWOOD MEDCL
FRANKLIN PHARMS
LEDERLE
HALSEY
MCNEIL CONS
ALPHARMA US PHARMS
KV PHARM
PHARM ASSOC
USL PHARMA
ALPHARMA US PHARMS
WOCKHARDT
LANNETT
MEDA PHARMS
CLISTIN
DECADRON
DEXAMETHASONE
DEXAMETHASONE
DEXAMETHASONE
DEXAMETHASONE
DEXAMETHASONE
MCNEIL
MERCK
ALPHARMA US PHARMS
LYNE
STI PHARMA LLC
VINTAGE PHARMS
WOCKHARDT EU OPERATN
DEXEDRINE
DIBENIL
DIGOXIN
DIPHEN
ELIXOMIN
HEXADROL
HYDRAMINE
LANOPHYLLIN
MAXIBOLIN
NEMBUTAL
NEOTHYLLINE
NOLUDAR
PBZ
PROLIXIN
SARISOL
SERPASIL
SYNOPHYLATE
THEOLIXIR
THEOPHYL‐225
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
THEOPHYLLINE
CLEVIPREX
CLEVIPREX
CLEVIPREX
GLAXOSMITHKLINE
CENCI
ROXANE
USL PHARMA
BUNDY
CENCI
KV PHARM
LANNETT
LEDERLE
MK LABS
NASKA
PERRIGO
PHARM ASSOC
PUREPAC PHARM
PVT FORM
ROXANE
CENCI
ANI PHARMS INC
PHARM ASSOC
ORGANON USA INC
ALPHARMA US PHARMS
LANNETT
ORGANON USA INC
OAK PHARMS
TEVA
ROCHE
NOVARTIS
APOTHECON
HALSEY
NOVARTIS
CENT PHARMS
PANRAY
ORTHO MCNEIL PHARM
ALPHARMA US PHARMS
CENCI
HALSEY
PERRIGO
PHARM ASSOC
PRECISION DOSE
ROXANE
TARO
WOCKHARDT
MIKART
PHARM ASSOC
PHARM VENTURES
MEDICINES CO
MEDICINES CO
MEDICINES CO
KABIVEN IN PLASTIC CONTAINER
FRESENIUS KABI USA
FRESENIUS KABI USA
FRESENIUS KABI USA
FRESENIUS KABI USA
PERIKABIVEN IN PLASTIC CONTAINER
FRESENIUS KABI USA
FRESENIUS KABI USA
DUREZOL
RESTASIS
LIPO GANTRISIN
BENZYL BENZOATE
FRESENIUS KABI USA
ALCON PHARMS LTD
ALLERGAN
ROCHE
LANNETT
Strength
0.40%
0.80%
3.7%;2.86%;3.42%
3.7%;2.86%;3.42%
3.7%;2.86%;3.42%
2%
3.7%;2.86%;3.42%
3.7%;2.86%;3.42%
0.25%
EQ 0.1% BASE
2.5%;2.5%
500 UNITS/GM;5,000 UNITS/GM
0.20%
1%
2MG/5ML
12.5MG/5ML
12.5MG/5ML
2MG/5ML
2MG/5ML
2MG/5ML
2MG/5ML
30MG/5ML
30MG/5ML
33.3MG/5ML
30MG/5ML
4MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
0.5MG/5ML
0.5MG/5ML
0.5MG/5ML
0.5MG/5ML
0.5MG/5ML
0.5MG/5ML
5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
12.5MG/5ML
0.05MG/ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
12.5MG/5ML
80MG/15ML
2.5MG/5ML
2.5MG/5ML
0.5MG/5ML
12.5MG/5ML
80MG/15ML
2MG/5ML
18.2MG/5ML
160MG/15ML
50MG/5ML
EQ 25MG HCL/5ML
2.5MG/5ML
30MG/5ML
0.2MG/4ML
EQ 165MG BASE/15ML
80MG/15ML
112.5MG/15ML
80MG/15ML
80MG/15ML
80MG/15ML
80MG/15ML
80MG/15ML
80MG/15ML
80MG/15ML
80MG/15ML
80MG/15ML
2MG/5ML
2MG/5ML
2MG/5ML
25MG/50ML (0.5MG/ML)
50MG/100ML (0.5MG/ML)
125MG/250ML (0.5MG/ML)
3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML ;147MG/100ML;3.9GM/100ML (1026ML)
3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML;174MG/100ML;239MG/100ML;147MG/100ML;3.9
GM/100ML (1540ML)
GM/100ML (2053ML)
GM/100ML (2566ML)
GM/100ML (1440ML)
GM/100ML (1920ML)
2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML;124MG/100ML;170MG/100ML ;105MG/100ML;3.5GM/100ML (2400ML)
0.05%
0.05%
EQ 1GM BASE/5ML
50%
Page 00137
Appl_Type
A
A
A
A
A
N
A
A
N
N
N
N
N
N
N
A
N
A
A
A
A
A
A
A
A
76043
1 AB
75953
1 AB
87864
1
86424
1
87285
1
21143
1
87887
1
88821
1
16814
1
17829
1
20962
1
50598
1
17343
1
19608
1
6773
9
86586
1
5845
4
86936
1
85466
1
87517
1
87964
1
85873
1
85383
1
85880
1
85380
1
Approval_Date
19‐Jan‐05
6‐Apr‐04
1‐Sep‐82
15‐Nov‐82
12‐Apr‐00
23‐Jul‐82
9‐Nov‐87
4‐Feb‐98
22‐Sep‐86
30‐Nov‐89
3‐Oct‐83
25‐Jan‐83
RLD
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Type
RX
RX
DISCN
DISCN
DISCN
OTC
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
Applicant_Full_Name
ASTRAZENECA LP
COMBE INC
SHERWOOD MEDICAL CO
FRANKLIN PHARMACEUTICALS INC
HALSEY DRUG CO INC
USL PHARMA INC
LANNETT CO INC
No
No
No
No
Yes
No
No
DISCN
DISCN
DISCN
RX
RX
RX
RX
MCNEIL PHARMACEUTICAL CO DIV MCNEILAB INC
MERCK AND CO INC
STI PHARMA LLC
WOCKHARDT EU OPERATIONS SWISS AG
No
No
Yes
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
Yes
Yes
Yes
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
RX
RX
RX
GLAXOSMITHKLINE
USL PHARMA INC
CM BUNDY CO
LANNETT CO INC
MK LABORATORIES INC
NASKA PHARMACAL CO INC DIV RUGBY DARBY GROUP COSMETICS
L PERRIGO CO
ORGANON USA INC
LANNETT CO INC
ORGANON USA INC
HALSEY DRUG CO INC
CENCI POWDER PRODUCTS INC
HALSEY DRUG CO INC
L PERRIGO CO
PRECISION DOSE INC
MIKART INC
PHARMACEUTICAL VENTURES LTD
THE MEDICINES CO
THE MEDICINES CO
THE MEDICINES CO
N
N
A
A
A
A
A
8955
12376
88997
90891
84754
91188
88254
1
2
1
1
1
1
1
AA
AA
AA
AA
10‐Oct‐86
12‐Jul‐11
11‐May‐11
27‐Jul‐83
A
A
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
A
A
N
A
N
N
N
N
A
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
83902
88304
21648
84640
83674
87941
85621
80939
86937
83088
88680
83063
87513
83237
85287
80643
88303
81310
40146
12674
80763
84578
14006
83244
7794
9660
5914
12145
84723
9115
6333
84559
86485
89223
87679
85169
85952
86720
85863
84739
89626
86748
40251
40177
89514
22156
22156
22156
1
1
1
1
1
1
1
2
1
2
1
1
1
1
1
1
1
1
1
1
2
1
2
1
3
7
4
3
1
5
8
1
1
1
1
1
1
1
1
1
1
1
1 AA
1 AA
1
1
2
3
16‐Dec‐83
26‐Aug‐04
17‐Dec‐82
31‐May‐85
10‐Feb‐82
25‐Jan‐82
25‐Jan‐84
29‐Apr‐93
21‐Aug‐96
27‐May‐88
15‐Apr‐82
28‐Oct‐88
27‐Sep‐99
17‐Apr‐97
7‐Apr‐89
1‐Aug‐08
1‐Aug‐08
8‐Nov‐13
N
200656
4
25‐Aug‐14 No
RX
N
200656
5
25‐Aug‐14 No
RX
N
200656
6
25‐Aug‐14 No
RX
N
200656
7
25‐Aug‐14 Yes RX
N
200656
1
25‐Aug‐14 No
RX
N
200656
2
25‐Aug‐14 No
RX
N
N
N
N
A
200656
22212
50790
9182
84535
3
1
1
9
1
RX
RX
RX
DISCN
DISCN
ALCON PHARMACEUTICALS LTD
ALLERGAN INC
LANNETT CO INC
25‐Aug‐14
23‐Jun‐08
23‐Dec‐02
No
Yes
Yes
No
No
Page 00138
Ingredient
ESTRADIOL HEMIHYDRATE
HEXACHLOROPHENE
HEXACHLOROPHENE
HEXACHLOROPHENE
HEXACHLOROPHENE
HEXACHLOROPHENE
HYDROCORTISONE
HYDROCORTISONE
HYDROCORTISONE
METHYLPREDNISOLONE ACETATE
MESALAMINE
MESALAMINE
MESALAMINE
MESALAMINE
AMINOPHYLLINE
LIDOCAINE
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
TESTOSTERONE
TESTOSTERONE
TESTOSTERONE
TESTOSTERONE
BUPRENORPHINE
BUPRENORPHINE
BUPRENORPHINE
BUPRENORPHINE
BUPRENORPHINE
CLONIDINE
CLONIDINE
CLONIDINE
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL; LEVONORGESTREL
CLONIDINE
CLONIDINE
CLONIDINE
CLONIDINE
CLONIDINE
CLONIDINE
CLONIDINE
CLONIDINE
CLONIDINE
CLONIDINE
CLONIDINE
CLONIDINE
ESTRADIOL; NORETHINDRONE ACETATE
ESTRADIOL; NORETHINDRONE ACETATE
METHYLPHENIDATE
METHYLPHENIDATE
METHYLPHENIDATE
METHYLPHENIDATE
FENTANYL
FENTANYL
FENTANYL
FENTANYL
FENTANYL
SELEGILINE
SELEGILINE
SELEGILINE
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
RIVASTIGMINE
RIVASTIGMINE
RIVASTIGMINE
ESTRADIOL
FENTANYL
FENTANYL
FENTANYL
FENTANYL
FENTANYL
FENTANYL
FENTANYL
FENTANYL
FENTANYL
FENTANYL
FENTANYL
FENTANYL
FENTANYL
FENTANYL
DF;Route
EMULSION;TOPICAL
EMULSION;TOPICAL
EMULSION;TOPICAL
EMULSION;TOPICAL
EMULSION;TOPICAL
EMULSION;TOPICAL
ENEMA;RECTAL
ENEMA;RECTAL
ENEMA;RECTAL
ENEMA;RECTAL
ENEMA;RECTAL
ENEMA;RECTAL
ENEMA;RECTAL
ENEMA;RECTAL
ENEMA;RECTAL
FIBER, EXTENDED RELEASE;PERIODONTAL
FILM, EXTENDED RELEASE;BUCCAL
FILM, EXTENDED RELEASE;TRANSDERMAL
Page 00139
Trade_Name
ESTRASORB
HEXA‐GERM
PHISOHEX
PHISOHEX
SOY‐DOME
TURGEX
COLOCORT
CORTENEMA
HYDROCORTISONE
MEDROL
MESALAMINE
MESALAMINE
ROWASA
SFROWASA
SOMOPHYLLIN
ACTISITE
DENTIPATCH
ALORA
ALORA
ALORA
ALORA
ANDRODERM
ANDRODERM
ANDRODERM
ANDRODERM
BUTRANS
BUTRANS
BUTRANS
BUTRANS
BUTRANS
CATAPRES‐TTS‐1
CATAPRES‐TTS‐2
CATAPRES‐TTS‐3
CLIMARA
CLIMARA
CLIMARA
CLIMARA
CLIMARA
CLIMARA
CLIMARA PRO
CLONIDINE
CLONIDINE
CLONIDINE
CLONIDINE
CLONIDINE
CLONIDINE
CLONIDINE
CLONIDINE
CLONIDINE
CLONIDINE
CLONIDINE
CLONIDINE
COMBIPATCH
COMBIPATCH
DAYTRANA
DAYTRANA
DAYTRANA
DAYTRANA
DURAGESIC‐100
DURAGESIC‐12
DURAGESIC‐25
DURAGESIC‐50
DURAGESIC‐75
EMSAM
EMSAM
EMSAM
ESCLIM
ESCLIM
ESCLIM
ESCLIM
ESCLIM
ESTRADERM
ESTRADERM
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
EXELON
EXELON
EXELON
FEMPATCH
FENTANYL‐100
FENTANYL‐100
FENTANYL‐100
FENTANYL‐100
FENTANYL‐100
FENTANYL‐100
FENTANYL‐100
FENTANYL‐12
FENTANYL‐25
FENTANYL‐25
FENTANYL‐25
FENTANYL‐25
FENTANYL‐25
FENTANYL‐25
Applicant
MEDICIS
HUNTINGTON LABS
SANOFI AVENTIS US
SANOFI AVENTIS US
BAYER PHARMS
XTTRIUM
PADDOCK LLC
ANI PHARMS
TEVA PHARMS
PERRIGO ISRAEL
TEVA
MEDA PHARMS
MEDA PHARMS
FISONS
SCHIFF AND CO
NOVEN
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
PURDUE PHARMA LP
PURDUE PHARMA LP
PURDUE PHARMA LP
PURDUE PHARMA LP
PURDUE PHARMA LP
BAYER HLTHCARE
BAYER HLTHCARE
BAYER HLTHCARE
BAYER HLTHCARE
BAYER HLTHCARE
BAYER HLTHCARE
BAYER HLTHCARE
AVEVA
AVEVA
AVEVA
BARR
BARR
BARR
MYLAN TECHNOLOGIES
MYLAN TECHNOLOGIES
MYLAN TECHNOLOGIES
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
NOVARTIS
NOVARTIS
NOVEN PHARMS INC
NOVEN PHARMS INC
NOVEN PHARMS INC
NOVEN PHARMS INC
JANSSEN PHARMS
JANSSEN PHARMS
JANSSEN PHARMS
JANSSEN PHARMS
JANSSEN PHARMS
SOMERSET
SOMERSET
SOMERSET
WOMEN FIRST HLTHCARE
NOVARTIS
NOVARTIS
MYLAN TECHNOLOGIES
MYLAN TECHNOLOGIES
MYLAN TECHNOLOGIES
MYLAN TECHNOLOGIES
MYLAN TECHNOLOGIES
MYLAN TECHNOLOGIES
ORTHO MCNEIL PHARM
ORTHO MCNEIL PHARM
ORTHO MCNEIL PHARM
NOVARTIS
NOVARTIS
NOVARTIS
PARKE DAVIS
AVEVA
LAVIPHARM LABS
MALLINCKRODT INC
MYLAN TECHNOLOGIES
NOVEN
PAR PHARM INC
WATSON LABS
MYLAN TECHNOLOGIES
AVEVA
LAVIPHARM LABS
MALLINCKRODT INC
MYLAN TECHNOLOGIES
NOVEN
PAR PHARM INC
Strength
0.25%
3%
3%
3%
3%
3%
100MG/60ML
100MG/60ML
100MG/60ML
40MG/BOT
4GM/60ML
4GM/60ML
4GM/60ML
4GM/60ML
300MG/5ML
12.7MG/FIBER
23MG/PATCH
0.025MG/24HR
0.05MG/24HR
0.075MG/24HR
0.1MG/24HR
2MG/24HR
2.5MG/24HR
4MG/24HR
5MG/24HR
5MCG/HR
7.5MCG/HR
10MCG/HR
15MCG/HR
20MCG/HR
0.1MG/24HR
0.2MG/24HR
0.3MG/24HR
0.025MG/24HR
0.0375MG/24HR
0.05MG/24HR
0.06MG/24HR
0.075MG/24HR
0.1MG/24HR
0.045MG/24HR;0.015MG/24HR
0.1MG/24HR
0.2MG/24HR
0.3MG/24HR
0.1MG/24HR
0.2MG/24HR
0.3MG/24HR
0.1MG/24HR
0.2MG/24HR
0.3MG/24HR
0.1MG/24HR
0.2MG/24HR
0.3MG/24HR
0.05MG/24HR;0.14MG/24HR
0.05MG/24HR;0.25MG/24HR
10MG/9HR (1.1MG/HR)
15MG/9HR (1.6MG/HR)
20MG/9HR (2.2MG/HR)
30MG/9HR (3.3MG/HR)
100MCG/HR
12.5MCG/HR
25MCG/HR
50MCG/HR
75MCG/HR
6MG/24HR
9MG/24HR
12MG/24HR
0.025MG/24HR
0.0375MG/24HR
0.05MG/24HR
0.075MG/24HR
0.1MG/24HR
0.05MG/24HR
0.1MG/24HR
0.025MG/24HR
0.0375MG/24HR
0.05MG/24HR
0.06MG/24HR
0.075MG/24HR
0.1MG/24HR
0.05MG/24HR
0.075MG/24HR
0.1MG/24HR
4.6MG/24HR
9.5MG/24HR
13.3MG/24HR
0.025MG/24HR
100MCG/HR
100MCG/HR
100MCG/HR
100MCG/HR
100MCG/HR
100MCG/HR
100MCG/HR
12.5MCG/HR
25MCG/HR
25MCG/HR
25MCG/HR
25MCG/HR
25MCG/HR
25MCG/HR
Page 00140
Appl_Type
N
N
N
N
N
N
A
N
A
N
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
A
A
A
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
21371
1
17411
1
6882
1
8402
1
17405
1
19055
1
75172
1 AB
16199
1 AB
74171
1 AB
18102
1
76751
1 AB
76841
1 AB
19618
1 AB
19618
2 AB
18232
1
50653
1
20575
1
20655
4 BX
20655
1 BX
20655
2 BX
20655
3 BX
20489
3
20489
1
20489
4
20489
2
21306
1
21306
5
21306
2
21306
4
21306
3
18891
1 AB
18891
2 AB
18891
3 AB
20375
4 AB2
20375
5 AB
20375
1 AB2
20375
6 AB
20375
3 AB2
20375
2 AB2
21258
1
76157
1 AB
76157
2 AB
76157
3 AB
79090
1 AB
79090
2 AB
79090
3 AB
76166
1 AB
76166
2 AB
76166
3 AB
90873
1 AB
90873
2 AB
90873
3 AB
20870
1
20870
2
21514
1
21514
2
21514
3
21514
4
19813
1 AB
19813
5 AB
19813
4 AB
19813
3 AB
19813
2 AB
21336
1
21336
2
21336
3
20847
1
20847
2
20847
3
20847
4
20847
5
19081
2 BX
19081
3 BX
75182
3 AB2
75182
4 AB
75182
6 AB2
75182
5 AB
75182
2 AB2
75182
1 AB2
21048
1
21048
2
21048
3
22083
1
22083
2
22083
5
20417
1
77449
4 AB
77051
4 AB
77154
4 AB
76258
4 AB
77775
4
77062
4 AB
76709
4 AB
76258
5 AB
77449
1 AB
77051
1 AB
77154
1 AB
76258
1 AB
77775
1
77062
1 AB
Approval_Date
9‐Oct‐03
30‐Nov‐84
3‐Dec‐99
27‐May‐94
17‐Sep‐04
30‐Sep‐04
24‐Dec‐87
20‐Jun‐08
2‐Apr‐82
25‐Mar‐94
21‐May‐96
5‐Apr‐02
20‐Dec‐96
20‐Dec‐96
20‐Dec‐96
20‐Oct‐11
29‐Sep‐95
20‐Oct‐11
2‐May‐97
30‐Jun‐10
30‐Jun‐14
30‐Jun‐10
25‐Jul‐13
30‐Jun‐10
10‐Oct‐84
10‐Oct‐84
10‐Oct‐84
5‐Mar‐99
27‐May‐03
22‐Dec‐94
27‐May‐03
23‐Mar‐98
22‐Dec‐94
21‐Nov‐03
18‐Aug‐09
18‐Aug‐09
18‐Aug‐09
20‐Aug‐10
20‐Aug‐10
20‐Aug‐10
16‐Jul‐10
16‐Jul‐10
16‐Jul‐10
6‐May‐14
6‐May‐14
6‐May‐14
7‐Aug‐98
7‐Aug‐98
6‐Apr‐06
6‐Apr‐06
6‐Apr‐06
6‐Apr‐06
7‐Aug‐90
4‐Feb‐05
7‐Aug‐90
7‐Aug‐90
7‐Aug‐90
27‐Feb‐06
27‐Feb‐06
27‐Feb‐06
4‐Aug‐98
4‐Aug‐98
4‐Aug‐98
4‐Aug‐98
4‐Aug‐98
10‐Sep‐86
10‐Sep‐86
26‐Jan‐05
20‐Jul‐06
24‐Feb‐00
20‐Jul‐06
26‐Jan‐05
24‐Feb‐00
20‐Sep‐99
20‐Sep‐99
20‐Sep‐99
6‐Jul‐07
6‐Jul‐07
31‐Aug‐12
3‐Dec‐96
20‐Oct‐08
4‐Aug‐06
9‐Feb‐11
28‐Jan‐05
16‐Oct‐09
20‐Aug‐07
20‐Aug‐07
23‐Jan‐07
20‐Oct‐08
4‐Aug‐06
9‐Feb‐11
28‐Jan‐05
16‐Oct‐09
20‐Aug‐07
RLD
Yes
No
Yes
No
No
No
No
Yes
No
No
No
No
Yes
No
No
No
No
No
No
No
No
Yes
No
Yes
No
No
No
No
No
Yes
No
No
Yes
No
No
No
No
No
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
Yes
No
No
Yes
No
No
Yes
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Type
RX
DISCN
RX
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
Applicant_Full_Name
HUNTINGTON LABORATORIES INC
FISONS CORP
SCHIFF AND CO
NOVEN PHARMACEUTICALS INC
PURDUE PHARMA LP
PURDUE PHARMA LP
PURDUE PHARMA LP
PURDUE PHARMA LP
PURDUE PHARMA LP
AVEVA DRUG DELIVERY SYSTEMS INC
WOMEN FIRST HEALTHCARE INC
LAVIPHARM LABORATORIES INC
MALLINCKRODT INC
MALLINCKRODT INC
Page 00141
Ingredient
FENTANYL
FENTANYL
FENTANYL
FENTANYL
FENTANYL
FENTANYL
FENTANYL
FENTANYL
FENTANYL
FENTANYL
FENTANYL
FENTANYL
FENTANYL
FENTANYL
FENTANYL
NICOTINE
NICOTINE
NICOTINE
ESTRADIOL
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ROTIGOTINE
ROTIGOTINE
ROTIGOTINE
ROTIGOTINE
ROTIGOTINE
ROTIGOTINE
NICOTINE
NICOTINE
NICOTINE
NICOTINE
NICOTINE
NICOTINE
NICOTINE
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
ETHINYL ESTRADIOL; NORELGESTROMIN
OXYBUTYNIN
OXYBUTYNIN
OXYBUTYNIN
NICOTINE
NICOTINE
GRANISETRON
TESTOSTERONE
TESTOSTERONE
TESTOSTERONE
SCOPOLAMINE
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ESTRADIOL
ETHINYL ESTRADIOL; NORELGESTROMIN
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
FENTANYL CITRATE
FENTANYL CITRATE
FENTANYL CITRATE
FENTANYL CITRATE
FENTANYL CITRATE
KETOPROFEN
ONDANSETRON
ONDANSETRON
DF;Route
FILM;BUCCAL
FILM;BUCCAL
FILM;BUCCAL
FILM;BUCCAL
FILM;BUCCAL
FILM;BUCCAL
FILM;BUCCAL
FILM;BUCCAL
FILM;ORAL
FILM;ORAL
FILM;ORAL
FILM;SUBLINGUAL
FILM;SUBLINGUAL
FILM;SUBLINGUAL
Page 00142
Trade_Name
FENTANYL‐25
FENTANYL‐50
FENTANYL‐50
FENTANYL‐50
FENTANYL‐50
FENTANYL‐50
FENTANYL‐50
FENTANYL‐50
FENTANYL‐75
FENTANYL‐75
FENTANYL‐75
FENTANYL‐75
FENTANYL‐75
FENTANYL‐75
FENTANYL‐75
HABITROL
HABITROL
HABITROL
MENOSTAR
MINITRAN
MINITRAN
MINITRAN
MINITRAN
MINIVELLE
MINIVELLE
MINIVELLE
MINIVELLE
NEUPRO
NEUPRO
NEUPRO
NEUPRO
NEUPRO
NEUPRO
NICODERM CQ
NICODERM CQ
NICODERM CQ
NICOTINE
NICOTINE
NICOTINE
NICOTROL
NITRO‐DUR
NITRO‐DUR
NITRO‐DUR
NITRO‐DUR
NITRO‐DUR
NITRO‐DUR
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
NITROGLYCERIN
ORTHO EVRA
OXYBUTYNIN
OXYTROL
OXYTROL FOR WOMEN
PROSTEP
PROSTEP
SANCUSO
TESTODERM
TESTODERM
TESTODERM TTS
TRANSDERM SCOP
TRANSDERM‐NITRO
TRANSDERM‐NITRO
TRANSDERM‐NITRO
TRANSDERM‐NITRO
TRANSDERM‐NITRO
VIVELLE
VIVELLE
VIVELLE
VIVELLE
VIVELLE
VIVELLE‐DOT
VIVELLE‐DOT
VIVELLE‐DOT
VIVELLE‐DOT
VIVELLE‐DOT
XULANE
BUNAVAIL
BUNAVAIL
BUNAVAIL
ONSOLIS
ONSOLIS
ONSOLIS
ONSOLIS
ONSOLIS
NEXCEDE
ZUPLENZ
ZUPLENZ
SUBOXONE
SUBOXONE
SUBOXONE
Applicant
WATSON LABS
AVEVA
LAVIPHARM LABS
MALLINCKRODT INC
MYLAN TECHNOLOGIES
NOVEN
PAR PHARM INC
WATSON LABS
AVEVA
LAVIPHARM LABS
MALLINCKRODT INC
MYLAN TECHNOLOGIES
NOVEN
PAR PHARM INC
WATSON LABS
NOVARTIS
NOVARTIS
NOVARTIS
BAYER HLTHCARE
MEDICIS
MEDICIS
VALEANT PHARM NORTH
VALEANT PHARM NORTH
NOVEN
NOVEN
NOVEN
NOVEN
UCB INC
UCB INC
UCB INC
UCB INC
UCB INC
UCB INC
SANOFI AVENTIS US
SANOFI AVENTIS US
SANOFI AVENTIS US
AVEVA
AVEVA
AVEVA
MCNEIL CONS
MERCK SHARP DOHME
MERCK SHARP DOHME
MERCK SHARP DOHME
MERCK SHARP DOHME
MERCK SHARP DOHME
MERCK SHARP DOHME
HERCON PHARM
HERCON PHARM
HERCON PHARM
MYLAN TECHNOLOGIES
MYLAN TECHNOLOGIES
MYLAN TECHNOLOGIES
MYLAN TECHNOLOGIES
MYLAN TECHNOLOGIES
MYLAN TECHNOLOGIES
MYLAN TECHNOLOGIES
MYLAN TECHNOLOGIES
JANSSEN PHARMS
BARR LABS DIV TEVA
WATSON LABS (UTAH)
AVEVA
AVEVA
PROSTRAKAN INC
ALZA
ALZA
ALZA
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS
NOVARTIS
MYLAN TECHNOLOGIES
BIODELIVERY SCI INTL
MEDA PHARMS
MEDA PHARMS
MEDA PHARMS
MEDA PHARMS
MEDA PHARMS
NOVARTIS
GALENA BIOPHARMA INC
RECKITT BENCKISER
RECKITT BENCKISER
RECKITT BENCKISER
Strength
25MCG/HR
50MCG/HR
50MCG/HR
50MCG/HR
50MCG/HR
50MCG/HR
50MCG/HR
50MCG/HR
75MCG/HR
75MCG/HR
75MCG/HR
75MCG/HR
75MCG/HR
75MCG/HR
75MCG/HR
7MG/24HR
14MG/24HR
21MG/24HR
0.014MG/24HR
0.2MG/HR
0.4MG/HR
0.1MG/HR
0.6MG/HR
0.0375MG/24HR
0.05MG/24HR
0.075MG/24HR
0.1MG/24HR
1MG/24HR
2MG/24HR
3MG/24HR
4MG/24HR
6MG/24HR
8MG/24HR
7MG/24HR
14MG/24HR
21MG/24HR
7MG/24HR
14MG/24HR
21MG/24HR
15MG/16HR
0.1MG/HR
0.2MG/HR
0.3MG/HR
0.4MG/HR
0.6MG/HR
0.8MG/HR
0.2MG/HR
0.4MG/HR
0.6MG/HR
0.2MG/HR
0.4MG/HR
0.1MG/HR
0.1MG/HR
0.2MG/HR
0.2MG/HR
0.4MG/HR
0.4MG/HR
0.6MG/HR
0.6MG/HR
0.035MG/24HR;0.15MG/24HR
3.9MG/24HR
3.9MG/24HR
3.9MG/24HR
11MG/24HR
22MG/24HR
3.1MG/24HR
4MG/24HR
6MG/24HR
5MG/24HR
1MG/72HR
0.1MG/HR
0.2MG/HR
0.4MG/HR
0.6MG/HR
0.8MG/HR
0.025MG/24HR
0.0375MG/24HR
0.05MG/24HR
0.075MG/24HR
0.1MG/24HR
0.025MG/24HR
0.0375MG/24HR
0.05MG/24HR
0.075MG/24HR
0.1MG/24HR
0.035MG/24HR;0.15MG/24HR
EQ 6.3MG BASE;EQ 1MG BASE
EQ 0.2MG BASE
EQ 0.4MG BASE
EQ 0.6MG BASE
EQ 0.8MG BASE
EQ 1.2MG BASE
12.5MG
4MG
8MG
EQ 2MG BASE;EQ 0.5MG BASE
Page 00143
Appl_Type
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
A
A
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
N
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
76709
1 AB
77449
2 AB
77051
2 AB
77154
2 AB
76258
2 AB
77775
2
77062
2 AB
76709
2 AB
77449
3 AB
77051
3 AB
77154
3 AB
76258
3 AB
77775
3
77062
3 AB
76709
3 AB
20076
4
20076
5
20076
6
21674
1
89772
1 AB1
89773
1 AB1
89771
1 AB1
89774
1 AB1
203752
1
203752
3
203752
2
203752
4
21829
4
21829
1
21829
5
21829
2
21829
3
21829
6
20165
6
20165
5
20165
4
74612
2
74612
3
74612
1
20536
1
20145
1 AB1
20145
2 AB1
20145
3
20145
4 AB1
20145
5 AB1
20145
6
89884
1 AB2
89885
1 AB2
89886
1 AB2
75115
1
75115
2
74559
4
74992
4
74559
3 AB2
74992
3
74559
2 AB2
74992
2
74559
1 AB2
74992
1
21180
1 AB
90526
1 AB
21351
2 AB
202211
1
19983
3
19983
4
22198
1
19762
1
19762
2
20791
1
17874
1
20144
1
20144
2
20144
3
20144
4
20144
5
20323
5
20323
1
20323
2 AB1
20323
3
20323
4 AB1
20538
9 BX
20538
5 BX
20538
6 AB1
20538
7 BX
20538
8 AB1
200910
1 AB
205637
1
205637
2
205637
3
22266
1
22266
2
22266
3
22266
4
22266
5
22470
1
22524
1
22524
2
22410
1
22410
3
22410
2
Approval_Date
20‐Aug‐07
20‐Oct‐08
4‐Aug‐06
9‐Feb‐11
28‐Jan‐05
16‐Oct‐09
20‐Aug‐07
20‐Aug‐07
20‐Oct‐08
4‐Aug‐06
9‐Feb‐11
28‐Jan‐05
16‐Oct‐09
20‐Aug‐07
20‐Aug‐07
12‐Nov‐99
12‐Nov‐99
12‐Nov‐99
8‐Jun‐04
30‐Aug‐96
30‐Aug‐96
30‐Aug‐96
30‐Aug‐96
29‐Oct‐12
29‐Oct‐12
29‐Oct‐12
29‐Oct‐12
2‐Apr‐12
9‐May‐07
2‐Apr‐12
9‐May‐07
9‐May‐07
2‐Apr‐12
2‐Aug‐96
2‐Aug‐96
2‐Aug‐96
28‐Jul‐03
20‐Oct‐97
20‐Oct‐97
3‐Jul‐96
4‐Apr‐95
4‐Apr‐95
4‐Apr‐95
4‐Apr‐95
4‐Apr‐95
4‐Apr‐95
30‐Oct‐98
30‐Oct‐98
30‐Oct‐98
10‐Aug‐04
10‐Aug‐04
6‐Feb‐98
12‐Nov‐99
30‐Aug‐96
12‐Nov‐99
30‐Aug‐96
12‐Nov‐99
30‐Aug‐96
12‐Nov‐99
20‐Nov‐01
4‐Mar‐14
26‐Feb‐03
25‐Jan‐13
23‐Dec‐98
23‐Dec‐98
12‐Sep‐08
12‐Oct‐93
12‐Oct‐93
18‐Dec‐97
27‐Feb‐96
27‐Feb‐96
27‐Feb‐96
27‐Feb‐96
27‐Feb‐96
16‐Aug‐00
28‐Oct‐94
28‐Oct‐94
28‐Oct‐94
28‐Oct‐94
3‐May‐02
8‐Jan‐99
8‐Jan‐99
8‐Jan‐99
8‐Jan‐99
16‐Apr‐14
6‐Jun‐14
6‐Jun‐14
6‐Jun‐14
16‐Jul‐09
16‐Jul‐09
16‐Jul‐09
16‐Jul‐09
16‐Jul‐09
25‐Nov‐09
2‐Jul‐10
2‐Jul‐10
30‐Aug‐10
10‐Aug‐12
30‐Aug‐10
RLD
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
Yes
No
Yes
No
No
No
No
Yes
Yes
Yes
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
Yes
No
No
Yes
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
Yes
No
No
No
No
No
Yes
No
Yes
No
No
No
Type
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
OTC
OTC
OTC
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
OTC
OTC
OTC
OTC
OTC
OTC
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
DISCN
RX
DISCN
RX
DISCN
RX
DISCN
RX
RX
RX
OTC
DISCN
DISCN
RX
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
OTC
RX
RX
RX
RX
RX
Applicant_Full_Name
MALLINCKRODT INC
MALLINCKRODT INC
UCB INC
UCB INC
UCB INC
UCB INC
UCB INC
UCB INC
HERCON PHARMACEUTICAL LLC
BARR LABORATORIES INC SUB TEVA PHARMACEUTICALS USA
PROSTRAKAN INC
ALZA CORP
ALZA CORP
ALZA CORP
MYLAN TECHNOLOGIES
BIODELIVERY SCIENCES INTERNATIONAL INC
RECKITT BENCKISER PHARMACEUTICALS INC
Page 00144
Ingredient
BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
CITRIC ACID; UREA C‐13
AZTREONAM
PENTAMIDINE ISETHIONATE
PENTAMIDINE ISETHIONATE
METHACHOLINE CHLORIDE
RIBAVIRIN
SECRETIN SYNTHETIC HUMAN
SECRETIN SYNTHETIC HUMAN
NESIRITIDE RECOMBINANT
SECRETIN SYNTHETIC PORCINE
HEXAMINOLEVULINATE HYDROCHLORIDE
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'‐PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E
CHYMOTRYPSIN
CHYMOTRYPSIN
CHYMOTRYPSIN
CHLORAMPHENICOL
ACETYLCHOLINE CHLORIDE
ACETYLCHOLINE CHLORIDE
ECHOTHIOPHATE IODIDE
CHYMOTRYPSIN
OXACILLIN SODIUM
PENICILLIN V POTASSIUM
UREA C‐13
DICLOFENAC POTASSIUM
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE
CLINDAMYCIN PALMITATE HYDROCHLORIDE
CLOXACILLIN SODIUM
CLOXACILLIN SODIUM
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS
BETAINE HYDROCHLORIDE
DIDANOSINE
ENALAPRIL MALEATE
FERRIC AMMONIUM CITRATE
POLYETHYLENE GLYCOL 3350
UREA C‐13
LACTULOSE
LACTULOSE
DF;Route
FILM;SUBLINGUAL
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
LEUCOVORIN CALCIUM
MANGANESE CHLORIDE TETRAHYDRATE
UREA C‐13
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
GLUTAMINE
OXACILLIN SODIUM
OXACILLIN SODIUM
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL
FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL
FOR SOLUTION, TABLET, FOR SOLUTION;ORAL
FOR SOLUTION;INHALATION
FOR SOLUTION;INTRAVENOUS
FOR SOLUTION;INTRAVESICAL
FOR SOLUTION;IV (INFUSION)
FOR SOLUTION;OPHTHALMIC
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
Page 00145
Trade_Name
SUBOXONE
Applicant
RECKITT BENCKISER
Strength
HALFLYTELY
BRAINTREE
5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM
PEG‐3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE, AND BISACODYL
IDKIT:HP
CAYSTON
NEBUPENT
NEBUPENT
PROVOCHOLINE
VIRAZOLE
CHIRHOSTIM
CHIRHOSTIM
NATRECOR
SECREFLO
CYSVIEW KIT
NOVEL LABS INC
EXALENZ BIOSCIENCE
GILEAD
FRESENIUS KABI USA
FRESENIUS KABI USA
METHAPHARM
VALEANT PHARM INTL
CHIRHOCLIN
CHIRHOCLIN
SCIOS LLC
CHIRHOCLIN
PHOTOCURE ASA
5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM;N/A,5.6GM
N/A,4GM;75MG,N/A
75MG/VIAL
300MG/VIAL
600MG/VIAL
100MG/VIAL
6GM/VIAL
16MCG/VIAL
40MCG/VIAL
1.5MG/VIAL
16MCG/VIAL
100MG/VIAL
M.V.I. PEDIATRIC
ALPHA CHYMAR
CATARASE
CATARASE
CHLOROMYCETIN
MIOCHOL
MIOCHOL‐E
PHOSPHOLINE IODIDE
PHOSPHOLINE IODIDE
PHOSPHOLINE IODIDE
PHOSPHOLINE IODIDE
ZOLYSE
BACTOCILL
BEEPEN‐VK
BEEPEN‐VK
BETAPEN‐VK
BETAPEN‐VK
BREATHTEK UBT FOR H‐PYLORI
CAMBIA
HOSPIRA
SOLA BARNES HIND
CIBA
NOVARTIS
PARKEDALE
NOVARTIS
BAUSCH AND LOMB
WYETH PHARMS INC
WYETH PHARMS INC
WYETH PHARMS INC
WYETH PHARMS INC
ALCON
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
APOTHECON
APOTHECON
OTSUKA AMERICA
DEPOMED INC
80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/
VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL
750 UNITS/VIAL
300 UNITS/VIAL
150 UNITS/VIAL
25MG/VIAL
20MG/VIAL
20MG/VIAL
0.03%
0.06%
0.13%
0.25%
750 UNITS/VIAL
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 75MG /POUCH
50MG
CLENZ‐LYTE
CLEOCIN
CLEOCIN
CLOXACILLIN SODIUM
CLOXACILLIN SODIUM
PADDOCK LLC
AMNEAL PHARMS
LYNE
PADDOCK LABS
TEVA
TEVA
236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT
EQ 75MG BASE/5ML
EQ 75MG BASE/5ML
EQ 75MG BASE/5ML
EQ 75MG BASE/5ML
EQ 75MG BASE/5ML
EQ 75MG BASE/5ML
EQ 125MG BASE/5ML
EQ 125MG BASE/5ML
COLYTE
MEDA PHARMS
120GM/PACKET;1.49GM/PACKET;3.36GM/PACKET;2.92GM/PACKET;11.36GM/PACKET
COLYTE
MEDA PHARMS
227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET
COLYTE
MEDA PHARMS
227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT
COLYTE
MEDA PHARMS
COLYTE
MEDA PHARMS
360GM/PACKET;4.47GM/PACKET;10.08GM/PACKET;8.76GM/PACKET;34.08GM/PACKET
COLYTE WITH FLAVOR PACKS
MEDA PHARMS
COLYTE‐FLAVORED
MEDA PHARMS
227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53GM/BOT;21.5GM/BOT
COLYTE‐FLAVORED
CYSTADANE
DIDANOSINE
EPANED KIT
FERRISELTZ
GLYCOLAX
GLYCOLAX
GLYCOLAX
MEDA PHARMS
RARE DIS THERAP
AUROBINDO PHARMA
SILVERGATE PHARMS
OTSUKA
1GM/SCOOPFUL
10MG/ML
1MG/ML
600MG/PACKET
17GM/SCOOPFUL
17GM/PACKET
17GM/SCOOPFUL
GOLYTELY
BRAINTREE
GOLYTELY
HELICOSOL
LACTULOSE
LACTULOSE
BRAINTREE
METABOLIC SOLUTIONS
CUMBERLAND PHARMS
CUMBERLAND PHARMS
125MG/VIAL
10GM/PACKET
20GM/PACKET
LAX‐LYTE WITH FLAVOR PACKS
LEDERCILLIN VK
LEDERCILLIN VK
LEUCOVORIN CALCIUM
LUMENHANCE
MERETEK UBT KIT (W/ PRANACTIN)
MIRALAX
PADDOCK LLC
LEDERLE
LEDERLE
HOSPIRA
BRACCO
OTSUKA AMERICA
SCHERING PLOUGH
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 60MG BASE/VIAL
3.49MG/GM
125MG/VIAL
17GM/SCOOPFUL
MOVIPREP
NOVEL LABS INC
4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM
MOVIPREP
SALIX PHARMS
4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM
NULYTELY
BRAINTREE
NULYTELY‐FLAVORED
NUTRESTORE
OXACILLIN SODIUM
OXACILLIN SODIUM
BRAINTREE
EMMAUS MEDCL
APOTHECON
TEVA
5GM/PACKET
EQ 250MG BASE/5ML
EQ 250MG BASE/5ML
PEG 3350 AND ELECTROLYTES
MYLAN
236GM;2.97GM;6.74GM;5.86GM;22.74GM
NOVEL LABS INC
Page 00146
Appl_Type
N
22410
4
Approval_Date
RLD Type
10‐Aug‐12 Yes RX
16‐Jul‐10 No
Applicant_Full_Name
N
21551
3
A
N
N
N
N
N
N
N
N
N
N
N
202217
21314
50814
19887
19887
19193
18859
21256
21256
20920
21136
22555
1
1
1
1
2
1
1
1
2
1
1
1
20‐Aug‐14
17‐Dec‐02
22‐Feb‐10
15‐Jun‐89
22‐Mar‐96
31‐Oct‐86
31‐Dec‐85
9‐Apr‐04
21‐Jun‐07
10‐Aug‐01
4‐Apr‐02
28‐May‐10
Yes
Yes
Yes
Yes
No
Yes
Yes
Yes
No
Yes
No
Yes
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
DISCN
RX
EXALENZ BIOSCIENCE LTD
GILEAD SCIENCES INC
METHAPHARM INC
CHIRHOCLIN INC
CHIRHOCLIN INC
SCIOS LLC
CHIRHOCLIN INC
PHOTOCURE ASA
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
A
A
N
N
18920
11837
16938
18121
50143
16211
20213
11963
11963
11963
11963
11903
62321
62270
62270
61149
61149
20586
22165
1
1
1
1
1
1
1
2
4
1
3
1
1
1
2
1
2
2
1
21‐Sep‐00
22‐Sep‐93
10‐May‐01
17‐Jun‐09
Yes
No
No
No
No
No
Yes
No
No
Yes
No
No
No
No
No
No
No
No
Yes
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
HOSPIRA INC
SOLA BARNES HIND
CIBA VISION CORP DIV NOVARTIS CO
BAUSCH AND LOMB INC
ALCON LABORATORIES INC
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
OTSUKA AMERICA PHARMACEUTICALS INC
DEPOMED INC
A
A
A
A
A
A
A
A
A
90769
61827
62644
203513
202409
201821
90902
62268
62978
1
1
1
1
1
1
1
1
1
7‐Jun‐10
7‐Apr‐86
13‐Mar‐14
30‐Apr‐13
28‐Aug‐12
7‐Jul‐10
6‐Apr‐89
No
No
Yes
No
No
No
No
No
No
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
PADDOCK LABORATORIES INC
N
18983
5
26‐Oct‐84 No
N
18983
4
26‐Oct‐84 No
DISCN MEDA PHARMACEUTICALS INC
N
18983
10
31‐Jan‐89 No
RX
AA
AA
AA
AA
AA
DISCN BRAINTREE LABORATORIES INC
N
18983
7
12‐Jun‐87 No
N
18983
6
26‐Oct‐84 No
N
18983
12
8‐Oct‐98 No
RX
N
18983
N
N
A
N
N
A
A
A
18983
20576
78112
204308
20292
76652
90600
90600
8
14‐Nov‐91 No
9
1
1 AA
1
1
1 AA
1
2
14‐Nov‐91
25‐Oct‐96
8‐Mar‐07
13‐Aug‐13
14‐Oct‐97
2‐Jul‐04
6‐Oct‐09
6‐Oct‐09
DISCN
RX
RX
RX
DISCN
RX
OTC
OTC
N
19011
2
N
N
A
A
19011
21092
74712
74712
1 AA
1
1
2
13‐Jul‐84
17‐Dec‐99
10‐Dec‐97
10‐Dec‐97
Yes
No
Yes
Yes
RX
DISCN
RX
RX
BRAINTREE LABORATORIES INC
METABOLIC SOLUTIONS INC
CUMBERLAND PHARMACEUTICALS INC
CUMBERLAND PHARMACEUTICALS INC
A
A
A
N
N
N
N
79232
60136
60136
8107
20686
20586
22015
1 AA
1
2
3
1
1
1
25‐Feb‐10
30‐Jan‐87
19‐Dec‐97
17‐Sep‐96
6‐Oct‐06
No
No
No
No
No
No
Yes
RX
DISCN
DISCN
DISCN
DISCN
DISCN
OTC
HOSPIRA INC
OTSUKA AMERICA PHARMACEUTICALS INC
A
90145
1
N
21881
1
N
19797
1 AA
N
N
A
A
19797
21667
61457
62252
2 AA
1
1
1
No
Yes
No
Yes
No
No
No
No
2‐Jun‐92 Yes RX
25‐Jan‐12 No
RARE DISEASE THERAPEUTICS INC
SILVERGATE PHARMACEUTICALS INC
OTSUKA PHARMACEUTICAL CO LTD
DISCN NOVEL LABORATORIES INC
2‐Aug‐06 Yes RX
22‐Apr‐91 Yes RX
18‐Nov‐94
10‐Jun‐04
Yes
Yes
No
No
RX
RX
DISCN
DISCN
EMMAUS MEDICAL INC
A
90928
1 AA
28‐Jan‐10 No
RX
A
90231
1 AA
1‐Jun‐09 No
RX
Page 00147
Ingredient
DF;Route
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
PENICILLIN G POTASSIUM
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
POTASSIUM CITRATE
FOR SOLUTION;ORAL
POTASSIUM CITRATE
CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
OXACILLIN SODIUM
UREA C‐13
VIGABATRIN
STAVUDINE
STAVUDINE
CLOXACILLIN SODIUM
CLOXACILLIN SODIUM
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
NAFCILLIN SODIUM
VALGANCICLOVIR HYDROCHLORIDE
DIDANOSINE
DIDANOSINE
DIDANOSINE
DIDANOSINE
DIDANOSINE
STAVUDINE
DIATRIZOATE SODIUM
GLATIRAMER ACETATE
MAFENIDE ACETATE
MITOMYCIN
MAFENIDE ACETATE
LANSOPRAZOLE
LANSOPRAZOLE
PANTOPRAZOLE SODIUM
ARIPIPRAZOLE
ARIPIPRAZOLE
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL
FOR SOLUTION;ORAL, RECTAL
FOR SOLUTION;SUBCUTANEOUS
FOR SOLUTION;TOPICAL
FOR SUSPENSION, DELAYED RELEASE;ORAL
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
FOR SOLUTION;ORAL
Page 00148
Trade_Name
Applicant
Strength
NOVEL LABS INC
PEG‐3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE
MYLAN
PEG‐3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE
PEN‐VEE K
PEN‐VEE K
PENAPAR‐VK
PENAPAR‐VK
PENICILLIN
PENICILLIN
PENICILLIN‐2
PENICILLIN‐VK
PENICILLIN‐VK
PENTIDS '200'
PENTIDS '400'
PFIZERPEN G
PFIZERPEN VK
PFIZERPEN VK
NOVEL LABS INC
WYETH AYERST
WYETH AYERST
PARKE DAVIS
PARKE DAVIS
TEVA
TEVA
MYLAN
MYLAN
MYLAN
PUREPAC PHARM
PUREPAC PHARM
AM ANTIBIOTICS
AM ANTIBIOTICS
DAVA PHARMS INC
DAVA PHARMS INC
MYLAN
MYLAN
PUREPAC PHARM
PUREPAC PHARM
TEVA
TEVA
TEVA
APOTHECON
APOTHECON
PFIZER
PFIZER
PFIZER
BRECKENRIDGE PHARM
EMCURE PHARMS USA
MYLAN
MYLAN
NEXGEN PHARMA
NEXGEN PHARMA INC
NOVEL LABS INC
PADDOCK LLC
PADDOCK LLC
PAR PHARM
PERRIGO R AND D
PERRIGO R AND D
TEVA PHARMS
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
200,000 UNITS/5ML
400,000 UNITS/5ML
200,000 UNITS/5ML
250,000 UNITS/5ML
400,000 UNITS/5ML
250,000 UNITS/5ML
400,000 UNITS/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
250,000 UNITS/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
200,000 UNITS/5ML
400,000 UNITS/5ML
400,000 UNITS/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
17GM/SCOOPFUL
17GM/SCOOPFUL
17GM/PACKET
17GM/SCOOPFUL
17GM/SCOOPFUL
17GM/SCOOPFUL
17GM/SCOOPFUL
17GM/SCOOPFUL
17GM/SCOOPFUL
17GM/SCOOPFUL
17GM/PACKET
17GM/SCOOPFUL
17GM/SCOOPFUL
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES
PADDOCK LLC
POTASSIUM CITRATE
UT SW MEDCTR
POTASSIUM CITRATE
PREPOPIK
PROSTAPHLIN
PYLORI‐CHEK BREATH TEST
SABRIL
STAVUDINE
STAVUDINE
TEGOPEN
TEGOPEN
UT SW MEDCTR
FERRING PHARMS AS
APOTHECON
DXS DEVICES
LUNDBECK LLC
AUROBINDO PHARMA
CIPLA LTD
APOTHECON
APOTHECON
10MEQ/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
20MEQ/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
12GM/PACKET;3.5GM/PACKET;10MG/PACKET
EQ 250MG BASE/5ML
100MG/VIAL
500MG/PACKET
1MG/ML
1MG/ML
EQ 125MG BASE/5ML
EQ 125MG BASE/5ML
TRILYTE
UNIPEN
V‐CILLIN K
V‐CILLIN K
VALCYTE
VANCOLED
VANCOLED
VEETIDS
VEETIDS
VEETIDS '125'
VEETIDS '125'
VEETIDS '250'
VEETIDS '250'
VIDEX
VIDEX
VIDEX
VIDEX
VIDEX
ZERIT
HYPAQUE
COPAXONE
MAFENIDE ACETATE
MITOSOL
SULFAMYLON
TOPICYCLINE
NEXIUM
NEXIUM
NEXIUM
NEXIUM
NEXIUM
PREVACID
PREVACID
PRILOSEC
PRILOSEC
PROTONIX
ABILIFY MAINTENA KIT
ABILIFY MAINTENA KIT
MEDA PHARMS
WYETH AYERST
LILLY
LILLY
HOFFMANN LA ROCHE
ANI PHARMS INC
ANI PHARMS INC
LEDERLE
LEDERLE
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
GE HEALTHCARE
TEVA PHARMS USA
PAR FORM
MOBIUS THERAP
MYLAN INSTITUTIONAL
SHIRE
ASTRAZENECA
ASTRAZENECA
ASTRAZENECA
ASTRAZENECA
ASTRAZENECA
TAKEDA PHARMS NA
TAKEDA PHARMS NA
ASTRAZENECA
ASTRAZENECA
WYETH PHARMS INC
OTSUKA PHARM CO LTD
OTSUKA PHARM CO LTD
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
50MG/ML
EQ 250MG BASE/5ML
EQ 500MG BASE/6ML
EQ 250MG BASE/5ML
EQ 500MG BASE/6ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 250MG BASE/5ML
10MG/ML
100MG/PACKET
167MG/PACKET
250MG/PACKET
375MG/PACKET
1MG/ML
100%
20MG/VIAL
5%
0.2MG/VIAL
5%
2.2MG/ML
EQ 2.5MG BASE/PACKET
EQ 5MG BASE/PACKET
EQ 10MG BASE/PACKET
EQ 20MG BASE/PACKET
EQ 40MG BASE/PACKET
15MG/PACKET
30MG/PACKET
EQ 10MG BASE/PACKET
EQ 40MG BASE
300MG/VIAL
400MG/VIAL
Page 00149
Appl_Type
Approval_Date
RLD Type
Applicant_Full_Name
A
90186
1 AA
1‐Jun‐09 No
RX
A
90409
1 AA
2‐Apr‐10 No
RX
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
90019
60007
60007
62002
62002
60307
60307
60752
60752
60752
61740
61740
61529
61529
62981
62981
61624
61624
61758
61758
60307
60456
60456
62149
62149
60587
61815
61815
77736
202071
78915
78915
90812
77706
91077
77893
90567
79214
90685
90685
77445
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
OTC
OTC
OTC
OTC
RX
OTC
RX
DISCN
OTC
OTC
OTC
DISCN
NEXGEN PHARMA INC
NEXGEN PHARMA INC
PERRIGO R AND D CO
PERRIGO R AND D CO
1
1
2
1
2
2
4
3
2
1
1
2
1
2
1
2
2
1
1
2
3
1
2
1
2
1
1
2
1
1
1
2
1
1
1
1
1
1
1
2
1
AA
AA
AA
AA
AA
AA
AA
AA
27‐May‐09
10‐Feb‐89
10‐Feb‐89
26‐May‐06
28‐Dec‐12
6‐Oct‐09
6‐Oct‐09
7‐Oct‐09
27‐Sep‐06
6‐Oct‐09
26‐May‐06
15‐Oct‐09
31‐Jan‐13
6‐Oct‐09
6‐Oct‐09
4‐May‐06
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
A
90712
1
25‐Feb‐10 No
DISCN PADDOCK LABORATORIES LLC
N
19647
2
13‐Oct‐88 No
DISCN UT SOUTHWESTERN MEDCTR
N
N
N
N
N
A
A
A
N
19647
202535
50194
20900
22006
77774
78030
61453
50192
1
1
1
1
1
1 AA
1 AA
1
1
13‐Oct‐88
16‐Jul‐12
4‐Feb‐99
21‐Aug‐09
29‐Dec‐08
20‐Mar‐09
No
Yes
No
No
Yes
No
No
No
No
DISCN
RX
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
UT SOUTHWESTERN MEDCTR
FERRING PHARMACEUTICALS AS
DIAGNOSTICS AND DEVICES INC
LUNDBECK LLC
CIPLA LTD
A
N
A
A
N
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
N
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
76491
50199
60004
60004
22257
61667
61667
63321
63321
61410
61410
61206
62153
61206
62153
20156
20155
20155
20155
20155
20413
11386
20622
201511
22572
19832
50493
21957
21957
22101
21957
21957
21281
21281
22056
22056
22020
202971
202971
1
1
1
2
1
2
1
2
3
1
2
1
1
2
2
1
3
4
5
6
1
1
1
1
1
3
1
3
4
1
1
2
1
2
1
2
1
1
2
5‐Feb‐04
28‐Aug‐09
13‐Jul‐83
15‐Oct‐93
15‐Oct‐93
9‐Oct‐91
9‐Oct‐91
9‐Oct‐91
9‐Oct‐91
9‐Oct‐91
6‐Sep‐96
20‐Dec‐96
12‐Feb‐13
7‐Feb‐12
5‐Jun‐98
15‐Dec‐11
15‐Dec‐11
27‐Feb‐08
20‐Oct‐06
20‐Oct‐06
3‐May‐01
3‐May‐01
20‐Mar‐08
20‐Mar‐08
14‐Nov‐07
28‐Feb‐13
28‐Feb‐13
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
Yes
No
No
No
Yes
Yes
No
No
No
No
No
Yes
No
No
No
Yes
Yes
No
Yes
RX
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
ELI LILLY AND CO
ELI LILLY AND CO
LEDERLE PARENTERALS INC
LEDERLE PARENTERALS INC
GE HEALTHCARE
PAR FORMULATIONS PRIVATE LTD
MOBIUS THERAPEUTICS LLC
MYLAN INSTITUTIONAL INC
ASTRAZENECA LP
ASTRAZENECA LP
ASTRAZENECA LP
ASTRAZENECA LP
ASTRAZENECA LP
ASTRAZENECA LP
ASTRAZENECA LP
AA
AA
AA
AT
AT
Page 00150
Ingredient
NALTREXONE
POTASSIUM CHLORIDE
AZITHROMYCIN
EXENATIDE SYNTHETIC
AZITHROMYCIN DIHYDRATE; TROVAFLOXACIN MESYLATE
CETYL ALCOHOL; COLFOSCERIL PALMITATE; TYLOXAPOL
DANTROLENE SODIUM
PACLITAXEL
CHLORAMPHENICOL; HYDROCORTISONE ACETATE
NITAZOXANIDE
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN; CLAVULANATE POTASSIUM
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
CEPHRADINE
CEPHRADINE
AZITHROMYCIN
AZITHROMYCIN
AZITHROMYCIN
AZITHROMYCIN
AZITHROMYCIN
AZITHROMYCIN
CEFPODOXIME PROXETIL
CLARITHROMYCIN
CLARITHROMYCIN
CLARITHROMYCIN
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
DF;Route
FOR SUSPENSION, EXTENDED RELEASE;ORAL
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS
FOR SUSPENSION, TABLET;ORAL
FOR SUSPENSION;INTRATRACHEAL
FOR SUSPENSION;INTRAVENOUS
FOR SUSPENSION;IV (INFUSION)
FOR SUSPENSION;OPHTHALMIC
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
Page 00151
Trade_Name
VIVITROL
MICRO‐K LS
QUILLIVANT XR
ZMAX
BYDUREON
TROVAN/ZITHROMAX COMPLIANCE PAK
EXOSURF NEONATAL
RYANODEX
ABRAXANE
CHLOROMYCETIN HYDROCORTISONE
ALINIA
AMCILL
AMCILL
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN AND CLAVULANATE POTASSIUM
AMOXICILLIN PEDIATRIC
AMOXIL
AMOXIL
AMOXIL
AMOXIL
AMOXIL
AMOXIL
AMOXIL
AMOXIL
ANSPOR
ANSPOR
AUGMENTIN '125'
AUGMENTIN '200'
AUGMENTIN '250'
AUGMENTIN '400'
AUGMENTIN ES‐600
AZITHROMYCIN
AZITHROMYCIN
AZITHROMYCIN
AZITHROMYCIN
AZITHROMYCIN
AZITHROMYCIN
BANAN
BANAN
BIAXIN
BIAXIN
BIAXIN
CECLOR
CECLOR
CEDAX
CEDAX
CEFACLOR
CEFACLOR
CEFACLOR
Applicant
ALKERMES
KV PHARM
NEXTWAVE PHARMS
PF PRISM CV
ASTRAZENECA AB
PFIZER
GLAXOSMITHKLINE
EAGLE PHARMS
ABRAXIS BIOSCIENCE
PARKEDALE
ROMARK
PARKE DAVIS
PARKE DAVIS
AM ANTIBIOTICS
AM ANTIBIOTICS
AUROBINDO
AUROBINDO
DAVA PHARMS INC
DAVA PHARMS INC
HIKMA
HIKMA
HIKMA
HIKMA
MYLAN
MYLAN
RANBAXY
RANBAXY
SANDOZ
SANDOZ
SANDOZ
SANDOZ
TEVA
TEVA
TEVA
TEVA
TEVA
TEVA
WOCKHARDT
HIKMA PHARMS
HIKMA PHARMS
HIKMA PHARMS
RANBAXY
RANBAXY
RANBAXY
SANDOZ
SANDOZ
SANDOZ INC
SANDOZ INC
SANDOZ INC
TEVA
TEVA
TEVA
WOCKHARDT
WOCKHARDT EU OPERATN
TEVA
DR REDDYS LABS INC
DR REDDYS LABS INC
DR REDDYS LABS INC
DR REDDYS LABS INC
DR REDDYS LABS INC
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
AM ANTIBIOTICS
AM ANTIBIOTICS
DAVA PHARMS INC
DAVA PHARMS INC
MYLAN
MYLAN
PUREPAC PHARM
PUREPAC PHARM
TEVA
TEVA
GLAXOSMITHKLINE
GLAXOSMITHKLINE
DR REDDYS LABS INC
DR REDDYS LABS INC
DR REDDYS LABS INC
DR REDDYS LABS INC
DR REDDYS LABS INC
PLIVA
PLIVA
SANDOZ
SANDOZ
TEVA PHARMS
TEVA PHARMS
SANKYO
SANKYO
ABBVIE
ABBVIE
ABBVIE
LILLY
LILLY
PERNIX THERAP
PERNIX THERAP
CLONMEL HLTHCARE
CLONMEL HLTHCARE
CLONMEL HLTHCARE
Strength
380MG/VIAL
20MEQ/PACKET
5MG/ML
EQ 2GM BASE/BOT
2MG/VIAL
EQ 1GM BASE,N/A;N/A,EQ 100MG BASE
12MG/VIAL;108MG/VIAL;8MG/VIAL
250MG/VIAL
100MG/VIAL
12.5MG/VIAL;25MG/VIAL
100MG/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
125MG/5ML
250MG/5ML
200MG/5ML
400MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
200MG/5ML
250MG/5ML
400MG/5ML
125MG/5ML
250MG/5ML
200MG/5ML
400MG/5ML
125MG/5ML
200MG/5ML
250MG/5ML
400MG/5ML
125MG/5ML
125MG/5ML
200MG/5ML
250MG/5ML
250MG/5ML
400MG/5ML
400MG/5ML
200MG/5ML;EQ 28.5MG BASE/5ML
400MG/5ML;EQ 57MG BASE/5ML
50MG/ML
50MG/ML
125MG/5ML
200MG/5ML
250MG/5ML
400MG/5ML
50MG/ML
125MG/5ML
250MG/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
125MG/5ML
250MG/5ML
EQ 100MG BASE/5ML
EQ 200MG BASE/5ML
EQ 100MG BASE/5ML
EQ 200MG BASE/5ML
EQ 100MG BASE/5ML
EQ 200MG BASE/5ML
EQ 50MG BASE/5ML
EQ 100MG BASE/5ML
125MG/5ML
187MG/5ML
250MG/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 90MG BASE/5ML
EQ 180MG BASE/5ML
EQ 125MG BASE/5ML
EQ 187MG BASE/5ML
EQ 250MG BASE/5ML
Page 00152
Appl_Type
N
N
N
N
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
A
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
A
A
A
A
A
A
N
N
N
N
N
N
N
N
N
A
A
A
21897
1
19561
3
202100
1
50797
1
22200
1
50762
1
20044
1
205579
1
21660
1
50202
1
21498
1
62030
1
62030
2
62059
1
62059
2
65334
1 AB
65334
2 AB
204030
1 AB
204030
2 AB
62927
1 AB
62927
2 AB
65322
2 AB
65325
2 AB
65322
1 AB
65325
1 AB
62090
1
62090
2
65113
1
65113
2
65387
1 AB
65378
1 AB
65387
2 AB
65378
2 AB
61931
1 AB
62946
1
65119
1 AB
61931
2 AB
63001
1
65119
2 AB
65319
2 AB
65191
2 AB
65191
1 AB
65373
1 AB
65132
1 AB
65132
2 AB
65207
2 AB
65066
1 AB
65066
2 AB
65098
1 AB
65098
2 AB
65358
1 AB
65089
1 AB
65089
2 AB
65162
1 AB
65431
1 AB
65420
1 AB
61931
3 AB
62226
5 AB
62226
1 AB
50760
1 AB
62226
2 AB
50760
2 AB
50460
5
50460
1
50460
2
61601
1
61601
2
62982
1
62982
2
61829
2
61829
1
61980
1
61980
2
61370
1
61370
2
61866
1
61866
2
50575
1 AB
50725
1 AB
50575
2 AB
50725
2 AB
50755
1 AB
65246
2 AB
65246
1 AB
65297
1
65297
2
65419
1 AB
65419
2 AB
50688
2
50688
1
50698
1 AB
50698
3
50698
2 AB
50522
1
50522
2
50686
1
50686
2
64114
1
64115
1
64116
1
Approval_Date
13‐Apr‐06
26‐Aug‐88
27‐Sep‐12
10‐Jun‐05
27‐Jan‐12
18‐Dec‐98
2‐Aug‐90
22‐Jul‐14
7‐Jan‐05
22‐Nov‐02
28‐Dec‐06
28‐Dec‐06
15‐Sep‐14
15‐Sep‐14
25‐Nov‐88
25‐Nov‐88
19‐Jun‐06
19‐Jun‐06
19‐Jun‐06
19‐Jun‐06
29‐Nov‐02
29‐Nov‐02
26‐Mar‐07
26‐Mar‐07
26‐Mar‐07
26‐Mar‐07
1‐Nov‐88
4‐Dec‐02
6‐Jan‐89
4‐Dec‐02
18‐Jun‐07
25‐Jan‐05
25‐Jan‐05
9‐Nov‐07
19‐Mar‐03
19‐Mar‐03
30‐Jan‐07
5‐Jun‐02
5‐Jun‐02
16‐Dec‐02
16‐Dec‐02
13‐Aug‐07
25‐May‐04
25‐May‐04
12‐Mar‐04
25‐Nov‐08
2‐Dec‐13
1‐Dec‐82
15‐Apr‐99
15‐Apr‐99
10‐Feb‐89
10‐Feb‐89
6‐Aug‐84
31‐May‐96
6‐Aug‐84
31‐May‐96
22‐Jun‐01
5‐Jul‐06
5‐Jul‐06
18‐Sep‐06
18‐Sep‐06
24‐Jun‐08
24‐Jun‐08
7‐Aug‐92
7‐Aug‐92
23‐Dec‐93
30‐Sep‐98
23‐Dec‐93
20‐Dec‐95
20‐Dec‐95
28‐Apr‐95
28‐Apr‐95
28‐Apr‐95
RLD
Yes
No
Yes
Yes
Yes
No
No
No
Yes
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
Yes
No
No
No
No
Type
RX
DISCN
RX
RX
RX
DISCN
DISCN
RX
RX
DISCN
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
DISCN
DISCN
RX
DISCN
RX
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
Applicant_Full_Name
ALKERMES INC
NEXTWAVE PHARMACEUTICALS INC
PF PRISM CV
ASTRAZENECA AB
GLAXOSMITHKLINE
EAGLE PHARMACEUTICALS INC
ABRAXIS BIOSCIENCE LLC
ROMARK LABORATORIES
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
WOCKHARDT EU OPERATIONS SWISS AG
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
PLIVA INC
PLIVA INC
SANDOZ INC
SANDOZ INC
SANKYO USA CORP
SANKYO USA CORP
ABBVIE INC
ABBVIE INC
ABBVIE INC
ELI LILLY AND CO
ELI LILLY AND CO
Page 00153
Ingredient
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFDINIR
CEFDINIR
CEFDINIR
CEFDINIR
CEFDINIR
CEFDINIR
CEFDINIR
CEFDINIR
CEFDINIR
CEFDINIR
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFUROXIME AXETIL
CEFUROXIME AXETIL
CEFUROXIME AXETIL
CEFUROXIME AXETIL
CEFPROZIL
CEFPROZIL
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
DF;Route
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
Page 00154
Trade_Name
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFACLOR
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFADROXIL
CEFDINIR
CEFDINIR
CEFDINIR
CEFDINIR
CEFDINIR
CEFDINIR
CEFDINIR
CEFDINIR
CEFDINIR
CEFDINIR
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFPROZIL
CEFTIN
CEFTIN
CEFUROXIME AXETIL
CEFUROXIME AXETIL
CEFZIL
CEFZIL
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
Applicant
CLONMEL HLTHCARE
FACTA FARMA
FACTA FARMA
FACTA FARMA
FACTA FARMA
RANBAXY
RANBAXY
RANBAXY
RANBAXY
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
YUNG SHIN PHARM
YUNG SHIN PHARM
YUNG SHIN PHARM
YUNG SHIN PHARM
ANI PHARMS INC
ANI PHARMS INC
ANI PHARMS INC
ANI PHARMS INC
ANI PHARMS INC
APOTHECON
APOTHECON
APOTHECON
AUROBINDO
AUROBINDO
HIKMA PHARMS
HIKMA PHARMS
LUPIN
LUPIN
ORCHID HLTHCARE
ORCHID HLTHCARE
RANBAXY
RANBAXY
RANBAXY
AUROBINDO PHARMA
AUROBINDO PHARMA
LUPIN
LUPIN
ORCHID HLTHCARE
ORCHID HLTHCARE
SANDOZ
SANDOZ
TEVA PHARMS
TEVA PHARMS
RANBAXY
RANBAXY
SANDOZ
SANDOZ
APOTEX INC
APOTEX INC
AUROBINDO PHARMA
AUROBINDO PHARMA
LUPIN
LUPIN
ORCHID HLTHCARE
ORCHID HLTHCARE
RANBAXY LABS LTD
RANBAXY LABS LTD
SANDOZ
SANDOZ
TEVA PHARMS
TEVA PHARMS
GLAXOSMITHKLINE
GLAXOSMITHKLINE
RANBAXY
RANBAXY
CORDEN PHARMA
CORDEN PHARMA
APOTHECON
APOTHECON
BARR
BARR
FACTA FARMA
FACTA FARMA
FACTA FARMA
HIKMA PHARMS
HIKMA PHARMS
LUPIN
LUPIN
ORCHID HLTHCARE
ORCHID HLTHCARE
RANBAXY
RANBAXY
TEVA
TEVA
TEVA
TEVA
TEVA
TEVA
VITARINE
VITARINE
YUNG SHIN PHARM
Strength
EQ 375MG BASE/5ML
EQ 125MG BASE/5ML
EQ 187MG BASE/5ML
EQ 250MG BASE/5ML
EQ 375MG BASE/5ML
EQ 125MG BASE/5ML
EQ 187MG BASE/5ML
EQ 250MG BASE/5ML
EQ 375MG BASE/5ML
EQ 125MG BASE/5ML
EQ 187MG BASE/5ML
EQ 250MG BASE/5ML
EQ 375MG BASE/5ML
EQ 125MG BASE/5ML
EQ 187MG BASE/5ML
EQ 250MG BASE/5ML
EQ 375MG BASE/5ML
EQ 125MG BASE/5ML
EQ 187MG BASE/5ML
EQ 250MG BASE/5ML
EQ 375MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 250MG BASE/5ML
EQ 500MG BASE/5ML
EQ 500MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 500MG BASE/5ML
EQ 250MG BASE/5ML
EQ 500MG BASE/5ML
EQ 250MG BASE/5ML
EQ 500MG BASE/5ML
EQ 250MG BASE/5ML
EQ 500MG BASE/5ML
EQ 250MG BASE/5ML
EQ 500MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 500MG BASE/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
EQ 50MG BASE/5ML
EQ 100MG BASE/5ML
EQ 50MG BASE/5ML
EQ 100MG BASE/5ML
EQ 50MG BASE/5ML
EQ 100MG BASE/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
125MG/5ML
250MG/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 100MG BASE/ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 125MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 250MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
Page 00155
Appl_Type
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
A
A
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
64110
1
62206
1
62206
3
62206
2
62206
4
64087
1
64086
1
64085
1
64070
1
64166
1
64165
1
64164
1
64155
1
64204
1
64205
1
64206
1
64207
1
65412
1 AB
65412
2 AB
65412
3 AB
65412
4 AB
62698
1
62698
2
65278
1
62698
3
65278
2
62334
1
62334
2
62334
3
65349
1 AB
65349
2 AB
91036
1 AB
91036
2 AB
65396
1 AB
65396
2 AB
65307
2 AB
65307
3 AB
65115
1
65115
2 AB
65115
3 AB
65473
1 AB
65473
2 AB
65259
1 AB
65259
2 AB
65429
1 AB
65429
2 AB
65337
1 AB
65337
2 AB
65332
1 AB
65332
2 AB
65409
1 AB
65409
2 AB
65082
1 AB
65082
2 AB
90031
1 AB
90031
2 AB
65351
1 AB
65351
2 AB
65381
1 AB
65381
2 AB
65261
1 AB
65261
2 AB
65284
2 AB
65284
1 AB
65202
1
65202
2
65257
1 AB
65257
2 AB
65236
1 AB
65236
2 AB
50672
1 AB
50672
2 AB
65323
1 AB
65323
2 AB
50665
1
50665
2
62986
1
62987
1
62778
1
62777
1
62117
1
62117
2
62117
3
65444
1
65444
2
65234
1 AB
65234
2 AB
65326
1 AB
65326
2 AB
65081
1 AB
65081
2 AB
62703
1 AB
62767
1
62873
1
62703
2 AB
62768
1
62867
1
62779
1
62781
1
65336
1
Approval_Date
28‐Apr‐95
20‐Apr‐88
20‐Apr‐88
28‐Apr‐95
28‐Apr‐95
28‐Apr‐95
28‐Apr‐95
2‐Oct‐97
2‐Oct‐97
2‐Oct‐97
2‐Oct‐97
18‐Feb‐98
18‐Feb‐98
18‐Feb‐98
18‐Feb‐98
17‐Feb‐12
17‐Feb‐12
17‐Feb‐12
17‐Feb‐12
1‐Mar‐89
1‐Mar‐89
20‐Jan‐06
1‐Mar‐89
20‐Jan‐06
25‐Apr‐13
25‐Apr‐13
28‐Nov‐12
28‐Nov‐12
21‐Feb‐08
21‐Feb‐08
16‐Oct‐06
16‐Oct‐06
26‐Mar‐03
26‐Mar‐03
26‐Mar‐03
14‐Dec‐07
14‐Dec‐07
31‐May‐06
7‐May‐07
18‐Jul‐07
18‐Jul‐07
6‐Apr‐07
6‐Apr‐07
4‐May‐07
4‐May‐07
8‐Jun‐07
8‐Jun‐07
31‐May‐02
31‐May‐02
14‐Jan‐09
14‐Jan‐09
29‐Feb‐12
29‐Feb‐12
30‐Jan‐07
30‐Jan‐07
19‐Dec‐05
19‐Dec‐05
30‐Dec‐05
30‐Dec‐05
30‐Jun‐06
30‐Jun‐06
8‐Dec‐05
8‐Dec‐05
8‐Dec‐05
8‐Dec‐05
30‐Jun‐94
29‐Apr‐97
5‐Feb‐08
5‐Feb‐08
23‐Dec‐91
23‐Dec‐91
18‐Apr‐91
25‐Jul‐89
6‐Aug‐87
6‐Aug‐87
28‐Aug‐09
28‐Aug‐09
17‐Aug‐05
17‐Aug‐05
10‐Jul‐06
10‐Jul‐06
27‐Jul‐01
27‐Jul‐01
13‐Feb‐87
16‐Jun‐87
23‐May‐88
13‐Feb‐87
16‐Jun‐87
15‐Apr‐88
22‐Dec‐87
22‐Dec‐87
25‐Jul‐07
RLD
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
Yes
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
Type
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
Applicant_Full_Name
LUPIN LTD
LUPIN LTD
ORCHID HEALTHCARE
ORCHID HEALTHCARE
LUPIN LTD
LUPIN LTD
ORCHID HEALTHCARE
ORCHID HEALTHCARE
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
APOTEX INC
APOTEX INC
LUPIN LTD
LUPIN LTD
ORCHID HEALTHCARE
ORCHID HEALTHCARE
SANDOZ INC
SANDOZ INC
GLAXOSMITHKLINE
GLAXOSMITHKLINE
LUPIN LTD
LUPIN LTD
ORCHID HEALTHCARE
ORCHID HEALTHCARE
Page 00156
Ingredient
CEPHALEXIN
CEPHRADINE
CEPHRADINE
CEPHRADINE
CEPHRADINE
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CLARITHROMYCIN
CLARITHROMYCIN
CLARITHROMYCIN
CLARITHROMYCIN
CYCLACILLIN
CYCLACILLIN
CYCLACILLIN
FLUCONAZOLE
FLUCONAZOLE
DOXYCYCLINE
DOXYCYCLINE
DOXYCYCLINE
FAMOTIDINE
FAMOTIDINE
FAMOTIDINE
FLUCONAZOLE
FLUCONAZOLE
FLUCONAZOLE
FLUCONAZOLE
FLUCONAZOLE
FLUCONAZOLE
FLUCONAZOLE
FLUCONAZOLE
FLUCONAZOLE
FLUCONAZOLE
CEPHALEXIN
CEPHALEXIN
CEPHALEXIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
LORACARBEF
LORACARBEF
FOSFOMYCIN TROMETHAMINE
CEFDINIR
CEFDINIR
FAMOTIDINE
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
SEVELAMER CARBONATE
SEVELAMER CARBONATE
SILDENAFIL CITRATE
BACAMPICILLIN HYDROCHLORIDE
DF;Route
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
Page 00157
Trade_Name
CEPHALEXIN
CEPHRADINE
CEPHRADINE
CEPHRADINE
CEPHRADINE
CIPRO
CIPRO
CIPROFLOXACIN
CIPROFLOXACIN
CLARITHROMYCIN
CLARITHROMYCIN
CLARITHROMYCIN
CLARITHROMYCIN
Applicant
YUNG SHIN PHARM
BARR
BARR
TEVA
TEVA
BAYER HLTHCARE
BAYER HLTHCARE
LUPIN LTD
LUPIN LTD
RANBAXY
RANBAXY
SANDOZ
SANDOZ
Strength
EQ 250MG BASE/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
250MG/5ML
500MG/5ML
250MG/5ML
500MG/5ML
125MG/5ML
250MG/5ML
125MG/5ML
250MG/5ML
CO‐LAV
VINTAGE PHARMS
COLOVAGE
CYCLAPEN‐W
CYCLAPEN‐W
CYCLAPEN‐W
DIFLUCAN
DIFLUCAN
DOXYCHEL
DOXYCYCLINE
DOXYCYCLINE
DURICEF
DURICEF
DURICEF
DYNAPEN
DYNAPHARM
WYETH AYERST
WYETH AYERST
WYETH AYERST
APOTHECON
PFIZER
PFIZER
RACHELLE
CHARTWELL LIFE SCI
LUPIN LTD
WARNER CHILCOTT
WARNER CHILCOTT
WARNER CHILCOTT
APOTHECON
125MG/5ML
250MG/5ML
500MG/5ML
EQ 62.5MG BASE/5ML
50MG/5ML
200MG/5ML
EQ 25MG BASE/5ML
EQ 25MG BASE/5ML
EQ 25MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 500MG BASE/5ML
EQ 62.5MG BASE/5ML
E‐Z‐EM PREP LYTE
FAMOTIDINE
FAMOTIDINE
FAMOTIDINE
FLUCONAZOLE
FLUCONAZOLE
FLUCONAZOLE
FLUCONAZOLE
FLUCONAZOLE
FLUCONAZOLE
FLUCONAZOLE
FLUCONAZOLE
FLUCONAZOLE
FLUCONAZOLE
E Z EM
HI‐TECH PHARMA CO
LUPIN LTD
NAVINTA LLC
AUROBINDO PHARM
AUROBINDO PHARM
RANBAXY
RANBAXY
ROXANE
ROXANE
TARO PHARM INDS
TARO PHARM INDS
40MG/5ML
40MG/5ML
40MG/5ML
50MG/5ML
200MG/5ML
50MG/5ML
200MG/5ML
50MG/5ML
200MG/5ML
50MG/5ML
200MG/5ML
50MG/5ML
200MG/5ML
GLYCOPREP
GOLDLINE
GO‐EVAC
ILOSONE
KEFLEX
KEFLEX
KEFLEX
LAROTID
LAROTID
LAROTID
LORABID
LORABID
MONUROL
OMNICEF
OMNICEF
PATHOCIL
VINTAGE PHARMS
DISTA
SHIONOGI INC
SHIONOGI INC
SHIONOGI INC
DR REDDYS LABS INC
DR REDDYS LABS INC
GLAXOSMITHKLINE
KING PHARMS
KING PHARMS
ZAMBON SPA
PAR PHARM
PAR PHARM
ABBVIE
ABBVIE
WYETH AYERST
WYETH AYERST
WYETH AYERST
WYETH AYERST
WYETH AYERST
EQ 125MG BASE/5ML
EQ 100MG BASE/ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
125MG/5ML
250MG/5ML
50MG/ML
100MG/5ML
200MG/5ML
EQ 3GM BASE/PACKET
20MG/PACKET;1.68GM/PACKET
125MG/5ML
250MG/5ML
100MG/ML
125MG/5ML
250MG/5ML
500MG/5ML
EQ 62.5MG BASE/5ML
PEG‐LYTE
PENBRITIN
PENBRITIN
PENBRITIN
PEPCID
PFIZERPEN‐A
PFIZERPEN‐A
POLYCILLIN
POLYCILLIN
POLYCILLIN
POLYCILLIN
POLYCILLIN
POLYCILLIN
POLYCILLIN‐PRB
POLYCILLIN‐PRB
POLYMOX
POLYMOX
POLYMOX
POLYMOX
PRINCIPEN
PRINCIPEN
PRINCIPEN
PRINCIPEN '125'
PRINCIPEN '125'
PRINCIPEN '250'
PRINCIPEN '250'
PROBAMPACIN
RENVELA
RENVELA
REVATIO
SPECTROBID
SANDOZ
WYETH AYERST
WYETH AYERST
WYETH AYERST
SALIX PHARMS
PFIZER
PFIZER
APOTHECON
APOTHECON
BRISTOL
BRISTOL
BRISTOL
BRISTOL
APOTHECON
BRISTOL
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
TEVA
GENZYME
GENZYME
PFIZER
PFIZER
EQ 100MG BASE/ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
40MG/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 100MG BASE/ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 500MG BASE/5ML
EQ 3.5GM BASE/BOT;1GM/BOT
125MG/5ML
125MG/5ML
250MG/5ML
250MG/5ML
EQ 100MG BASE/ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 125MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 250MG BASE/5ML
2.4GM/PACKET
800MG/PACKET
EQ 10MG BASE/ML
125MG/5ML
Page 00158
Appl_Type
A
A
A
A
A
N
N
A
A
A
A
A
A
65336
2
62858
1
62859
1
62693
1
62693
2
20780
1 AB
20780
2 AB
200563
1 AB
200563
2 AB
65382
1 AB
65382
2 AB
65283
2 AB
65283
3 AB
Approval_Date
25‐Jul‐07
19‐May‐88
19‐May‐88
9‐Jan‐87
9‐Jan‐87
26‐Sep‐97
26‐Sep‐97
5‐Mar‐14
5‐Mar‐14
30‐Aug‐07
30‐Aug‐07
4‐Sep‐07
4‐Sep‐07
RLD
No
No
No
No
No
No
Yes
No
No
No
No
No
No
28‐Jan‐92 No
Type
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
Applicant_Full_Name
LUPIN LTD
LUPIN LTD
SANDOZ INC
SANDOZ INC
A
73428
1
A
N
N
N
A
N
N
A
A
A
N
N
N
N
71320
50508
50508
50508
61455
20090
20090
61720
65454
201678
50527
50527
50527
50337
1
1
2
3
1
1
2
1
1
1
2
3
1
2
A
A
A
A
A
A
A
A
A
A
A
A
A
A
71278
201995
90440
91020
79150
79150
77523
77523
76332
76332
76246
76246
76918
76918
1
1
1
1
1
2
1
2
1
2
1
2
1
2
A
72319
1
A
A
N
N
N
A
A
N
N
N
N
A
A
N
N
A
A
A
A
N
73433
61893
50406
50406
50406
62226
62226
50460
50667
50667
50717
79182
79182
50749
50749
60625
60625
60625
60625
50092
1
1
3
1
2
3 AB
4 AB
6
1
2
1
1
2
1
2
1
2
3
4
1
28‐Apr‐92
31‐Dec‐91
31‐Dec‐91
19‐Dec‐96
19‐Apr‐13
19‐Apr‐13
4‐Dec‐97
29‐Jul‐04
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
VINTAGE PHARMACEUTICALS
DISTA PRODUCTS CO DIV ELI LILLY AND CO
SHIONOGI INC
SHIONOGI INC
SHIONOGI INC
GLAXOSMITHKLINE
ZAMBON SPA ITALY
ABBVIE INC
ABBVIE INC
A
N
N
N
N
A
A
A
A
N
N
N
N
A
N
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
73098
50019
50019
50019
19527
62049
62049
62297
62297
50308
50308
50308
50308
61898
50457
61851
62323
61851
62323
61394
61394
61394
60127
62151
60127
62151
61741
22318
22318
203109
50556
1
1
2
3
1 AB
1
2
1
2
4
1
2
3
1
1
1
1
2
2
1
2
3
2
1
1
2
1
2
1
1
1
31‐Aug‐93
2‐Feb‐87
18‐Feb‐09
12‐Aug‐09
30‐Aug‐12
23‐Mar‐82
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
Yes
No
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
SANDOZ INC
GENZYME CORP
GENZYME CORP
PFIZER INC
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
DISCN VINTAGE PHARMACEUTICALS
20‐Apr‐88
23‐Dec‐93
23‐Dec‐93
16‐Jul‐08
18‐Mar‐13
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DYNAPHARM INC
LUPIN LTD
WARNER CHILCOTT INC
WARNER CHILCOTT INC
WARNER CHILCOTT INC
21‐Nov‐88
30‐May‐14
29‐Jun‐10
27‐May‐10
18‐Sep‐09
18‐Sep‐09
12‐Sep‐07
12‐Sep‐07
29‐Jul‐04
29‐Jul‐04
29‐Jul‐04
29‐Jul‐04
18‐Dec‐06
18‐Dec‐06
No
No
No
No
No
No
No
No
No
No
No
No
No
No
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
E Z EM CO INC
HI‐TECH PHARMACAL CO INC
LUPIN LTD
NAVINTA LLC
23‐Dec‐88 No
DISCN GOLDLINE LABORATORIES INC
Page 00159
Ingredient
CEFIXIME
CEFIXIME
CEFIXIME
CEFIXIME
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
AMOXICILLIN
PENICILLIN V
CEPHRADINE
CEPHRADINE
HETACILLIN
HETACILLIN
HETACILLIN
HETACILLIN
VORICONAZOLE
DOXYCYCLINE
VORICONAZOLE
AMOXICILLIN
AMOXICILLIN
AZITHROMYCIN
AZITHROMYCIN
AZITHROMYCIN
LINEZOLID
NITRIC OXIDE
NITRIC OXIDE
KRYPTON, KR‐81M
XENON XE‐127
XENON XE‐127
XENON XE‐133
XENON XE‐133
XENON XE‐133
XENON XE‐133
XENON XE‐133
XENON XE‐133
XENON XE‐133
XENON XE‐133
XENON XE‐133
XENON XE‐133
CYANOCOBALAMIN
TESTOSTERONE
TESTOSTERONE
TESTOSTERONE
ESTRADIOL
ESTRADIOL
TESTOSTERONE
OXYBUTYNIN
TESTOSTERONE
TESTOSTERONE
SODIUM MONOFLUOROPHOSPHATE
DINOPROSTONE
LIDOCAINE HYDROCHLORIDE
LOTEPREDNOL ETABONATE
PILOCARPINE HYDROCHLORIDE
GANCICLOVIR
DIAZEPAM
DF;Route
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
FOR SUSPENSION;ORAL
GAS;INHALATION
GAS;INHALATION
GAS;INHALATION
GAS;INHALATION
GAS;INHALATION
GAS;INHALATION
GAS;INHALATION
GAS;INHALATION
GAS;INHALATION
GAS;INHALATION
GAS;INHALATION
GAS;INHALATION
GAS;INHALATION
GAS;INHALATION
GAS;INHALATION
GEL, AUGMENTED;TOPICAL
GEL, METERED;NASAL
GEL, METERED;NASAL
GEL, METERED;TRANSDERMAL
GEL;DENTAL
GEL;ENDOCERVICAL
GEL;OPHTHALMIC
GEL;OPHTHALMIC
GEL;OPHTHALMIC
GEL;OPHTHALMIC
GEL;PERIODONTAL
GEL;RECTAL
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
DAPSONE
ADAPALENE
ADAPALENE
ADAPALENE
TRETINOIN
TRETINOIN
GEL;RECTAL
GEL;RECTAL
GEL;RECTAL
GEL;RECTAL
GEL;RECTAL
GEL;RECTAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
Page 00160
Trade_Name
SUPRAX
SUPRAX
SUPRAX
SUPRAX
TAMIFLU
TAMIFLU
TOTACILLIN
TOTACILLIN
TOTACILLIN
TOTACILLIN
TRIMOX
TRIMOX
TRIMOX
TRIMOX
TRIMOX
TRIMOX
TRIMOX
TRIMOX
TRIMOX
ULTRACEF
ULTRACEF
ULTRACEF
UTIMOX
UTIMOX
V‐CILLIN
VANTIN
VANTIN
VELOSEF '125'
VELOSEF '250'
VERSAPEN
VERSAPEN
VERSAPEN
VERSAPEN
VFEND
VIBRAMYCIN
VORICONAZOLE
WELCHOL
WELCHOL
WYMOX
WYMOX
ZEGERID
ZEGERID
ZEGERID OTC
ZITHROMAX
ZITHROMAX
ZITHROMAX
ZYVOX
INOMAX
INOMAX
MPI KRYPTON 81M GENERATOR
XENON XE 127
XENON XE 127
XENON XE 133
XENON XE 133
XENON XE 133
XENON XE 133
XENON XE 133
XENON XE 133
XENON XE 133
XENON XE 133
XENON XE 133
XENON XE 133‐V.S.S.
DIPROLENE
NASCOBAL
NATESTO
ANDROGEL
ANDROGEL
ELESTRIN
ESTROGEL
FORTESTA
GELNIQUE 3%
TESTOSTERONE
VOGELXO
EXTRA‐STRENGTH AIM
PREPIDIL
AKTEN
LOTEMAX
PILOPINE HS
ZIRGAN
ORAQIX
DIASTAT
Applicant
LEDERLE
LUPIN LTD
LUPIN PHARMS
LUPIN PHARMS
ROCHE
ROCHE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
BRISTOL
BRISTOL
BRISTOL
PARKE DAVIS
PARKE DAVIS
LILLY
APOTHECON
APOTHECON
BRISTOL
BRISTOL
BRISTOL
BRISTOL
PF PRISM CV
PFIZER
MYLAN PHARMS INC
DAIICHI SANKYO
DAIICHI SANKYO
WYETH AYERST
WYETH AYERST
SANTARUS INC
SANTARUS INC
MSD CONSUMER
PFIZER
PFIZER
PFIZER
INO
INO
GE HEALTHCARE
MALLINCKRODT
MALLINCKRODT
GE HEALTHCARE
GE HEALTHCARE
GE HEALTHCARE
GEN ELECTRIC
GEN ELECTRIC
LANTHEUS MEDCL
LANTHEUS MEDCL
MALLINCKRODT
MALLINCKRODT
GE HEALTHCARE
FOUGERA PHARMS
TARO
SCHERING
PAR PHARM
TRIMEL BIOPHARMA SRL
ABBVIE
ABBVIE
MEDA PHARMS
ASCEND THERAPS US
ENDO PHARMS
WATSON LABS INC
PERRIGO ISRAEL
UPSHER SMITH
CHESEBROUGH PONDS
AKORN
BAUSCH AND LOMB INC
ALCON
BAUSCH AND LOMB
DENTSPLY PHARM
VALEANT
DIASTAT
DIASTAT
DIASTAT
DIASTAT
DIASTAT ACUDIAL
DIASTAT ACUDIAL
ACANYA
ACZONE
ADAPALENE
ADAPALENE
ADAPALENE
ARISTOGEL
ATRALIN
AVITA
BENZACLIN
BENZACLIN
VALEANT
VALEANT
VALEANT
VALEANT
VALEANT
VALEANT
DOW PHARM
ALLERGAN
GLENMARK GENERICS
PLIVA HRVATSKA DOO
TOLMAR
ASTELLAS
DOW PHARM
MYLAN
VALEANT BERMUDA
VALEANT BERMUDA
Strength
100MG/5ML
500MG/5ML
100MG/5ML
200MG/5ML
EQ 6MG BASE/ML
EQ 12MG BASE/ML
EQ 125MG BASE/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 250MG BASE/5ML
50MG/ML
125MG/5ML
125MG/5ML
125MG/5ML
125MG/5ML
250MG/5ML
250MG/5ML
250MG/5ML
250MG/5ML
EQ 125MG BASE/5ML
EQ 250MG BASE/5ML
EQ 500MG BASE/5ML
125MG/5ML
250MG/5ML
125MG/0.6ML
EQ 50MG BASE/5ML
EQ 100MG BASE/5ML
125MG/5ML
250MG/5ML
EQ 112.5MG AMPICIL/ML
EQ 112.5MG AMPICIL/5ML
EQ 112.5MG AMPICIL/ML
EQ 225MG AMPICIL/5ML
200MG/5ML
EQ 25MG BASE/5ML
200MG/5ML
1.875GM/PACKET
3.75GM/PACKET
125MG/5ML
250MG/5ML
EQ 1GM BASE/PACKET
EQ 100MG BASE/5ML
EQ 200MG BASE/5ML
100MG/5ML
100PPM
800PPM
N/A
5mCi/VIAL
10mCi/VIAL
1 CI/AMP
10mCi/VIAL
20mCi/VIAL
5‐100 CI/CYLINDER
0.25‐5 CI/AMP
10mCi/VIAL
20mCi/VIAL
10mCi/VIAL
20mCi/VIAL
10mCi/VIAL
EQ 0.05% BASE
EQ 0.05% BASE
EQ 0.05% BASE
0.5MG/INH
5.5MG/0.122GM ACTUATION
1.62% (20.25MG/1.25GM ACTUATION)
0.06% (0.87GM/ACTIVATION)
0.06% (1.25GM/ACTIVATION)
10MG/0.5GM ACTUATION
3%
1.20%
0.5MG/3GM
3.50%
0.50%
4%
0.15%
2.5%;2.5%
2.5MG/0.5ML (5MG/ML)
5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
10MG/2ML (5MG/ML)
15MG/3ML (5MG/ML)
20MG/4ML (5MG/ML)
10MG/2ML (5MG/ML)
20MG/4ML (5MG/ML)
2.5%;1.2%
5%
0.10%
0.10%
0.30%
0.10%
0.05%
0.03%
5%;EQ 1% BASE
5%;EQ 1% BASE
Page 00161
Appl_Type
N
N
A
A
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
A
A
A
N
N
A
N
N
A
N
N
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
A
N
N
N
N
50622
1
202091
1
65129
1
65355
1
21246
2
21246
1
60666
1
62223
1
60666
2
62223
2
61886
1
61886
2
62099
1
62154
1
62885
1
61886
3
62099
2
62154
2
62885
2
62376
1
62376
2
62376
3
62127
1
62127
2
60002
1
50675
1
50675
2
61763
1
61763
2
61398
1
50060
1
50060
3
61398
2
21630
1 AB
50006
1 AB
202361
1 AB
22362
1
22362
2
62131
1
62131
2
21636
1
21636
2
22283
1
50693
1
50710
1 AB
50710
2 AB
21132
1
20845
2
20845
3
18088
1
18536
1
18536
2
17256
2
17687
2
17687
3
17550
1
17550
3
17284
1
17284
2 AA
18327
1
18327
2
17687
1
75276
1 AB
76508
1 AB
19408
2
19722
1
205488
1
22309
1
21015
3 AB
21813
1
21166
2
21463
1
202513
1
203098
1 AB
204399
3
19518
2
19617
1
22221
1
202872
1
18796
1
22211
1
21451
1
20648
1
20648
20648
20648
20648
20648
20648
50819
21794
91314
90962
200298
83380
22070
20400
50756
50756
2
3
4
5
7
6
1
1
1
1
1
1
1
1
1
2
AB
AB
AB
BT
AB
Approval_Date
28‐Apr‐89
20‐Feb‐13
23‐Feb‐04
10‐Apr‐07
21‐Mar‐11
14‐Dec‐00
8‐Mar‐88
8‐Mar‐88
16‐Mar‐82
16‐Mar‐82
16‐Mar‐82
7‐Aug‐92
7‐Aug‐92
19‐Dec‐03
28‐May‐13
2‐Oct‐09
2‐Oct‐09
15‐Jun‐04
21‐Dec‐04
17‐Jun‐13
28‐Sep‐94
19‐Oct‐95
19‐Oct‐95
18‐Apr‐00
23‐Dec‐99
23‐Dec‐99
1‐Oct‐82
1‐Oct‐82
9‐Mar‐82
9‐Mar‐82
13‐May‐03
2‐Dec‐03
22‐Nov‐91
5‐Nov‐96
28‐May‐14
29‐Apr‐11
26‐Sep‐03
15‐Dec‐06
9‐Feb‐04
29‐Dec‐10
7‐Dec‐11
31‐Jan‐13
4‐Jun‐14
6‐Aug‐86
9‐Dec‐92
7‐Oct‐08
28‐Sep‐12
1‐Oct‐84
15‐Sep‐09
19‐Dec‐03
29‐Jul‐97
RLD
No
Yes
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
No
Yes
No
No
No
Yes
Yes
Yes
No
Yes
Yes
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
No
Type
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
OTC
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
Applicant_Full_Name
LUPIN LTD
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
ELI LILLY AND CO
PF PRISM CV
DAIICHI SANKYO INC
DAIICHI SANKYO INC
SANTARUS INC
SANTARUS INC
MSD CONSUMER CARE INC
PFIZER CENTRAL RESEARCH
INO THERAPEUTICS INC
INO THERAPEUTICS INC
GE HEALTHCARE
GE HEALTHCARE
GE HEALTHCARE
GE HEALTHCARE
GENERAL ELECTRIC CO
GENERAL ELECTRIC CO
LANTHEUS MEDICAL IMAGING INC
GE HEALTHCARE
TRIMEL BIOPHARMA SRL
ABBVIE INC
ABBVIE INC
ASCEND THERAPEUTICS US LLC
CHESEBROUGH PONDS INC
AKORN INC
BAUSCH AND LOMB INC
ALCON LABORATORIES INC
BAUSCH AND LOMB INC
DENTSPLY PHARMACEUTICAL INC
29‐Jul‐97
29‐Jul‐97
29‐Jul‐97
29‐Jul‐97
15‐Sep‐05
15‐Sep‐05
23‐Oct‐08
7‐Jul‐05
1‐Jul‐10
2‐Jun‐10
14‐Jun‐12
26‐Jul‐07
29‐Jan‐98
21‐Dec‐00
20‐Apr‐07
No
No
No
No
No
Yes
Yes
Yes
No
No
No
No
Yes
No
Yes
No
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
DISCN
ALLERGAN INC
PLIVA HRVATSKA DOO
TOLMAR INC
Page 00162
Ingredient
BENZOYL PEROXIDE; ERYTHROMYCIN
CICLOPIROX
CICLOPIROX
CICLOPIROX
PODOFILOX
DEXAMETHASONE
DESONIDE
DESOXIMETASONE
DESOXIMETASONE
DICLOFENAC SODIUM
ADAPALENE
ADAPALENE
ERYTHROMYCIN
ERYTHROMYCIN
ADAPALENE; BENZOYL PEROXIDE
ERYTHROMYCIN
ERYTHROMYCIN
ERYTHROMYCIN
ESTRADIOL
AZELAIC ACID
FLUOCINONIDE
FLUOCINONIDE
FLUOCINONIDE
TERBINAFINE
TERBINAFINE
DF;Route
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
FLUOCINONIDE
CICLOPIROX
METRONIDAZOLE
METRONIDAZOLE
METRONIDAZOLE
METRONIDAZOLE
METRONIDAZOLE
METRONIDAZOLE
METRONIDAZOLE
BRIMONIDINE TARTRATE
HYDROCORTISONE
ALITRETINOIN
HYDROCORTISONE
INGENOL MEBUTATE
INGENOL MEBUTATE
TRETINOIN
TRETINOIN
TRETINOIN
TRETINOIN
TRETINOIN
DICLOFENAC SODIUM
BEXAROTENE
TAZAROTENE
TAZAROTENE
DESOXIMETASONE
DESOXIMETASONE
TRETINOIN
TRETINOIN
TRETINOIN
TRETINOIN
BETAMETHASONE BENZOATE
MECHLORETHAMINE HYDROCHLORIDE
CLINDAMYCIN PHOSPHATE; TRETINOIN
DICLOFENAC SODIUM
KETOCONAZOLE
CLINDAMYCIN PHOSPHATE; TRETINOIN
TESTOSTERONE
TESTOSTERONE
TESTOSTERONE
TESTOSTERONE
ESTRADIOL
ESTRADIOL
ESTRADIOL
OXYBUTYNIN CHLORIDE
TESTOSTERONE
TESTOSTERONE
TESTOSTERONE
TESTOSTERONE
TESTOSTERONE
TESTOSTERONE
TESTOSTERONE
TESTOSTERONE
TESTOSTERONE
TESTOSTERONE
PROGESTERONE
PROGESTERONE
METRONIDAZOLE
METRONIDAZOLE
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TOPICAL
GEL;TRANSDERMAL
GEL;TRANSDERMAL
GEL;TRANSDERMAL
GEL;TRANSDERMAL
GEL;TRANSDERMAL
GEL;TRANSDERMAL
GEL;TRANSDERMAL
GEL;TRANSDERMAL
GEL;TRANSDERMAL
GEL;TRANSDERMAL
GEL;TRANSDERMAL
GEL;TRANSDERMAL
GEL;TRANSDERMAL
GEL;TRANSDERMAL
GEL;TRANSDERMAL
GEL;TRANSDERMAL
GEL;TRANSDERMAL
GEL;TRANSDERMAL
GEL;VAGINAL
GEL;VAGINAL
GEL;VAGINAL
GEL;VAGINAL
Page 00163
Trade_Name
BENZAMYCIN
BENZAMYCIN PAK
CICLOPIROX
CICLOPIROX
CICLOPIROX
CLEOCIN T
CLINDAGEL
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
CONDYLOX
DECADERM
DESONATE
DESOXIMETASONE
DESOXIMETASONE
DICLOFENAC SODIUM DIFFERIN
DIFFERIN
DUAC
E‐GLADES
EMBELINE
EMGEL
EPIDUO
ERYGEL
ERYTHROMYCIN
ERYTHROMYCIN
ERYTHROMYCIN AND BENZOYL PEROXIDE
ESTROGEL
FINACEA
FLUOCINONIDE
FLUOCINONIDE
FLUOCINONIDE
FLUONID
LAMISIL
LAMISIL AT
Applicant
VALEANT INTL
VALEANT LUXEMBOURG
FOUGERA PHARMS
GLENMARK GENERICS
PADDOCK LLC
PRECISION DERMAT
FOUGERA PHARMS
MYLAN PHARMS INC
PERRIGO ISRAEL
FOUGERA PHARMS
PERRIGO
TARO
WATSON PHARMS
MERCK
BAYER HLTHCARE
PERRIGO NEW YORK
VERSAPHARM
TOLMAR
GALDERMA LABS LP
GALDERMA LABS LP
STIEFEL
RENAISSANCE PHARMA
HI TECH PHARMA
ALTANA
GALDERMA LABS LP
DELCOR ASSET CORP
FOUGERA PHARMS
PERRIGO
TOLMAR
ASCEND THERAPS US
BAYER HLTHCARE
FOUGERA
TARO
TEVA
ALLERGAN HERBERT
NOVARTIS
NOVARTIS
LIDEX
LOPROX
METROGEL
METROGEL
METRONIDAZOLE
METRONIDAZOLE
METRONIDAZOLE
METRONIDAZOLE
METRONIDAZOLE
MIRVASO
NAFTIN
NAFTIN
NUTRACORT
PANRETIN
PENECORT
PICATO
PICATO
RETIN‐A
RETIN‐A
RETIN‐A MICRO
RETIN‐A MICRO
RETIN‐A‐MICRO
SOLARAZE
TARGRETIN
TAZORAC
TAZORAC
TEMOVATE
TOPICORT
TOPICORT
TRETINOIN
TRETINOIN
TRETINOIN
TRETINOIN
UTICORT
VALCHLOR
VELTIN
VOLTAREN
XOLEGEL
ZIANA
ANDROGEL
ANDROGEL
ANDROGEL
ANDROGEL
DIVIGEL
DIVIGEL
DIVIGEL
GELNIQUE
TESTIM
TESTOSTERONE
TESTOSTERONE
TESTOSTERONE
TESTOSTERONE
TESTOSTERONE
TESTOSTERONE
TESTOSTERONE
TESTOSTERONE
VOGELXO
CRINONE
CRINONE
METROGEL‐VAGINAL
METRONIDAZOLE
CNTY LINE PHARMS
CNTY LINE PHARMS
GALDERMA LABS LP
GALDERMA LABS LP
FOUGERA PHARMS
G AND W LABS INC
TARO
TOLMAR
TOLMAR
GALDERMA LABS LP
MERZ PHARMS
MERZ PHARMS
HEALTHPOINT
EISAI INC
ALLERGAN HERBERT
LEO PHARMA AS
LEO PHARMA AS
VALEANT INTL
VALEANT INTL
VALEANT INTL
VALEANT INTL
VALEANT INTL
FOUGERA PHARMS
VALEANT LUXEMBOURG
ALLERGAN
ALLERGAN
FOUGERA PHARMS
TARO
TARO PHARMS NORTH
MATAWAN PHARMS
MATAWAN PHARMS
SPEAR PHARMS INC
SPEAR PHARMS INC
PARKE DAVIS
ACTELION PHARMS LTD
STIEFEL GSK
NOVARTIS
AQUA PHARMS
MEDICIS
ABBVIE
ABBVIE
ABBVIE
ABBVIE
VERTICAL PHARMS LLC
VERTICAL PHARMS LLC
VERTICAL PHARMS LLC
WATSON LABS
AUXILIUM PHARMS
PAR PHARM
PAR PHARM
PERRIGO ISRAEL
PERRIGO ISRAEL
TEVA PHARMS
TEVA PHARMS
WATSON LABS
WATSON LABS
UPSHER SMITH
WATSON LABS
WATSON LABS
MEDICIS
TOLMAR
Strength
5%;3%
5%;3%
0.77%
0.77%
0.77%
EQ 1% BASE
EQ 1% BASE
EQ 1% BASE
5%;EQ 1% BASE
5%;1.2%
0.05%
0.05%
0.05%
0.50%
0.10%
0.05%
0.05%
0.05%
3%
0.10%
0.30%
5%;1.2%
2%
0.05%
2%
0.1%;2.5%
2%
2%
2%
5%;3%
0.06%
15%
0.05%
0.05%
0.05%
0.03%
1%
1%
0.77%
0.75%
1%
0.75%
0.75%
0.75%
0.75%
1%
EQ 0.33% BASE
1%
2%
1%
EQ 0.1% BASE
1%
0.02%
0.05%
0.01%
0.03%
0.04%
0.10%
0.08%
3%
1%
0.05%
0.10%
0.05%
0.05%
0.05%
0.01%
0.03%
0.04%
0.10%
0.03%
EQ 0.016% BASE
1.2%;0.025%
1%
2%
1.2%;0.025%
1.62% (20.25MG/1.25GM PACKET)
1.62% (40.5MG/2.5GM PACKET)
25MG/2.5GM PACKET
50MG/5GM PACKET
0.1% (0.25GM/PACKET)
0.1% (0.5GM/PACKET)
0.1% (1GM/PACKET)
10%(100MG/PACKET)
1% (50MG/5GM PACKET)
1% (2.5GM/PACKET)
1% (5GM/PACKET)
25MG/2.5GM PACKET
50MG/5GM PACKET
25MG/2.5GM PACKET
50MG/5GM PACKET
1% (2.5GM/PACKET)
1% (5GM/PACKET)
50MG/5GM PACKET
4%
8%
0.75%
0.75%
Page 00164
Appl_Type
N
N
A
A
A
N
N
A
A
A
A
A
A
N
N
N
A
A
A
N
N
N
A
A
A
N
N
A
A
A
N
N
A
A
A
A
N
N
N
N
N
N
A
A
A
A
A
N
N
N
A
N
A
N
N
N
N
N
N
N
N
N
N
N
N
A
N
A
A
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
N
N
N
N
A
A
N
N
N
N
A
50557
1 AB
50769
1
77896
1 AB
91595
1 AB
78266
1 AB
50615
1 AB
50782
1 BT
64160
1 AB
65443
1 AB
90979
1 AB
75368
1 AB
75027
1 AB
75279
1 AB
20529
1
13538
1
21844
1
77552
1 AB
90727
1 AB
200936
1 AB
20380
1 AB
21753
1 AB
50741
1 AB
65009
1
76141
1 AB
63107
1
22320
1
50617
1 AT
64184
1 AT
63211
1 AT
65112
1 AB
21166
1
21470
1
72933
1 AB
74935
1 AB
72537
1 AB
87300
1
20846
1
21958
1
17373
20519
19737
21789
77018
78178
77819
77547
90903
204708
19356
204286
84698
20886
88215
202833
202833
17955
17579
20475
20475
20475
21005
21056
20600
20600
20337
74904
18586
75589
75529
202567
202026
17244
202317
50803
22122
21946
50802
22309
22309
21015
21015
22038
22038
22038
22204
21454
76744
76744
203098
203098
202763
202763
76737
76737
204399
20701
20701
20208
77264
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
2
1
2
2
1
3
1
1
1
2
1
1
1
1
1
1
1
1
1
1
1
1
1
2
3
1
2
1
2
3
1
1
1
2
2
3
1
2
1
2
2
1
2
1
1
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
AB
BX
BX
AB
AB
BX
AB
AB
BX
BX
AB
AB
Approval_Date
26‐Oct‐84
27‐Nov‐00
10‐Jun‐08
29‐Feb‐12
7‐Jan‐09
7‐Jan‐87
27‐Nov‐00
28‐Jan‐00
11‐Aug‐09
26‐Jun‐12
15‐Feb‐00
31‐Oct‐97
28‐May‐99
13‐Mar‐97
20‐Oct‐06
9‐Jan‐06
10‐Mar‐11
28‐Oct‐13
31‐May‐96
19‐Jun‐07
26‐Aug‐02
18‐Mar‐02
12‐Apr‐02
23‐Aug‐91
8‐Dec‐08
21‐Oct‐87
30‐Sep‐97
29‐Jan‐93
29‐Mar‐04
9‐Feb‐04
24‐Dec‐02
30‐Dec‐94
29‐Jul‐97
7‐Feb‐89
27‐May‐82
29‐Apr‐98
24‐Jul‐06
RLD
Yes
Yes
No
No
No
Yes
Yes
No
No
No
No
No
No
Yes
No
Yes
No
No
No
Yes
Yes
Yes
No
No
No
Yes
Yes
No
No
No
No
Yes
No
Yes
No
No
No
Yes
Type
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
DISCN
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
DISCN
DISCN
OTC
Applicant_Full_Name
VALEANT INTERNATIONAL SRL
PERRIGO CO
MERCK AND CO INC
VERSAPHARM INC
TOLMAR INC
ALTANA INC
DELCOR ASSET CORP
PERRIGO CO
TOLMAR INC
ASCEND THERAPEUTICS US LLC
21‐Jul‐97
22‐Nov‐88
30‐Jun‐05
6‐Jun‐06
19‐Jan‐11
18‐Jul‐06
13‐Jul‐06
22‐Jul‐11
23‐Aug‐13
18‐Jun‐90
27‐Jun‐13
2‐Feb‐99
6‐Jun‐84
23‐Jan‐12
23‐Jan‐12
10‐May‐02
7‐Feb‐97
28‐Jan‐14
16‐Oct‐00
28‐Jun‐00
13‐Jun‐97
13‐Jun‐97
29‐Apr‐94
14‐Jul‐98
29‐Mar‐82
11‐Jun‐02
22‐Feb‐00
17‐Jul‐13
17‐Jul‐13
23‐Aug‐13
16‐Jul‐10
17‐Oct‐07
28‐Jul‐06
7‐Nov‐06
7‐Sep‐12
7‐Sep‐12
28‐Feb‐00
28‐Feb‐00
4‐Jun‐07
4‐Jun‐07
4‐Jun‐07
27‐Jan‐09
31‐Oct‐02
23‐May‐07
23‐May‐07
31‐Jan‐13
31‐Jan‐13
14‐Feb‐12
14‐Feb‐12
27‐Jan‐06
27‐Jan‐06
4‐Jun‐14
31‐Jul‐97
31‐Jul‐97
17‐Aug‐92
31‐Oct‐06
No
Yes
Yes
Yes
No
No
No
No
No
Yes
Yes
Yes
No
Yes
No
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
No
Yes
No
Yes
No
No
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
TOLMAR INC
TOLMAR INC
HEALTHPOINT LTD
EISAI INC
ALLERGAN HERBERT SKIN CARE DIV ALLERGAN INC
LEO PHARMA AS
LEO PHARMA AS
ALLERGAN INC
ALLERGAN INC
TARO PHARMACEUTICALS, INC.
ACTELION PHARMACEUTICALS LTD
STIEFEL A GSK CO
AQUA PHARMACEUTICALS LLC
ABBVIE INC
ABBVIE INC
ABBVIE INC
ABBVIE INC
VERTICAL PHARMACEUTICALS LLC
AUXILIUM PHARMACEUTICALS INC
PAR PHARMACEUTICAL
PAR PHARMACEUTICAL
WATSON LABORATORIES
WATSON LABORATORIES
TOLMAR INC
Page 00165
Ingredient
METRONIDAZOLE
METRONIDAZOLE
AMINOSALICYLIC ACID
SODIUM BICARBONATE; TARTARIC ACID
COLESTIPOL HYDROCHLORIDE
ERYTHROMYCIN ETHYLSUCCINATE
ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL
MONTELUKAST SODIUM
MONTELUKAST SODIUM
MONTELUKAST SODIUM
IPODATE CALCIUM
MONTELUKAST SODIUM
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
ETONOGESTREL
DF;Route
GEL;VAGINAL
GEL;VAGINAL
GRANULE, DELAYED RELEASE;ORAL
GRANULE, EFFERVESCENT;ORAL
GRANULE, EFFERVESCENT;ORAL
GRANULE;ORAL
GRANULE;ORAL
GRANULE;ORAL
GRANULE;ORAL
GRANULE;ORAL
GRANULE;ORAL
GRANULE;ORAL
GRANULE;ORAL
GRANULE;ORAL
GRANULE;ORAL
GRANULE;ORAL
GRANULE;ORAL
GRANULE;ORAL
GRANULE;ORAL
GRANULE;ORAL
GRANULE;ORAL
GRANULE;ORAL
GRANULE;ORAL
GRANULE;ORAL
GRANULE;ORAL
GRANULE;ORAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
GUM, CHEWING;BUCCAL
IMPLANT;IMPLANTATION
LEVONORGESTREL
LEVONORGESTREL
ETONOGESTREL
LEVONORGESTREL
LEVONORGESTREL
LEUPROLIDE ACETATE
GANCICLOVIR
GOSERELIN ACETATE
GOSERELIN ACETATE
CARMUSTINE
DEXAMETHASONE
HISTRELIN ACETATE
HISTRELIN ACETATE
NICOTINE
AMPHOTERICIN B
AMPHOTERICIN B
AMPHOTERICIN B
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
AMPHOTERICIN B
DAUNORUBICIN CITRATE
CYTARABINE
DOXORUBICIN HYDROCHLORIDE
BUPIVACAINE
BUPIVACAINE
VINCRISTINE SULFATE
LEUPROLIDE ACETATE; NORETHINDRONE ACETATE
LEUPROLIDE ACETATE; NORETHINDRONE ACETATE
HYDROCORTISONE SODIUM SUCCINATE
IMPLANT;INTRACRANIAL
IMPLANT;INTRAVITREAL
IMPLANT;SUBCUTANEOUS
IMPLANT;SUBCUTANEOUS
INHALANT;ORAL
INJECTABLE, LIPID COMPLEX;INJECTION
INJECTABLE, LIPOSOMAL;EPIDURAL
INJECTABLE, LIPOSOMAL;INJECTION
INJECTABLE, LIPOSOMAL;INTRAVENOUS
INJECTABLE, TABLET;INTRAMUSCULAR, ORAL
INJECTABLE, TABLET;INTRAMUSCULAR, ORAL
INJECTABLE;INJECTION
Page 00166
Trade_Name
METRONIDAZOLE
VANDAZOLE
PASER
BAROS
ZANTAC 150
COLESTID
COLESTID
E.E.S.
ERYPED
ERYPED
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL
ERYZOLE
FLAVORED COLESTID
FLAVORED COLESTID
LAMISIL
LAMISIL
MONTELUKAST SODIUM
MONTELUKAST SODIUM
MONTELUKAST SODIUM
ORAGRAFIN CALCIUM
PEDIAMYCIN
PEDIAZOLE
SINGULAIR
NICORETTE
NICORETTE
NICORETTE
NICORETTE
NICORETTE (MINT)
NICORETTE (MINT)
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
NICOTINE POLACRILEX
THRIVE
THRIVE
IMPLANON
Applicant
WATSON LABS INC
TEVA PHARMS
JACOBUS
MALLINCKRODT INC
GLAXO GRP LTD
IMPAX LABS
IMPAX LABS
ARBOR PHARMS LLC
ARBOR PHARMS LLC
ARBOR PHARMS LLC
BARR
BARR
ALRA
NOVARTIS
NOVARTIS
DR REDDYS LABS LTD
MYLAN PHARMS INC
TEVA PHARMS
BRACCO
ROSS LABS
ROSS LABS
MERCK
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
PERRIGO
PERRIGO
PERRIGO
PERRIGO
PERRIGO
PERRIGO
PERRIGO R AND D
PERRIGO R AND D
PERRIGO R AND D
PERRIGO R AND D
PERRIGO R AND D
PERRIGO R AND D
PERRIGO R AND D
PERRIGO R AND D
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
NOVARTIS
NOVARTIS
ORGANON USA INC
JADELLE
LEVONORGESTREL
NEXPLANON
NORPLANT
NORPLANT SYSTEM IN PLASTIC CONTAINER
VIADUR
VITRASERT
ZOLADEX
ZOLADEX
GLIADEL
ILUVIEN
OZURDEX
RETISERT
SUPPRELIN LA
VANTAS
NICOTROL
ABELCET
AMPHOTEC
AMPHOTEC
DEPODUR
DEPODUR
DEPODUR
AMBISOME
DAUNOXOME
DEPOCYT
DOXIL (LIPOSOMAL)
DOXIL (LIPOSOMAL)
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
EXPAREL
EXPAREL
MARQIBO KIT
LUPANETA PACK
LUPANETA PACK
A‐HYDROCORT
A‐HYDROCORT
POPULATION COUNCIL
WYETH PHARMS INC
ORGANON USA INC
POPULATION COUNCIL
WYETH PHARMS INC
ORTHO MCNEIL JANSSEN
BAUSCH AND LOMB
ASTRAZENECA
ASTRAZENECA
ARBOR PHARMS LLC
ALIMERA SCIENCES INC
ALLERGAN
BAUSCH AND LOMB
ENDO PHARM
ENDO PHARM
SIGMA TAU
ALKOPHARMA USA
ALKOPHARMA USA
PACIRA PHARMS INC
PACIRA PHARMS INC
PACIRA PHARMS INC
ASTELLAS
GALEN (UK)
PACIRA PHARMS INC
JANSSEN RES AND DEV
JANSSEN RES AND DEV
SUN PHARMA GLOBAL
SUN PHARMA GLOBAL
PACIRA PHARMS INC
PACIRA PHARMS INC
TALON THERAP
ABBVIE ENDOCRINE
ABBVIE ENDOCRINE
ABBOTT
ABBOTT
Strength
1.30%
0.75%
4GM/PACKET
460MG/GM;420MG/GM
EQ 150MG BASE/PACKET
5GM/SCOOPFUL
5GM/PACKET
5GM/SCOOPFUL
5GM/PACKET
EQ 200MG BASE/5ML
EQ 200MG BASE/5ML
EQ 400MG BASE/5ML
EQ 200MG BASE/5ML
EQ 200MG BASE/5ML;EQ 600MG BASE/5ML
5GM/PACKET
5GM/SCOOPFUL
EQ 125MG BASE/PACKET
EQ 4MG BASE/PACKET
EQ 4MG BASE/PACKET
EQ 4MG BASE/PACKET
3GM/PACKET
EQ 200MG BASE/5ML
EQ 4MG BASE/PACKET
EQ 2MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 4MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 4MG BASE
EQ 4MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 4MG BASE
EQ 4MG BASE
EQ 4MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 2MG BASE
EQ 4MG BASE
EQ 4MG BASE
EQ 4MG BASE
EQ 4MG BASE
EQ 4MG BASE
EQ 4MG BASE
EQ 2MG BASE
EQ 4MG BASE
68MG/IMPLANT
75MG/IMPLANT **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
75MG/IMPLANT
68MG/IMPLANT
36MG/IMPLANT
36MG/IMPLANT
EQ 65MG BASE
4.5MG
EQ 3.6MG BASE
EQ 10.8MG BASE
7.7MG
0.19MG
0.7MG
0.59MG
50MG
50MG
4MG/CARTRIDGE
5MG/ML
50MG/VIAL
100MG/VIAL
10MG/ML (10MG/ML)
15MG/1.5ML (10MG/ML)
20MG/2ML (10MG/ML)
50MG/VIAL
EQ 2MG BASE/ML
10MG/ML
20MG/10ML (2MG/ML)
50MG/25ML (2MG/ML)
20MG/10ML (2MG/ML)
50MG/25ML (2MG/ML)
133MG/10ML (13.3MG/ML)
266MG/20ML (13.3MG/ML)
5MG/5ML (1MG/ML)
3.75MG/VIAL,N/A;N/A,5MG
11.25MG/VIAL,N/A;N/A,5MG
EQ 1GM BASE/VIAL
EQ 100MG BASE/VIAL
Page 00167
Appl_Type
N
N
A
N
N
N
N
A
A
N
N
N
A
A
A
N
N
N
N
A
A
A
N
A
N
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
N
N
N
N
N
A
A
205223
1
21806
1 BX
74346
1
18509
1
20251
2
17563
3 AB
17563
4 AB
77277
1 AB
77277
2 AB
50207
1 AB
50207
3 AB
50207
2
62055
1
62759
1
62758
1
17563
1
17563
2
22071
1
22071
2
202906
1 AB
202776
1 AB
90955
1 AB
12968
1
62305
1
50529
1
21409
1 AB
18612
2
18612
4
20066
2
20066
4
18612
3
20066
3
76880
1
77850
1
76775
1
76776
1
76777
1
76778
1
76779
1
76789
1
78325
1
78547
1
78967
1
91349
1
78326
1
78546
1
78968
1
91354
1
74507
1
76568
1
76569
1
78699
1
79044
1
79216
1
74707
1
76568
2
76569
2
78697
1
79038
1
79219
1
77658
1
77656
1
21529
1
20544
20627
21529
19897
20088
21088
20569
19726
20578
20637
201923
22315
21737
22058
21732
20714
50724
50729
50729
21671
21671
21671
50740
50704
21041
50718
50718
203263
203263
22496
22496
202497
203696
203696
89580
85928
1
1
2
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
2
1
2
3
1
2
1
1
2
1
2
1
2
1
1
2
1
1
AB
AB
AB
AB
Approval_Date
24‐Mar‐14
20‐May‐05
30‐Jun‐94
7‐Aug‐85
31‐Mar‐94
22‐Sep‐95
22‐Sep‐95
2‐May‐06
2‐May‐06
30‐Mar‐87
20‐May‐88
15‐Jun‐88
28‐Sep‐07
28‐Sep‐07
17‐Sep‐12
18‐Dec‐12
3‐Aug‐12
26‐Jul‐02
9‐Feb‐96
25‐Sep‐00
9‐Feb‐96
25‐Sep‐00
23‐Dec‐98
23‐Dec‐98
18‐Feb‐09
18‐Feb‐09
16‐Sep‐04
16‐Sep‐04
16‐Sep‐04
16‐Sep‐04
16‐Sep‐04
16‐Sep‐04
30‐Oct‐06
24‐May‐07
23‐Apr‐08
20‐Jul‐11
30‐Oct‐06
24‐May‐07
23‐Apr‐08
20‐Jul‐11
15‐Mar‐99
29‐Jul‐04
29‐Jul‐04
29‐Dec‐08
8‐Jul‐09
8‐Jul‐09
19‐Mar‐99
29‐Jul‐04
29‐Jul‐04
29‐Dec‐08
8‐Jul‐09
8‐Jul‐09
19‐Jun‐07
19‐Jun‐07
17‐Jul‐06
RLD
Yes
No
Yes
No
No
No
Yes
No
No
No
No
Yes
No
Yes
No
No
No
No
Yes
No
No
No
No
No
No
Yes
Yes
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Type
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
OTC
OTC
OTC
OTC
OTC
OTC
OTC
OTC
OTC
OTC
OTC
OTC
OTC
OTC
OTC
OTC
OTC
OTC
OTC
OTC
OTC
OTC
OTC
DISCN
OTC
OTC
OTC
OTC
OTC
OTC
DISCN
OTC
OTC
OTC
OTC
OTC
RX
Applicant_Full_Name
JACOBUS PHARMACEUTICAL CO
MALLINCKRODT INC
ROSS LABORATORIES DIV ABBOTT LABORATORIES INC
ROSS LABORATORIES DIV ABBOTT LABORATORIES INC
MERCK RESEARCH LABORATORIES DIV MERCK CO INC
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
PERRIGO CO
PERRIGO CO
PERRIGO CO
PERRIGO CO
PERRIGO CO
PERRIGO CO
PERRIGO R AND D CO
PERRIGO R AND D CO
PERRIGO R AND D CO
PERRIGO R AND D CO
PERRIGO R AND D CO
PERRIGO R AND D CO
PERRIGO R AND D CO
PERRIGO R AND D CO
ORGANON USA INC
1‐Nov‐96
15‐Aug‐96
31‐May‐11
10‐Dec‐90
10‐Dec‐90
3‐Mar‐00
4‐Mar‐96
29‐Dec‐89
11‐Jan‐96
23‐Sep‐96
26‐Sep‐14
17‐Jun‐09
8‐Apr‐05
3‐May‐07
12‐Oct‐04
2‐May‐97
20‐Nov‐95
22‐Nov‐96
22‐Nov‐96
18‐May‐04
18‐May‐04
18‐May‐04
11‐Aug‐97
8‐Apr‐96
1‐Apr‐99
17‐Nov‐95
13‐Jun‐00
4‐Feb‐13
4‐Feb‐13
28‐Oct‐11
28‐Oct‐11
9‐Aug‐12
14‐Dec‐12
14‐Dec‐12
11‐Apr‐89
No
No
Yes
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
Yes
Yes
Yes
No
No
Yes
Yes
No
Yes
Yes
No
Yes
No
No
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
DISCN
DISCN
POPULATION COUNCIL CENTER FOR BIOMEDICAL RESEARCH
ORGANON USA INC
POPULATION COUNCIL
ORTHO MCNEIL JANSSEN PHARMACEUTICAL INC
BAUSCH AND LOMB INC
ASTRAZENECA UK LTD
ASTRAZENECA UK LTD
ALIMERA SCIENCES INC
ALLERGAN INC
BAUSCH AND LOMB INC
ENDO PHARMACEUTICAL SOLUTIONS INC
ENDO PHARMACEUTICAL SOLUTIONS INC
ALKOPHARMA USA INC
ALKOPHARMA USA INC
PACIRA PHARMACEUTICALS INC
GALEN LTD
JANSSEN RESEARCH AND DEVELOPMENT LLC
JANSSEN RESEARCH AND DEVELOPMENT LLC
TALON THERAPEUTICS INC
ABBVIE ENDOCRINE INC
ABBVIE ENDOCRINE INC
ABBOTT LABORATORIES HOSP PRODUCTS DIV
Page 00168
Ingredient
METHYLPREDNISOLONE SODIUM SUCCINATE
TECHNETIUM TC‐99M ALBUMIN AGGREGATED KIT
GONADOTROPIN, CHORIONIC
METHOTREXATE SODIUM
METHOTREXATE SODIUM
METHOTREXATE SODIUM
METHOTREXATE SODIUM
SOMATROPIN RECOMBINANT
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
ACETAZOLAMIDE SODIUM
PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE
PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE
ARGATROBAN
CORTICOTROPIN
CORTICOTROPIN
CORTICOTROPIN
CORTICOTROPIN
SERACTIDE ACETATE
SERACTIDE ACETATE
CORTICORELIN OVINE TRIFLUTATE
TECHNETIUM TC‐99M APCITIDE
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
PEGADEMASE BOVINE
ADENOSINE
ADENOSINE
ADENOSINE
ADENOSINE
ADENOSINE
ADENOSINE
ADENOSINE
ADENOSINE
ADENOSINE
ADENOSINE
ADENOSINE
ADENOSINE
ADENOSINE
FLUOROURACIL
FLUOROURACIL
FLUOROURACIL
FLUOROURACIL
POLYMYXIN B SULFATE
TIROFIBAN HYDROCHLORIDE
DF;Route
Page 00169
Trade_Name
A‐HYDROCORT
A‐HYDROCORT
A‐HYDROCORT
A‐HYDROCORT
A‐HYDROCORT
A‐HYDROCORT
A‐HYDROCORT
A‐HYDROCORT
A‐METHAPRED
A‐METHAPRED
A‐METHAPRED
A‐METHAPRED
A‐METHAPRED
A‐METHAPRED
A‐METHAPRED
A‐METHAPRED
A‐METHAPRED
A‐METHAPRED
A‐METHAPRED
A‐METHAPRED
A‐METHAPRED
A‐METHAPRED
A‐N STANNOUS AGGREGATED ALBUMIN
A.P.L.
A.P.L.
A.P.L.
ABITREXATE
ABITREXATE
ABITREXATE
ABITREXATE
ACCRETROPIN
ACETATED RINGER'S IN PLASTIC CONTAINER
ACHROMYCIN
ACHROMYCIN
ACHROMYCIN
ACHROMYCIN
ACOVA
ACTH
ACTH
ACTHAR
ACTHAR
ACTHAR GEL‐SYNTHETIC
ACTHAR GEL‐SYNTHETIC
ACTHREL
ACUTECT
ACYCLOVIR
ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE
ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ACYCLOVIR SODIUM
ADAGEN
ADENOCARD
ADENOSINE
ADENOSINE
ADENOSINE
ADENOSINE
ADENOSINE
ADENOSINE
ADENOSINE
ADENOSINE
ADENOSINE
ADENOSINE
ADENOSINE
ADENOSINE
ADRIAMYCIN PFS
ADRIAMYCIN PFS
ADRIAMYCIN PFS
ADRIAMYCIN PFS
ADRIAMYCIN RDF
ADRIAMYCIN RDF
ADRIAMYCIN RDF
ADRIAMYCIN RDF
ADRUCIL
ADRUCIL
ADRUCIL
ADRUCIL
AEROSPORIN
AGGRASTAT
AGGRASTAT
AGGRASTAT
Applicant
ABBOTT
ABBOTT
ABBOTT
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
ABBOTT
ABBOTT
ABBOTT
ABBOTT
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA INC
HOSPIRA INC
SYNCOR PHARMS
FERRING
FERRING
FERRING
ABIC
ABIC
ABIC
ABIC
EMERGENT
B BRAUN
EUROHLTH INTL
HOSPIRA
SAGENT AGILA
X GEN PHARMS
LEDERLE
LEDERLE
LEDERLE
LEDERLE
PFIZER
PARKEDALE
PARKEDALE
SANOFI AVENTIS US
SANOFI AVENTIS US
ARMOUR PHARM
ARMOUR PHARM
FERRING
CIS BIO INTL SA
ABBVIE
HIKMA MAPLE HIKMA MAPLE APOTHECON
APOTHECON
BEDFORD
BEDFORD
FRESENIUS KABI USA
FRESENIUS KABI USA
HIKMA MAPLE HIKMA MAPLE HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
TEVA PARENTERAL
TEVA PARENTERAL
TEVA PARENTERAL
SIGMA TAU
ASTELLAS
AGILA SPECLTS
AGILA SPECLTS
AKORN
BEDFORD
FRESENIUS KABI USA
GLAND PHARMA LTD
HIKMA MAPLE HIKMA MAPLE LUITPOLD
TEVA PHARMS USA
TEVA PHARMS USA
WOCKHARDT
TEVA PARENTERAL
TEVA PARENTERAL
GLAXOSMITHKLINE
MEDICURE
MEDICURE
MEDICURE
Strength
EQ 100MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 100MG BASE/VIAL
EQ 100MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 40MG BASE/VIAL
EQ 125MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 40MG BASE/VIAL
EQ 40MG BASE/VIAL
EQ 125MG BASE/VIAL
EQ 125MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 40MG BASE/VIAL
EQ 125MG BASE/VIAL
N/A
5,000 UNITS/VIAL
10,000 UNITS/VIAL
20,000 UNITS/VIAL
EQ 25MG BASE/ML
EQ 50MG BASE/VIAL
EQ 100MG BASE/VIAL
EQ 250MG BASE/VIAL
5MG/ML (5MG/ML)
20MG/100ML;30MG/100ML;380MG/100ML;600MG/100ML
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
40MG/VIAL;100MG/VIAL
40MG/VIAL;250MG/VIAL
250MG/VIAL
500MG/VIAL
250MG/2.5ML (100MG/ML)
25 UNITS/VIAL
40 UNITS/VIAL
25 UNITS/VIAL
40 UNITS/VIAL
40 UNITS/ML
80 UNITS/ML
EQ 0.1MG BASE/VIAL
N/A
EQ 50MG BASE/ML
EQ 1GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 50MG BASE/ML
EQ 1GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 50MG BASE/ML
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 25MG BASE/ML
EQ 50MG BASE/ML
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 50MG BASE/ML
EQ 500MG BASE/VIAL
250 UNITS/ML
3MG/ML
3MG/ML
3MG/ML
3MG/ML
3MG/ML
3MG/ML
3MG/ML
3MG/ML
3MG/ML
3MG/ML
3MG/ML
3MG/ML
3MG/ML
2MG/ML
2MG/ML
200MG/100ML
200MG/100ML
10MG/VIAL
20MG/VIAL
50MG/VIAL
150MG/VIAL
50MG/ML
50MG/ML
50MG/ML
50MG/ML
EQ 500,000 U BASE/VIAL
EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)
EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)
EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)
Page 00170
Appl_Type
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
A
A
A
A
N
N
A
A
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
N
A
N
N
N
N
N
A
N
A
A
A
N
N
N
89577
1
89578
1
89579
1
85932
1
40666
1 AP
85929
1
85930
1
85931
1
89576
1
89573
1
89574
1
89575
1
85852
1
89174
1
40664
1 AP
85853
1
40665
1 AP
85855
1
85854
1
89173
1
40793
1 AP
40827
1 AP
17916
1
17055
1
17055
2
17055
3
89161
1
89354
1
89355
1
89356
1
21538
1
18725
1
40089
1 AP
40108
1
200880
1 AP
40784
1 AP
50276
1
50276
3
50273
2
50273
3
20883
1 AP
8317
2
8317
4
7504
2
7504
3
17861
1
17861
2
20162
1
20887
1
75114
1
74885
2
74885
1
74897
2
74897
1
203701
1 AP
74596
1
74596
2 AP
74930
1 AP
75015
1 AP
74913
2
74913
1
74663
2
74758
2
74720
1
75065
1
74663
1
74758
1
74969
2
75627
1
74969
1
19818
1
19937
2 AP
78640
1 AP
78686
1 AP
78076
1 AP
76404
1 AP
77133
1 AP
77283
1 AP
76500
1 AP
76501
1
90010
1 AP
76564
1
78676
1
90220
1 AP
63165
1
50629
1
63165
2
50629
2
50467
1
50467
3
50467
2
50467
4
81222
1
17959
1
40023
1
81225
1
62036
1
20913
2
20912
1
20913
3
Approval_Date
11‐Apr‐89
11‐Apr‐89
11‐Apr‐89
6‐Apr‐06
22‐Feb‐91
22‐Feb‐91
22‐Feb‐91
22‐Feb‐91
18‐Aug‐87
20‐Dec‐05
20‐Dec‐05
18‐Aug‐87
25‐Nov‐08
25‐Nov‐08
10‐Mar‐87
17‐Jul‐87
17‐Jul‐87
17‐Jul‐87
23‐Jan‐08
29‐Nov‐82
28‐Feb‐95
30‐Oct‐95
9‐May‐12
10‐Dec‐08
30‐Jun‐00
23‐May‐96
14‐Sep‐98
26‐Jul‐99
19‐Dec‐97
19‐Dec‐97
27‐Feb‐98
27‐Feb‐98
11‐Oct‐13
22‐Apr‐97
22‐Apr‐97
13‐May‐98
30‐Apr‐98
15‐Oct‐97
15‐Oct‐97
22‐Apr‐97
22‐Apr‐97
22‐Apr‐97
25‐Feb‐99
22‐Apr‐97
22‐Apr‐97
26‐Aug‐97
28‐Mar‐01
26‐Aug‐97
21‐Mar‐90
30‐Oct‐89
21‐Mar‐14
13‐May‐09
31‐Oct‐08
16‐Jun‐04
27‐Apr‐05
14‐Jun‐07
16‐Jun‐04
16‐Jun‐04
28‐Apr‐09
16‐Jun‐04
31‐Jul‐08
20‐Jul‐09
30‐Jan‐91
23‐Dec‐87
30‐Jan‐91
3‐May‐88
20‐May‐85
22‐Jul‐87
28‐Jun‐91
18‐Oct‐91
28‐Aug‐91
17‐May‐02
14‐May‐98
20‐Apr‐00
RLD
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
Yes
No
No
No
No
No
No
Yes
No
No
No
Yes
No
No
No
Yes
No
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Type
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
Applicant_Full_Name
HOSPIRA WORLDWIDE, INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
SYNCOR PHARMACEUTICALS INC
FERRING PHARMACEUTICALS INC
ABIC LTD
ABIC LTD
ABIC LTD
ABIC LTD
EMERGENT BIOSOLUTIONS INC
B BRAUN MEDICAL INC
EUROHEALTH INTERNATIONAL SARL
HOSPIRA INC
SAGENT AGILA LLC
X GEN PHARMACEUTICALS INC
PFIZER INC
ARMOUR PHARMACEUTICAL CO
CIS BIO INTERNATIONAL SA
ABBVIE INC
HIKMA MAPLE LTD
HIKMA MAPLE LTD
BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
TEVA PARENTERAL MEDICINES INC
AGILA SPECIALTIES PRIVATE LTD
AKORN INC
GLAND PHARMA LTD
HIKMA MAPLE LTD
HIKMA MAPLE LTD
LUITPOLD PHARMACEUTICALS INC
WOCKHARDT LTD
GLAXOSMITHKLINE
MEDICURE INTERNATIONAL INC
Page 00171
Ingredient
BIPERIDEN LACTATE
ALCOHOL; DEXTROSE
ALCOHOL; DEXTROSE
ALCOHOL; DEXTROSE
ALCOHOL
ALCOHOL; DEXTROSE
METHYLDOPATE HYDROCHLORIDE
ALFENTANIL HYDROCHLORIDE
ALFENTANIL HYDROCHLORIDE
MELPHALAN HYDROCHLORIDE
ALLOPURINOL SODIUM
ALLOPURINOL SODIUM
LIDOCAINE HYDROCHLORIDE
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
HYDROXOCOBALAMIN
ALPROSTADIL
ALPROSTADIL
TECHNETIUM TC‐99M MEDRONATE KIT
DF;Route
AMINOCAPROIC ACID
ETOMIDATE
AMIFOSTINE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMINO ACIDS
AMINO ACIDS
AMINO ACIDS
AMINOCAPROIC ACID
AMINOCAPROIC ACID
AMINOCAPROIC ACID
AMINOCAPROIC ACID
AMINOCAPROIC ACID
AMINOHIPPURATE SODIUM
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
PROTEIN HYDROLYSATE
AMINO ACIDS
AMINO ACIDS
AMINO ACIDS
AMINO ACIDS
AMINO ACIDS
AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE
AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE
Page 00172
Trade_Name
AGGRASTAT
AKINETON
ALCOHOL 10% AND DEXTROSE 5%
ALCOHOL 5% AND DEXTROSE 5%
ALCOHOL 5% IN D5‐W
ALCOHOL 5% IN DEXTROSE 5%
ALCOHOL 5% IN DEXTROSE 5% IN WATER
ALDOMET
ALFENTA
ALFENTANIL
ALKERAN
ALLOPURINOL SODIUM
ALOPRIM
ALPHACAINE HYDROCHLORIDE
ALPHACAINE HYDROCHLORIDE W/ EPINEPHRINE
ALPHACAINE HYDROCHLORIDE W/ EPINEPHRINE
ALPHAREDISOL
ALPROSTADIL
ALPROSTADIL
AMERSCAN MDP KIT
Applicant
MEDICURE
ABBVIE
B BRAUN
B BRAUN
HOSPIRA
MILES
BAXTER HLTHCARE
MERCK
AKORN
HOSPIRA
GLAXOSMITHKLINE
EUROHLTH INTL
MYLAN INSTITUTIONAL
CARLISLE
CARLISLE
CARLISLE
MERCK
EUROHLTH INTL
TEVA PHARMS USA
GE HEALTHCARE
Strength
EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML)
5MG/ML
10ML/100ML;5GM/100ML
5ML/100ML;5GM/100ML
5ML/100ML;5GM/100ML
5ML/100ML
5ML/100ML;5GM/100ML
50MG/ML
EQ 0.5MG BASE/ML
EQ 0.5MG BASE/ML
EQ 50MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
AMICAR
AMIDATE
AMIFOSTINE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE
AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AMIKIN
AMIKIN
AMIKIN
AMIKIN
AMIKIN
AMIKIN
AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AMINESS 5.2% ESSENTIAL AMINO ACIDS W/ HISTADINE
AMINO ACIDS
AMINO ACIDS
AMINOCAPROIC ACID
AMINOCAPROIC ACID
AMINOCAPROIC ACID
AMINOCAPROIC ACID
AMINOCAPROIC ACID IN PLASTIC CONTAINER
AMINOHIPPURATE SODIUM
AMINOPHYLLIN
AMINOPHYLLIN
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45%
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45%
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AMINOSOL 5%
AMINOSYN 10%
AMINOSYN 10% (PH6)
AMINOSYN 3.5%
AMINOSYN 3.5% IN PLASTIC CONTAINER
AMINOSYN 3.5% IN PLASTIC CONTAINER
CLOVER PHARMS
HOSPIRA
SUN PHARMA GLOBAL
ABBOTT
ABBOTT
ASTRAZENECA
ASTRAZENECA
EMCURE PHARMS LTD
EUROHLTH INTL
EUROHLTH INTL
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
TEVA PHARMS USA
TEVA PHARMS USA
HOSPIRA
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
HOSPIRA
B BRAUN
B BRAUN
ABRAXIS PHARM
BAXTER HLTHCARE
HOSPIRA
LUITPOLD
HOSPIRA
MERCK
GD SEARLE LLC
GD SEARLE LLC
ABRAXIS PHARM
ABRAXIS PHARM
ABRAXIS PHARM
ABRAXIS PHARM
ABRAXIS PHARM
ELKINS SINN
HOSPIRA
HOSPIRA
INTL MEDICATION
INTL MEDICATION
INTL MEDICATION
KING PHARMS
LUITPOLD
LUITPOLD
LYPHOMED
PHARMA SERVE NY
PHARMA SERVE NY
SMITH AND NEPHEW
SMITH AND NEPHEW
TEVA PARENTERAL
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
ABBVIE
HOSPIRA
HOSPIRA
HOSPIRA
ABBOTT
ABBOTT
2%
0.01MG/ML;2%
0.02MG/ML;2%
1MG/ML
0.5MG/ML
0.5MG/ML
N/A
2MG/ML
500MG/VIAL
EQ 250MG BASE/ML
EQ 250MG BASE/ML
EQ 50MG BASE/ML
EQ 250MG BASE/ML
EQ 250MG BASE/ML
EQ 50MG BASE/ML
EQ 250MG BASE/ML
EQ 50MG BASE/ML
EQ 250MG BASE/ML
EQ 50MG BASE/ML
EQ 50MG BASE/ML
EQ 62.5MG BASE/ML
EQ 250MG BASE/ML
EQ 250MG BASE/ML
EQ 250MG BASE/ML
EQ 250MG BASE/ML
EQ 50MG BASE/ML
EQ 250MG BASE/ML
EQ 500MG BASE/100ML
EQ 50MG BASE/ML
EQ 50MG BASE/ML
EQ 50MG BASE/ML
EQ 250MG BASE/ML
EQ 250MG BASE/ML
EQ 250MG BASE/ML
EQ 5MG BASE/ML
EQ 10MG BASE/ML
5.2% (5.2GM/100ML)
15%(150GM/1000ML)
15%(300GM/2000ML)
250MG/ML
250MG/ML
250MG/ML
250MG/ML
250MG/ML
20%
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
100MG/100ML
200MG/100ML
100MG/100ML
200MG/100ML
400MG/100ML
500MG/100ML
5%
10% (10GM/100ML)
10% (10GM/100ML)
3.5% (3.5GM/100ML)
3.5% (3.5GM/100ML)
3.5% (3.5GM/100ML)
AMINOSYN 3.5% M
AMINOSYN 3.5% M
HOSPIRA
HOSPIRA
3.5%;21MG/100ML;40MG/100ML;128MG/100ML;234MG/100ML
3.5%;21MG/100ML;128MG/100ML;234MG/100ML
AMINOSYN 3.5% M IN PLASTIC CONTAINER
ABBOTT
Page 00173
Appl_Type
N
N
N
N
A
A
A
N
N
A
N
A
N
A
A
A
A
A
A
N
20913
1
12418
2
4589
6
4589
4 AP
83263
1
83483
1
83256
1
13401
1
19353
1 AP
75221
1 AP
20207
1 AP
76870
1 AP
20298
1 AP
84721
1
84720
1
84732
1
80778
1
74815
1 AP
75196
1 AP
18335
1
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
A
A
N
N
N
N
A
A
A
N
A
A
A
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
N
N
N
15229
18227
77126
63265
63266
63167
63169
204040
63313
63315
63274
63275
63263
63350
63283
63264
63350
64098
64099
64045
64045
64146
62311
62562
50495
62311
62562
50495
50618
50618
18901
91112
91112
70522
18590
70888
71192
70010
5619
87243
87621
84568
87200
87250
87886
88407
87239
87242
87601
87209
87867
87868
86606
87240
87600
87431
87387
87392
88429
88749
81142
88147
88147
18924
18924
18924
18924
5932
17673
17673
17789
18804
18875
2
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
2
1
1
1
2
1
1
1
1
2
2
2
2
1
1
1
2
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
2
3
1
2
3
4
12
3
8
4
1
1
N
N
17789
17789
3
5
N
18804
2
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
Approval_Date
14‐May‐98
29‐Dec‐86
28‐Oct‐99
18‐Nov‐92
26‐Aug‐04
17‐May‐96
20‐Jan‐98
30‐Apr‐99
5‐Aug‐82
RLD
No
No
Yes
Yes
No
No
No
No
Yes
No
Yes
No
Yes
No
No
No
No
No
No
No
Type
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
Applicant_Full_Name
ABBVIE INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
MILES LABORATORIES INC
BAXTER HEALTHCARE CORP
MERCK AND CO INC
AKORN INC
HOSPIRA INC
GLAXOSMITHKLINE
MYLAN INSTITUTIONAL LLC
CARLISLE LABORATORIES INC
MERCK AND CO INC
GE HEALTHCARE
7‐Sep‐82
14‐Mar‐08
30‐Nov‐94
31‐Oct‐94
14‐Dec‐95
14‐Dec‐95
12‐Dec‐13
11‐Apr‐94
11‐Apr‐94
18‐May‐92
18‐May‐92
30‐Nov‐94
30‐Jul‐93
31‐Oct‐94
30‐Nov‐94
30‐Jul‐93
26‐Jun‐95
20‐Jun‐95
28‐Sep‐93
28‐Sep‐93
2‐Apr‐97
20‐Sep‐84
20‐Sep‐84
30‐Nov‐87
30‐Nov‐87
6‐Apr‐84
13‐Apr‐12
13‐Apr‐12
17‐Jun‐86
29‐Oct‐82
16‐Jun‐88
1‐Dec‐87
9‐Mar‐87
24‐May‐82
24‐May‐82
6‐Jan‐82
30‐Aug‐83
25‐Jan‐84
26‐Oct‐83
23‐Jul‐82
1‐Feb‐82
10‐Nov‐83
10‐Nov‐83
3‐Jun‐83
15‐Dec‐83
30‐May‐85
30‐May‐85
25‐Sep‐91
3‐May‐83
3‐May‐83
12‐Dec‐84
12‐Dec‐84
12‐Dec‐84
12‐Dec‐84
31‐Jan‐85
18‐Nov‐85
15‐May‐84
8‐Aug‐84
No
Yes
No
No
No
No
No
No
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
CLOVER PHARMACEUTICALS CORP
HOSPIRA INC
SUN PHARMA GLOBAL INC
ABBOTT LABORATORIES
ASTRAZENECA LP
ASTRAZENECA LP
EMCURE PHARMACEUTICALS LTD
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
ABRAXIS PHARMACEUTICAL PRODUCTS
BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE
HOSPIRA INC
HOSPIRA INC
MERCK AND CO INC
GD SEARLE LLC
GD SEARLE LLC
HOSPIRA INC
HOSPIRA INC
INTERNATIONAL MEDICATION SYSTEM
INTERNATIONAL MEDICATION SYSTEMS LTD
LYPHOMED DIV FUJISAWA USA INC
PHARMA SERVE INC SUB TORIGIAN LABORATORIES
PHARMA SERVE INC SUB TORIGIAN LABORATORIES
SMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
ABBVIE INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
No
No
RX
HOSPIRA INC
DISCN HOSPIRA INC
15‐May‐84 No
Page 00174
Ingredient
AMINO ACIDS; DEXTROSE
AMINO ACIDS
AMINO ACIDS
AMINO ACIDS
DF;Route
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
AMINO ACIDS
AMINO ACIDS
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
AMINO ACIDS
AMINO ACIDS
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
AMINO ACIDS
AMINO ACIDS
AMINO ACIDS
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
AMINO ACIDS
AMINO ACIDS
AMINO ACIDS
AMINO ACIDS
AMINO ACIDS
AMINO ACIDS
AMINO ACIDS
AMINO ACIDS
AMINO ACIDS
AMIODARONE HYDROCHLORIDE
Page 00175
Trade_Name
Applicant
Strength
AMINOSYN 3.5% M IN PLASTIC CONTAINER
AMINOSYN 3.5% W/ DEXTROSE 25% IN PLASTIC CONTAINER
AMINOSYN 5%
AMINOSYN 7%
AMINOSYN 7% (PH6)
ABBOTT
ABBOTT
ABBOTT
ABBOTT
HOSPIRA
HOSPIRA
HOSPIRA
3.5%;25GM/100ML
3.5%;5GM/100ML
4.25%;25GM/100ML
5% (5GM/100ML)
7% (7GM/100ML)
7% (7GM/100ML)
AMINOSYN 7% W/ ELECTROLYTES
AMINOSYN 8.5%
AMINOSYN 8.5% (PH6)
HOSPIRA
HOSPIRA
HOSPIRA
7%;102MG/100ML;522MG/100ML;410MG/100ML
8.5% (8.5GM/100ML)
8.5% (8.5GM/100ML)
AMINOSYN 8.5% W/ ELECTROLYTES
AMINOSYN II 10%
AMINOSYN II 10% IN PLASTIC CONTAINER
HOSPIRA
HOSPIRA
HOSPIRA
8.5%;102MG/100ML;522MG/100ML;410MG/100ML
10% (10GM/100ML)
10% (10GM/100ML)
AMINOSYN II 10% W/ ELECTROLYTES
AMINOSYN II 15% IN PLASTIC CONTAINER
AMINOSYN II 3.5%
AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER
AMINOSYN II 3.5% IN PLASTIC CONTAINER
HOSPIRA
HOSPIRA
HOSPIRA
ABBOTT
ABBOTT
HOSPIRA
ABBOTT
ABBOTT
HOSPIRA
ABBOTT
10%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML
15% (15GM/100ML)
3.5% (3.5GM/100ML)
3.5%;25GM/100ML
3.5%;25GM/100ML
3.5%;25GM/100ML
3.5%;5GM/100ML
3.5%;5GM/100ML
3.5%;5GM/100ML
3.5% (3.5GM/100ML)
AMINOSYN II 3.5% M
HOSPIRA
AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER
ABBOTT
3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML
ABBOTT
HOSPIRA INC
AMINOSYN II 3.5% M IN PLASTIC CONTAINER
ABBOTT
AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER
ABBOTT
3.5%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML
AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
ABBOTT
3.5%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML
HOSPIRA INC
ABBOTT
HOSPIRA
ABBOTT
HOSPIRA
ABBOTT
ABBOTT
HOSPIRA
4.25%;10GM/100ML
4.25%;10GM/100ML
4.25%;20GM/100ML
4.25%;20GM/100ML
4.25%;25GM/100ML
4.25%;25GM/100ML
4.25%;25GM/100ML
ABBOTT
HOSPIRA INC
AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER HOSPIRA INC
4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100
ML
4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100
ML
ABBOTT
HOSPIRA INC
AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER ABBOTT
AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER
ABBOTT
4.25%;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML
ABBOTT
AMINOSYN II 5%
AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER
HOSPIRA INC
HOSPIRA
ABBOTT
ABBOTT
HOSPIRA
5% (5GM/100ML)
5%;25GM/100ML
5%;25GM/100ML
5%;25GM/100ML
AMINOSYN II 5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
ABBOTT
5%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML
AMINOSYN II 5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
AMINOSYN II 7%
HOSPIRA INC
HOSPIRA
5%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML
7% (7GM/100ML)
AMINOSYN II 7% W/ ELECTROLYTES
AMINOSYN II 8.5%
HOSPIRA
HOSPIRA
7%;102MG/100ML;45MG/100ML;522MG/100ML;410MG/100ML
8.5% (8.5GM/100ML)
AMINOSYN II 8.5% W/ ELECTROLYTES
AMINOSYN‐HBC 7%
AMINOSYN‐HBC 7% IN PLASTIC CONTAINER
AMINOSYN‐HF 8%
AMINOSYN‐PF 10%
AMINOSYN‐PF 7%
AMINOSYN‐RF 5.2%
HOSPIRA
HOSPIRA
ABBOTT
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
AKORN
BEDFORD
BEDFORD LABS
BEN VENUE
FRESENIUS KABI USA
GLAND PHARMA LTD
HIKMA FARMACEUTICA
HOSPIRA
HOSPIRA
HOSPIRA INC
HOSPIRA INC
INTL MEDICATION SYS
7% (7GM/100ML)
7% (7GM/100ML)
8% (8GM/100ML)
10% (10GM/100ML)
7% (7GM/100ML)
5.2% (5.2GM/100ML)
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
Page 00176
Appl_Type
Approval_Date
RLD Type
Applicant_Full_Name
No
No
No
No
No
No
No
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
N
N
N
N
N
N
N
18875
19118
19120
19119
17673
17673
17673
2
1
1
1
1
2
6
8‐Aug‐84
11‐Oct‐84
11‐Oct‐84
11‐Oct‐84
18‐Nov‐85
N
N
N
17789
17673
17673
2
4
7
No
No
18‐Nov‐85 No
RX
RX
RX
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
N
N
N
17673
19438
20015
5
5
1
No
3‐Apr‐86 No
19‐Dec‐91 No
RX
RX
RX
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
N
N
N
N
N
N
N
N
N
N
19437
20041
19438
19505
19713
19681
19506
19713
19681
19491
4
1
1
2
6
1
1
2
2
1
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
N
19437
7
3‐Apr‐86 No
N
19564
1
16‐Dec‐86 No
3‐Apr‐86
19‐Dec‐91
3‐Apr‐86
7‐Nov‐86
9‐Sep‐88
1‐Nov‐88
7‐Nov‐86
9‐Sep‐88
1‐Nov‐88
10‐Oct‐86
No
No
No
No
No
No
No
No
No
No
DISCN HOSPIRA INC
N
19712
1
8‐Sep‐88 No
DISCN ABBOTT LABORATORIES HOSP PRODUCTS DIV
N
19682
1
1‐Nov‐88 No
DISCN HOSPIRA INC
N
19493
1
16‐Oct‐86 No
N
19564
2
16‐Dec‐86 No
N
19714
1
12‐Sep‐88 No
N
N
N
N
N
N
N
N
19683
19713
19681
19713
19681
19504
19713
19681
1
1
4
4
5
2
5
3
7‐Nov‐88
9‐Sep‐88
1‐Nov‐88
9‐Sep‐88
1‐Nov‐88
7‐Nov‐86
9‐Sep‐88
1‐Nov‐88
No
No
No
No
No
No
No
No
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
HOSPIRA INC
N
19564
3
16‐Dec‐86 No
N
19682
2
1‐Nov‐88 No
DISCN HOSPIRA INC
N
19712
2
8‐Sep‐88 No
N
19682
3
1‐Nov‐88 No
N
19714
2
12‐Sep‐88 No
N
19683
2
7‐Nov‐88 No
DISCN HOSPIRA INC
DISCN HOSPIRA INC
N
19564
4
16‐Dec‐86 No
N
19714
4
12‐Sep‐88 No
N
N
N
N
N
19683
19438
19565
19713
19681
3
2
1
3
6
7‐Nov‐88
3‐Apr‐86
17‐Dec‐86
9‐Sep‐88
1‐Nov‐88
DISCN
DISCN
DISCN
DISCN
DISCN
No
No
No
No
No
HOSPIRA INC
HOSPIRA INC
N
19714
3
12‐Sep‐88 No
N
N
19683
19438
4
3
7‐Nov‐88 No
3‐Apr‐86 No
DISCN HOSPIRA INC
RX
HOSPIRA INC
N
N
19437
19438
6
4
3‐Apr‐86 No
3‐Apr‐86 No
DISCN HOSPIRA INC
RX
HOSPIRA INC
N
N
N
A
N
N
N
A
A
A
A
A
A
A
A
A
A
A
N
19437
19374
19400
20345
19492
19398
18429
76232
76018
76299
76088
75761
77161
77234
75955
76108
203884
203885
21594
5
1
1
1
2
1
1
1
1
1
1
1
1
1
1
1
1
1
1
AP
AP
AP
AP
AP
AP
AP
3‐Apr‐86
12‐Jul‐85
23‐Jul‐86
4‐Apr‐96
17‐Oct‐86
6‐Sep‐85
5‐Jul‐06
15‐Oct‐02
24‐Oct‐02
15‐Oct‐02
15‐Oct‐02
20‐Apr‐05
25‐Feb‐08
18‐Oct‐02
15‐Oct‐02
25‐Nov‐13
25‐Nov‐13
4‐Feb‐04
No
No
No
No
No
No
No
Yes
No
No
No
Yes
Yes
No
Yes
No
No
No
No
RX
RX
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
RX
RX
DISCN
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
AKORN INC
BEDFORD LABORATORIES
BEN VENUE LABORATORIES INC
GLAND PHARMA LTD
HIKMA FARMACEUTICA (PORTUGAL) SA
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
Page 00177
Ingredient
METRIZAMIDE
METRIZAMIDE
METRIZAMIDE
METRIZAMIDE
AMMONIUM CHLORIDE
AMMONIUM CHLORIDE
AMMONIUM CHLORIDE
AMMONIUM CHLORIDE
AMMONIUM CHLORIDE
HYALURONIDASE
AMPHOTERICIN B
AMPHOTERICIN B
AMPHOTERICIN B
AMPHOTERICIN B
AMPICILLIN SODIUM; SULBACTAM SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
DF;Route
Page 00178
Trade_Name
AMIPAQUE
AMIPAQUE
AMIPAQUE
AMIPAQUE
AMMONIUM CHLORIDE
AMMONIUM CHLORIDE
AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE
AMMONIUM CHLORIDE 2.14%
AMMONIUM CHLORIDE IN PLASTIC CONTAINER
AMPHADASE
AMPHOTERICIN B
AMPHOTERICIN B
AMPHOTERICIN B
AMPHOTERICIN B
AMPICILLIN AND SULBACTAM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
Applicant
MYLAN INSTITUTIONAL
TEVA PHARMS USA
WOCKHARDT
WOCKHARDT
GE HEALTHCARE
GE HEALTHCARE
GE HEALTHCARE
GE HEALTHCARE
WATSON LABS
ABBOTT
GD SEARLE LLC
MCGAW
B BRAUN
HOSPIRA
AMPHASTAR PHARM
ABBOTT
ABRAXIS PHARM
TEVA PARENTERAL
X GEN PHARMS
ACS DOBFAR
ACS DOBFAR
ACS DOBFAR
AGILA SPECLTS
AGILA SPECLTS
AGILA SPECLTS
AUROBINDO PHARMA
AUROBINDO PHARMA
AUROBINDO PHARMA
AUROBINDO PHARMA
AUROBINDO PHARMA
HANFORD GC
HANFORD GC
HANFORD GC
HIKMA MAPLE HIKMA MAPLE HIKMA MAPLE HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
ISTITUTO BIO ITA SPA
MUSTAFA NEVZAT ILAC
MUSTAFA NEVZAT ILAC
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
ACS DOBFAR SPA
ACS DOBFAR SPA
ACS DOBFAR SPA
ACS DOBFAR SPA
AGILA SPECLTS
ANTIBIOTICE
ANTIBIOTICE
ANTIBIOTICE
ANTIBIOTICE
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
AUROBINDO PHARMA
AUROBINDO PHARMA
AUROBINDO PHARMA
AUROBINDO PHARMA
AUROBINDO PHARMA
AUROBINDO PHARMA
CONSOLIDATED PHARM
CONSOLIDATED PHARM
CONSOLIDATED PHARM
CONSOLIDATED PHARM
CONSOLIDATED PHARM
HANFORD GC
HANFORD GC
HANFORD GC
HANFORD GC
HANFORD GC
HANFORD GC
HANFORD GC
HANFORD GC
HANFORD GC
HIKMA MAPLE HIKMA MAPLE HIKMA MAPLE HIKMA MAPLE HIKMA MAPLE HIKMA MAPLE INTL MEDICATION
INTL MEDICATION
Strength
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
2.5GM/VIAL
3.75GM/VIAL
6.75GM/VIAL
13.5GM/VIAL
10MG/ML
5MEQ/ML
3MEQ/ML
900MG/100ML
40MEQ/100ML
5MEQ/ML
150 UNITS/ML
50MG/VIAL
50MG/VIAL
50MG/VIAL
50MG/VIAL
EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL
EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 10GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 125MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 125MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 125MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 125MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 125MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 125MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
Page 00179
Appl_Type
A
A
A
A
A
N
N
N
N
A
A
A
N
A
A
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
76217
1 AP
76394
1
76163
1
77610
1 AP
77834
1 AP
17982
3
17982
1
17982
2
17982
4
85594
1
83130
1
86205
1
6580
1
85734
1
88366
1
21665
1
64141
1
62728
1
64062
1
63206
1
65406
1 AP
65406
2 AP
65403
1 AP
201024
1 AP
201024
2 AP
202197
1 AP
90340
1 AP
90349
1 AP
90340
2 AP
90349
2 AP
90339
1 AP
65176
1 AP
65176
2 AP
65188
1 AP
65074
1 AP
65074
2 AP
65076
1 AP
90375
1 AP
90653
1 AP
90375
2 AP
90653
2 AP
90646
1 AP
65222
1 AP
65222
2 AP
65314
1 AP
65316
1 AP
65316
2 AP
65241
1 AP
65310
1 AP
65241
2 AP
65310
2 AP
65240
1 AP
90884
2 AP
90884
3 AP
90889
1 AP
90884
1 AP
202198
1 AP
90354
3 AP
90354
4 AP
90354
1 AP
90354
2 AP
62860
4
62860
5
62860
1
62860
2
62860
3
65499
4 AP
65499
5 AP
65493
1 AP
65499
1 AP
65499
2 AP
65499
3 AP
61936
3
61936
4
61936
5
61936
1
61936
2
62772
1 AP
63139
1
63140
1 AP
63141
1
63142
1 AP
63143
1
63145
1 AP
63146
1 AP
63147
1
62692
4
62692
5
62692
6
62692
1
62692
2
62692
3
62634
2
62634
3
62719
2 AP
62797
2 AP
201404
1 AP
62797
1 AP
62719
1 AP
62719
3 AP
Approval_Date
15‐Oct‐02
25‐Apr‐03
5‐Sep‐03
30‐Oct‐08
30‐Oct‐08
12‐Sep‐83
12‐Sep‐83
13‐Jun‐84
26‐Oct‐04
23‐Dec‐96
13‐Apr‐87
31‐Mar‐95
29‐Apr‐92
22‐Dec‐09
22‐Dec‐09
23‐Dec‐09
7‐Apr‐14
7‐Apr‐14
7‐Apr‐14
20‐Sep‐10
20‐Sep‐10
20‐Sep‐10
20‐Sep‐10
20‐Sep‐10
30‐Nov‐05
30‐Nov‐05
25‐Nov‐05
19‐Mar‐02
19‐Mar‐02
19‐Mar‐02
21‐Dec‐11
21‐Dec‐11
21‐Dec‐11
21‐Dec‐11
21‐Dec‐11
29‐Nov‐05
29‐Nov‐05
27‐Nov‐06
29‐Jun‐07
29‐Jun‐07
25‐Jul‐06
25‐Jul‐06
25‐Jul‐06
25‐Jul‐06
25‐Jul‐06
3‐Apr‐13
3‐Apr‐13
3‐Apr‐13
3‐Apr‐13
7‐Apr‐14
28‐Dec‐09
28‐Dec‐09
28‐Dec‐09
28‐Dec‐09
5‐Feb‐88
5‐Feb‐88
5‐Feb‐88
5‐Feb‐88
5‐Feb‐88
17‐Aug‐10
17‐Aug‐10
17‐Aug‐10
17‐Aug‐10
17‐Aug‐10
17‐Aug‐10
15‐Apr‐93
15‐Apr‐93
15‐Apr‐93
15‐Apr‐93
15‐Apr‐93
15‐Apr‐93
15‐Apr‐93
15‐Apr‐93
15‐Apr‐93
24‐Jun‐86
24‐Jun‐86
24‐Jun‐86
24‐Jun‐86
24‐Jun‐86
24‐Jun‐86
9‐Jan‐87
9‐Jan‐87
12‐May‐87
12‐Jul‐93
20‐Dec‐13
12‐Jul‐93
12‐May‐87
12‐May‐87
RLD
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Type
RX
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
DISCN
RX
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
Applicant_Full_Name
WOCKHARDT LTD
WOCKHARDT LTD
GE HEALTHCARE
GE HEALTHCARE
GE HEALTHCARE
GE HEALTHCARE
GD SEARLE LLC
MCGAW INC
B BRAUN MEDICAL INC
HOSPIRA INC
AMPHASTAR PHARMACEUTICAL INC
ABBOTT LABORATORIES
ACS DOBFAR SPA
ACS DOBFAR SPA
ACS DOBFAR SPA
AUROBINDO PHARMA
AUROBINDO PHARMA
AUROBINDO PHARMA
AUROBINDO PHARMA
AUROBINDO PHARMA
GC HANFORD MANUFACTURING CO
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
ISTITUTO BIOCHIMICO ITALIANO SPA
MUSTAFA NEVZAT ILAC SANAYII AS (MN PHARMACEUTICALS)
MUSTAFA NEVZAT ILAC SANAYII AS (MN PHARMACEUTICALS)
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
ACS DOBFAR SPA
ACS DOBFAR SPA
ACS DOBFAR SPA
ACS DOBFAR SPA
ANTIBIOTICE SA
ANTIBIOTICE SA
ANTIBIOTICE SA
ANTIBIOTICE SA
CONSOLIDATED PHARMACEUTICAL GROUP INC
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HIKMA MAPLE LTD
Page 00180
Ingredient
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
INAMRINONE LACTATE
INAMRINONE LACTATE
INAMRINONE LACTATE
TECHNETIUM TC‐99M PENTETATE KIT
TECHNETIUM TC‐99M ALBUMIN AGGREGATED KIT
CEFAZOLIN SODIUM
DF;Route
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
SUCCINYLCHOLINE CHLORIDE
IOTHALAMATE SODIUM
DIATRIZOATE MEGLUMINE
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
PENTOLINIUM TARTRATE
FOMEPIZOLE
DOLASETRON MESYLATE
DOLASETRON MESYLATE
DOLASETRON MESYLATE
GENTAMICIN SULFATE
GENTAMICIN SULFATE
HYDRALAZINE HYDROCHLORIDE
PHYTONADIONE
PHYTONADIONE
VITAMIN A PALMITATE
CHLOROQUINE HYDROCHLORIDE
METARAMINOL BITARTRATE
PIPECURONIUM BROMIDE
PAMIDRONATE DISODIUM
MEPIVACAINE HYDROCHLORIDE
LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE
TRIMETHAPHAN CAMSYLATE
ARGATROBAN
ARGATROBAN
ARGATROBAN
TRIAMCINOLONE DIACETATE
TRIAMCINOLONE DIACETATE
TRIAMCINOLONE HEXACETONIDE
TRIAMCINOLONE HEXACETONIDE
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
SOMATROPIN
SOMATROPIN
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
MORPHINE SULFATE
LORAZEPAM
LORAZEPAM
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
Page 00181
Trade_Name
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMPICILLIN SODIUM
AMRINONE LACTATE
AMRINONE LACTATE
AMRINONE LACTATE
AN‐DTPA
AN‐MAA
ANCEF
Applicant
LILLY
LILLY
LILLY
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
SANDOZ
STRIDES ARCOLAB LTD
STRIDES ARCOLAB LTD
STRIDES ARCOLAB LTD
STRIDES ARCOLAB LTD
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
BAXTER HLTHCARE CORP
EUROHLTH INTL
HOSPIRA
JUBILANT DRAXIMAGE
PHARMALUCENCE
GLAXOSMITHKLINE
ANCEF
ANCEF
GLAXOSMITHKLINE
GLAXOSMITHKLINE
ANCEF
ANCEF
ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER
ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER
ANCEF IN PLASTIC CONTAINER
ANCEF IN PLASTIC CONTAINER
ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANECTINE
ANECTINE
ANECTINE
ANECTINE
ANGIO‐CONRAY
ANGIOVIST 282
ANGIOVIST 292
ANGIOVIST 370
ANSOLYSEN
ANTIZOL
ANZEMET
ANZEMET
ANZEMET
APOGEN
APOGEN
APRESOLINE
AQUAMEPHYTON
AQUAMEPHYTON
AQUASOL A
ARALEN HYDROCHLORIDE
ARAMINE
ARDUAN
AREDIA
AREDIA
AREDIA
ARESTOCAINE HYDROCHLORIDE
ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN
ARFONAD
ARGATROBAN
ARGATROBAN
ARGATROBAN
ARISTOCORT
GLAXOSMITHKLINE
GLAXOSMITHKLINE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
SANDOZ
SANDOZ
SANDOZ
SANDOZ
MALLINCKRODT
BAYER HLTHCARE
BAYER HLTHCARE
BAYER HLTHCARE
WYETH AYERST
PALADIN LABS
SANOFI AVENTIS US
SANOFI AVENTIS US
SANOFI AVENTIS US
KING PHARMS
KING PHARMS
NOVARTIS
BIOVAIL TECHNOLOGIES
BIOVAIL TECHNOLOGIES
HOSPIRA
SANOFI AVENTIS US
MERCK
ORGANON USA INC
NOVARTIS
NOVARTIS
NOVARTIS
SOLVAY
SOLVAY
ROCHE
HIKMA PHARM CO LTD
MYLAN INSTITUTIONAL
SANDOZ
ARISTOCORT
ARISTOSPAN
ARISTOSPAN
ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
ASELLACRIN 10
ASELLACRIN 2
ASTRAMORPH PF
ASTRAMORPH PF
ASTRAMORPH PF
ASTRAMORPH PF
ATIVAN
ATIVAN
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE
ATRACURIUM BESYLATE PRESERVATIVE FREE
SANDOZ
SANDOZ
SANDOZ
HOSPIRA
SERONO
SERONO
FRESENIUS KABI USA
FRESENIUS KABI USA
FRESENIUS KABI USA
FRESENIUS KABI USA
HIKMA MAPLE HIKMA MAPLE BAXTER HLTHCARE
EUROHLTH INTL
HOSPIRA
HOSPIRA
HOSPIRA INC
SAGENT PHARMS
TEVA PARENTERAL
WATSON LABS INC
BAXTER HLTHCARE
EUROHLTH INTL
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA INC
SAGENT PHARMS
WATSON LABS INC
Strength
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 125MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 125MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 5MG BASE/ML
EQ 5MG BASE/ML
EQ 5MG BASE/ML
N/A
N/A
EQ 1GM BASE/VIAL
EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
EQ 10GM BASE/VIAL
EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
EQ 500MG BASE/VIAL
EQ 10MG BASE/ML
EQ 20MG BASE/ML
EQ 10MG BASE/ML
EQ 20MG BASE/ML
EQ 10MG BASE/ML
EQ 20MG BASE/ML
1GM/VIAL
20MG/ML
50MG/ML
500MG/VIAL
80%
60%
52%;8%
66%;10%
10MG/ML
1.5GM/1.5ML (1GM/ML)
12.5MG/0.625ML (20MG/ML)
100MG/5ML (20MG/ML)
500MG/25ML (20MG/ML)
EQ 10MG BASE/ML
EQ 40MG BASE/ML
20MG/ML
1MG/0.5ML
10MG/ML
EQ 50,000 UNITS BASE/ML
EQ 40MG BASE/ML
EQ 10MG BASE/ML
10MG/VIAL
30MG/VIAL
60MG/VIAL
90MG/VIAL
3%
0.05MG/ML;2%
50MG/ML
250MG/2.5ML (100MG/ML)
250MG/2.5ML (100MG/ML)
250MG/2.5ML (100MG/ML)
25MG/ML
5MG/ML
20MG/ML
4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)
10 IU/VIAL
2 IU/VIAL
0.5MG/ML
0.5MG/ML
1MG/ML
1MG/ML
2MG/ML
4MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
10MG/ML
Page 00182
Appl_Type
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
62565
2
62565
3
62565
1
61395
4 AP
61395
5 AP
61395
6 AP
61395
1 AP
61395
2 AP
61395
3 AP
201025
3 AP
201025
4 AP
201025
1 AP
201025
2 AP
62816
4
62816
5
62994
1
62816
1
62816
2
62816
3
75542
1
75513
1
74616
1
17714
1 AP
17792
1
50461
3
Approval_Date
4‐Apr‐85
24‐Jun‐86
4‐Apr‐85
9‐Apr‐14
9‐Apr‐14
9‐Apr‐14
9‐Apr‐14
24‐Oct‐88
24‐Oct‐88
15‐Sep‐88
24‐Oct‐88
24‐Oct‐88
24‐Oct‐88
10‐May‐00
9‐May‐00
3‐Aug‐98
RLD
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
Type
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
DISCN
DISCN
Applicant_Full_Name
ELI LILLY AND CO
ELI LILLY AND CO
ELI LILLY AND CO
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
STRIDES ARCOLAB LTD
STRIDES ARCOLAB LTD
STRIDES ARCOLAB LTD
STRIDES ARCOLAB LTD
BAXTER HEALTHCARE CORP ANESTHESIA CRITICAL CARE
HOSPIRA INC
PHARMALUCENCE INC
GLAXOSMITHKLINE
N
N
50461
50461
4
5
No
No
N
N
N
N
A
A
N
N
N
N
N
N
N
A
A
A
N
N
N
N
N
A
A
N
N
N
N
N
N
N
N
N
N
A
A
N
N
A
A
N
50461
50461
50566
50566
63002
63002
50566
50566
8453
8453
8453
8453
13319
87726
87724
87723
9372
20696
20624
20624
20624
62289
62289
8303
12223
12223
6823
6002
9509
19638
20036
20036
20036
84777
85010
8983
203049
202626
91665
11685
1
2
3
4
1
2
1
2
4
2
3
1
1
1
1
1
1
1
2
1
3
1
2
3
2
1
1
2
2
1
1
3
4
2
1
1
1
1
1
3
8‐Jun‐83
8‐Jun‐83
28‐Mar‐91
28‐Mar‐91
8‐Jun‐83
8‐Jun‐83
23‐Sep‐82
23‐Sep‐82
23‐Sep‐82
4‐Dec‐97
11‐Sep‐97
11‐Sep‐97
11‐Dec‐01
22‐Dec‐87
26‐Jun‐90
31‐Oct‐91
6‐May‐93
6‐May‐93
18‐Apr‐82
5‐Jan‐12
30‐Jun‐14
30‐Jun‐14
No
No
No
No
Yes
Yes
No
No
No
Yes
No
No
No
No
No
No
No
Yes
Yes
Yes
Yes
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
GLAXOSMITHKLINE
GLAXOSMITHKLINE
SANDOZ CANADA INC
SANDOZ CANADA INC
SANDOZ CANADA INC
SANDOZ CANADA INC
PALADIN LABS USA INC
BIOVAIL TECHNOLOGIES LTD
BIOVAIL TECHNOLOGIES LTD
HOSPIRA INC
MERCK AND CO INC
ORGANON USA INC
HIKMA PHARM CO LTD
SANDOZ CANADA INC
N
N
N
A
N
N
A
A
A
A
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
12802
16466
16466
79138
17726
17726
71050
71051
71052
71053
18140
18140
74824
74753
74901
74632
74740
90761
91489
74784
74945
74825
74768
74900
74633
74639
74741
90782
91488
74944
1
1
2
1
1
2
1
1
1
1
1
2
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
18‐Jun‐10
21‐Jul‐83
7‐Oct‐86
7‐Oct‐86
7‐Oct‐86
7‐Oct‐86
30‐Sep‐97
23‐Jan‐97
18‐Jul‐97
23‐Dec‐96
28‐Mar‐97
18‐Oct‐12
17‐Feb‐12
11‐Jun‐97
28‐Jul‐98
30‐Sep‐97
23‐Jan‐97
18‐Jul‐97
23‐Dec‐96
25‐Mar‐97
28‐Mar‐97
18‐Oct‐12
17‐Feb‐12
28‐Jul‐98
No
Yes
Yes
No
No
No
No
No
No
No
Yes
Yes
No
No
Yes
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
DISCN
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
RX
RX
DISCN
SANDOZ CANADA INC
SANDOZ CANADA INC
SANDOZ CANADA INC
HOSPIRA INC
SERONO LABORATORIES INC
SERONO LABORATORIES INC
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
SAGENT PHARMACEUTICALS INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
Page 00183
Ingredient
ATROPINE
ATROPINE
ATROPINE
ATROPINE
ATROPINE
ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE
AZTREONAM
AZTREONAM
AZTREONAM
AZTREONAM
AZTREONAM
AZTREONAM
AZATHIOPRINE SODIUM
AZITHROMYCIN
AZITHROMYCIN
AZITHROMYCIN
AZITHROMYCIN
AZITHROMYCIN
AZITHROMYCIN
AZITHROMYCIN
AZITHROMYCIN
AZITHROMYCIN
AZLOCILLIN SODIUM
AZLOCILLIN SODIUM
AZLOCILLIN SODIUM
AZLOCILLIN SODIUM
AZLOCILLIN SODIUM
AZLOCILLIN SODIUM
AZLOCILLIN SODIUM
AZLOCILLIN SODIUM
AZLOCILLIN SODIUM
AZTREONAM
AZTREONAM
AZTREONAM
AZTREONAM
AZTREONAM
BACITRACIN
BACITRACIN
BACITRACIN
BACITRACIN
BACITRACIN
BACITRACIN
BACITRACIN
SODIUM CHLORIDE
SODIUM CHLORIDE
SODIUM CHLORIDE
OXACILLIN SODIUM
OXACILLIN SODIUM
OXACILLIN SODIUM
OXACILLIN SODIUM
OXACILLIN SODIUM
OXACILLIN SODIUM
OXACILLIN SODIUM
OXACILLIN SODIUM
OXACILLIN SODIUM
SULFAMETHOXAZOLE; TRIMETHOPRIM
DIMERCAPROL
BENZTROPINE MESYLATE
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'‐PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN E
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
THIAMINE HYDROCHLORIDE
BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE
BETAMETHASONE SODIUM PHOSPHATE
PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE
PENICILLIN G BENZATHINE
CARMUSTINE
SOMATROPIN RECOMBINANT
BLEOMYCIN SULFATE
BLEOMYCIN SULFATE
BLEOMYCIN SULFATE
BLEOMYCIN SULFATE
BLEOMYCIN SULFATE
BLEOMYCIN SULFATE
BLEOMYCIN SULFATE
BLEOMYCIN SULFATE
BLEOMYCIN SULFATE
BLEOMYCIN SULFATE
BLEOMYCIN SULFATE
BLEOMYCIN SULFATE
BLEOMYCIN SULFATE
AMINO ACIDS
AMINO ACIDS
DF;Route
Page 00184
Trade_Name
ATROPEN
ATROPEN
ATROPEN
ATROPEN
ATROPINE
ATROPINE AND DEMEROL
AZACTAM
AZACTAM
AZACTAM
AZACTAM IN PLASTIC CONTAINER
AZATHIOPRINE SODIUM
AZITHROMYCIN
AZITHROMYCIN
AZITHROMYCIN
AZITHROMYCIN
AZITHROMYCIN
AZITHROMYCIN
AZITHROMYCIN
AZITHROMYCIN
AZITHROMYCIN
AZLIN
AZLIN
AZLIN
AZLIN
AZLIN
AZLIN
AZLIN
AZLIN
AZLIN
AZTREONAM
AZTREONAM
AZTREONAM
AZTREONAM
AZTREONAM
BACIIM
BACITRACIN
BACITRACIN
BACITRACIN
BACITRACIN
BACITRACIN
BACITRACIN
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BACTOCILL
BACTOCILL
BACTOCILL
BACTOCILL
BACTOCILL
BACTOCILL
BACTOCILL
BACTOCILL IN PLASTIC CONTAINER
BACTOCILL IN PLASTIC CONTAINER
BACTRIM
BAL
BENADRYL
BENADRYL
BENADRYL PRESERVATIVE FREE
BENTYL
BENTYL PRESERVATIVE FREE
Applicant
MERIDIAN MEDCL TECHN
ABBVIE
ABBVIE
ABBVIE
ABBVIE
EUROHLTH INTL
FRESENIUS KABI USA
GLAND PHARMA LTD
HOSPIRA
HOSPIRA
PLIVA HRVATSKA DOO
SAGENT STRIDES
SUN PHARM INDS LTD
TEVA PARENTERAL
TEVA PARENTERAL
BAYER PHARMS
BAYER PHARMS
BAYER PHARMS
BAYER PHARMS
BAYER PHARMS
BAYER PHARMS
BAYER PHARMS
BAYER PHARMS
BAYER PHARMS
EUROHLTH INTL
EUROHLTH INTL
FRESENIUS KABI USA
FRESENIUS KABI USA
FRESENIUS KABI USA
X GEN PHARMS
FRESENIUS KABI USA
PFIZER
SAGENT STRIDES
XELLIA PHARMS APS
ABRAXIS PHARM
FRESENIUS KABI USA
HOSPIRA
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
BAXTER HLTHCARE
BAXTER HLTHCARE
MUTUAL PHARM
AKORN
MCNEIL CONS
MCNEIL CONS
MCNEIL CONS
FOREST LABS INC
FOREST LABS INC
FRESENIUS KABI USA
HIKMA FARMACEUTICA
LUITPOLD
NAVINTA LLC
Strength
EQ 0.25MG SULFATE/0.3ML
EQ 0.5MG SULFATE/0.7ML
EQ 1MG SULFATE/0.7ML
0.4MG/ML;50MG/ML
0.4MG/ML;75MG/ML
0.4MG/ML;100MG/ML
1GM/VIAL
2GM/VIAL
500MG/VIAL
10MG/ML
20MG/ML
40MG/ML
EQ 100MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 2.5GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 3GM BASE/VIAL
EQ 3GM BASE/VIAL
EQ 3GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 4GM BASE/VIAL
1GM/VIAL
2GM/VIAL
1GM/VIAL
2GM/VIAL
500MG/VIAL
50,000 UNITS/VIAL
50,000 UNITS/VIAL
50,000 UNITS/VIAL
10,000 UNITS/VIAL
50,000 UNITS/VIAL
50,000 UNITS/VIAL
50,000 UNITS/VIAL
9MG/ML
9MG/ML
9MG/ML
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 20MG BASE/ML
EQ 40MG BASE/ML
80MG/ML;16MG/ML
10MG/ML
50MG/ML
50MG/ML
10MG/ML
10MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
BEROCCA PN
BERUBIGEN
BETALIN 12
BETALIN 12
BETALIN S
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
BICILLIN C‐R
BICILLIN C‐R
BICILLIN C‐R 900/300
BICILLIN L‐A
BICILLIN L‐A
BICILLIN L‐A
BICNU
BIO‐TROPIN
BLENOXANE
BLENOXANE
BLEOMYCIN SULFATE
BLEOMYCIN SULFATE
BLEOMYCIN SULFATE
BLEOMYCIN SULFATE
BLEOMYCIN SULFATE
BLEOMYCIN SULFATE
BLEOMYCIN SULFATE
BLEOMYCIN SULFATE
BLEOMYCIN SULFATE
BLEOMYCIN SULFATE
BLEOMYCIN SULFATE
BRANCHAMIN 4%
BRANCHAMIN 4% IN PLASTIC CONTAINER
ROCHE
LILLY
LILLY
LILLY
LUITPOLD
WATSON LABS
KING PHARMS
KING PHARMS
KING PHARMS
KING PHARMS
KING PHARMS
WYETH AYERST
EMCURE PHARMS LTD
FERRING
EUROHLTH INTL
EUROHLTH INTL
FRESENIUS KABI USA
FRESENIUS KABI USA
HOSPIRA
HOSPIRA
PHARMACHEMIE BV
TEVA PARENTERAL
TEVA PARENTERAL
TEVA PHARMS USA
TEVA PHARMS USA
BAXTER HLTHCARE
BAXTER HLTHCARE
50MG/ML;0.03MG/ML;0.0025MG/ML;7.5MG/ML;100 IU/ML;0.2MG/ML;20MG/ML;2MG/ML;1.8MG/ML;1.5MG/ML;1,650 IU/ML;5 IU/ML
1MG/ML
0.1MG/ML
1MG/ML
100MG/ML
3MG/ML;EQ 3MG BASE/ML
EQ 3MG BASE/ML
150,000 UNITS/ML;150,000 UNITS/ML
300,000 UNITS/ML;300,000 UNITS/ML
900,000 UNITS/2ML;300,000 UNITS/2ML
300,000 UNITS/ML
600,000 UNITS/ML
300,000 UNITS/ML
100MG/VIAL
4.8MG/VIAL
EQ 15 UNITS BASE/VIAL
4% (4GM/100ML)
4% (4GM/100ML)
10%
Page 00185
Appl_Type
N
N
N
N
A
A
A
A
N
N
N
N
N
N
A
A
A
A
A
A
A
A
N
N
A
A
N
A
A
N
A
A
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
A
A
A
A
A
A
A
N
N
N
N
N
N
N
N
N
A
A
A
A
N
N
A
A
A
A
A
N
N
N
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
N
N
17106
4
17106
3
17106
2
17106
1
71295
1
87853
1
87847
1
87848
1
50580
2 AP
50580
3 AP
50580
1
50632
3
50632
2
50632
1
74419
1
65179
1 AP
65501
1 AP
65500
1 AP
65511
1 AP
65265
1
65506
1 AP
90923
1 AP
50809
2
50809
1
62388
1
62417
1
50562
1
62388
2
62417
2
50562
2
62388
3
62417
3
50562
3
65286
1 AP
65286
2 AP
65439
2 AP
65439
3 AP
65439
1
64153
1 AP
65116
1 AP
60282
1
60733
1
60733
2 AP
90211
1 AP
203177
1 AP
88909
1
88911
1 AP
18800
1 AP
61334
6
62736
1
61334
7
62736
2
61334
8
61334
10
61334
9
50640
1
50640
2
18374
1
5939
1
6146
1
6146
2
9486
1
8370
1 AP
8370
2 AP
90233
1 AP
90287
1 AP
91152
1 AP
91525
1 AP
6071
6798
80855
80855
80853
90747
85738
50138
50138
50138
50141
50141
50131
17422
19774
50443
50443
65042
65042
65185
65185
65031
65031
65201
64084
64084
65033
65033
18678
18684
3
1
1
2
1
1
1
2
1
3
3
1
1
1
1
1
2
2
1
1
2
1
2
1
1
2
1
2
1
1
AB
BC
AP
AP
AP
AP
AP
AP
AP
AP
Approval_Date
17‐Sep‐04
19‐Jun‐03
19‐Jun‐03
30‐Jan‐87
26‐Nov‐82
26‐Nov‐82
26‐Nov‐82
31‐Dec‐86
31‐Dec‐86
31‐Dec‐86
24‐May‐89
24‐May‐89
24‐May‐89
31‐Mar‐95
13‐Dec‐05
9‐Nov‐09
26‐Jun‐09
26‐Jun‐09
18‐Jan‐07
24‐Mar‐09
2‐Apr‐13
19‐Dec‐06
19‐Dec‐06
8‐Sep‐82
12‐Oct‐82
3‐Sep‐82
8‐Sep‐82
12‐Oct‐82
3‐Sep‐82
8‐Sep‐82
12‐Oct‐82
3‐Sep‐82
23‐Mar‐11
23‐Mar‐11
18‐Jun‐10
18‐Jun‐10
18‐Jun‐10
9‐May‐97
3‐Dec‐02
11‐May‐10
25‐Aug‐14
7‐Feb‐85
7‐Feb‐85
29‐Oct‐82
26‐Mar‐82
19‐Dec‐86
26‐Mar‐82
19‐Dec‐86
26‐Mar‐82
26‐Mar‐82
26‐Oct‐89
26‐Oct‐89
15‐Oct‐84
15‐Oct‐84
28‐Jul‐09
31‐Aug‐09
29‐Mar‐10
5‐Feb‐13
RLD
Yes
Yes
Yes
Yes
No
No
No
No
Yes
Yes
No
No
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
Yes
No
No
No
No
No
No
No
Yes
Yes
No
Yes
No
No
No
Yes
Yes
No
No
No
No
Type
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
Applicant_Full_Name
MERIDIAN MEDICAL TECHNOLOGIES INC
ABBVIE INC
ABBVIE INC
ABBVIE INC
ABBVIE INC
GLAND PHARMA LTD
HOSPIRA INC
HOSPIRA INC
PLIVA HRVATSKA DOO
SAGENT STRIDES LLC
SAGENT STRIDES LLC
XELLIA PHARMACEUTICALS APS
HOSPIRA INC
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
AKORN INC
NAVINTA LLC
10‐Oct‐85
31‐Jul‐09
25‐May‐95
7‐Sep‐95
17‐Oct‐01
17‐Oct‐01
28‐Jan‐08
28‐Jan‐08
10‐Mar‐00
10‐Mar‐00
13‐Dec‐07
1‐Jun‐96
1‐Jun‐96
27‐Jun‐00
27‐Jun‐00
28‐Sep‐84
28‐Sep‐84
No
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
No
Yes
No
No
No
No
No
Yes
Yes
No
No
No
No
No
No
No
No
No
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
RX
RX
RX
RX
DISCN
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
DISCN
RX
ELI LILLY AND CO
ELI LILLY AND CO
ELI LILLY AND CO
HOSPIRA INC
HOSPIRA INC
PHARMACHEMIE BV
Page 00186
Ingredient
TERBUTALINE SULFATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
ESMOLOL HYDROCHLORIDE
METHOHEXITAL SODIUM
METHOHEXITAL SODIUM
METHOHEXITAL SODIUM
METHOHEXITAL SODIUM
TERBUTALINE SULFATE
GENTAMICIN SULFATE
BUMETANIDE
BUMETANIDE
BUMETANIDE
BUMETANIDE
BUMETANIDE
BUMETANIDE
BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
BUPRENORPHINE HYDROCHLORIDE
BUSULFAN
BUTORPHANOL TARTRATE
DF;Route
Page 00187
Trade_Name
BRETHINE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE
BRETYLIUM TOSYLATE IN DEXTROSE 5%
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER
BRETYLOL
BREVIBLOC
BREVIBLOC
BREVIBLOC
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER
BREVIBLOC IN PLASTIC CONTAINER
BREVITAL SODIUM
BREVITAL SODIUM
BREVITAL SODIUM
BREVITAL SODIUM
BRICANYL
BRISTAGEN
BUMETANIDE
BUMETANIDE
BUMETANIDE
BUMETANIDE
BUMETANIDE
BUMEX
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
BUPIVACAINE HYDROCHLORIDE KIT
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE
BUPRENEX
BUSULFEX
BUTORPHANOL TARTRATE PRESERVATIVE FREE
Applicant
AAIPHARMA LLC
ABRAXIS PHARM
ABRAXIS PHARM
ASTRAZENECA
ASTRAZENECA
ASTRAZENECA
HOSPIRA
INTL MEDICATION
LUITPOLD
ABBOTT
ABBOTT
ABBOTT
B BRAUN
B BRAUN
B BRAUN
BAXTER HLTHCARE
BAXTER HLTHCARE
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
SANOFI AVENTIS US
BRISTOL
WATSON LABS
WATSON LABS
BEDFORD
HIKMA MAPLE HOSPIRA
HOSPIRA
TEVA PARENTERAL
VALIDUS PHARMS INC
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
SAGENT AGILA
SAGENT AGILA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
SEPTODONT
HOSPIRA
HOSPIRA
HOSPIRA
INTL MEDICATED
INTL MEDICATED
INTL MEDICATED
SAGENT AGILA
SAGENT AGILA
SAGENT AGILA
HOSPIRA
RECKITT BENCKISER
EUROHLTH INTL
HOSPIRA
LUITPOLD
OTSUKA PHARM
APOTEX INC
BEDFORD
HIKMA FARMACEUTICA
HIKMA FARMACEUTICA
HIKMA FARMACEUTICA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
APOTEX INC
APOTEX INC
BEDFORD
BEDFORD
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
Strength
1MG/ML
50MG/ML
100MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
200MG/100ML
400MG/100ML
800MG/100ML
100MG/100ML
200MG/100ML
400MG/100ML
200MG/100ML
400MG/100ML
200MG/100ML
400MG/100ML
800MG/100ML
50MG/ML
10MG/ML
10MG/ML
20MG/ML
2GM/100ML
1GM/100ML
2.5GM/VIAL
5GM/VIAL
200MG/VIAL
500MG/VIAL
1MG/ML
EQ 40MG BASE/ML
10MG/ML
100MG/ML
0.25MG/ML
0.25MG/ML
0.25MG/ML
0.25MG/ML
0.25MG/ML
0.25MG/ML
0.25%
0.25%
0.25%
0.25%
0.50%
0.50%
0.50%
0.50%
0.75%
0.75%
0.75%
0.25%
0.50%
0.25%;0.005MG/ML
0.25%;0.005MG/ML
0.25%;0.005MG/ML
0.5%;0.005MG/ML
0.5%;0.005MG/ML
0.5%;0.005MG/ML
0.75%;0.005MG/ML
0.5%;0.0091MG/ML
0.08%
0.11%
0.23%
0.25%
0.50%
0.75%
0.25%
0.50%
0.75%
0.25%
0.50%
0.75%
0.5%;0.0091MG/ML
EQ 0.3MG BASE/ML
EQ 0.3MG BASE/ML
EQ 0.3MG BASE/ML
EQ 0.3MG BASE/ML
6MG/ML
2MG/ML
2MG/ML
1MG/ML
2MG/ML
2MG/ML
1MG/ML
1MG/ML
2MG/ML
2MG/ML
1MG/ML
2MG/ML
1MG/ML
2MG/ML
1MG/ML
1MG/ML
1MG/ML
2MG/ML
2MG/ML
Page 00188
Appl_Type
N
A
A
A
A
A
A
A
N
N
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
N
A
A
A
N
A
A
A
N
A
A
N
A
A
A
A
A
A
A
A
A
A
N
N
N
A
A
A
A
A
A
A
A
A
N
N
A
A
A
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
18571
1
70134
1
71298
1
71151
1
71152
1
71153
1
70545
1
70546
1
19030
1
19033
1
70119
1
70891
1
19005
2
19005
3
19005
1
19121
1
19121
2
19121
3
19837
2
19837
1
19008
2
19008
3
19008
1
17954
1
19386
3
19386
6 AP
19386
7
19386
5
19386
4
11559
2
11559
3
11559
4
11559
1
17466
1
62288
1
83821
1
83820
1
74441
1 AP
79196
1 AP
74160
1
74332
1 AP
74613
1
18226
1
70583
1 AP
70586
1 AP
70590
1 AP
18053
2 AP
70584
1 AP
70597
1 AP
70609
1 AP
18053
1 AP
70585
1 AP
70587
1
18053
3 AP
91503
1 AP
91503
2 AP
71165
1
71166
1
71167
1
71168
1 AP
71169
1
71170
1 AP
71171
1
77250
1 AP
19978
1
19978
2
19978
3
203895
1 AP
203895
2 AP
203895
3 AP
76012
1
76012
2
76012
3
91487
2 AP
91487
1 AP
91487
3 AP
22046
1 AP
18401
1 AP
76931
1 AP
74137
1 AP
78331
1 AP
20954
1
75697
1
75046
1 AP
78400
1 AP
78247
1
78400
2 AP
75342
1
75559
1
75342
2
75559
2
75695
1
75695
2
75045
1 AP
75045
2 AP
74620
1
74626
1 AP
75170
1
74620
2
74626
2 AP
Approval_Date
29‐Apr‐86
13‐Feb‐87
10‐Aug‐87
10‐Aug‐87
10‐Aug‐87
14‐May‐86
14‐May‐86
29‐Apr‐86
29‐Apr‐86
29‐Apr‐86
26‐Jul‐88
29‐Apr‐86
29‐Apr‐86
29‐Apr‐86
29‐Apr‐86
29‐Apr‐86
29‐Apr‐86
12‐Apr‐89
12‐Apr‐89
29‐Apr‐86
29‐Apr‐86
29‐Apr‐86
15‐Aug‐88
25‐Feb‐03
28‐May‐03
27‐Jan‐03
16‐Feb‐01
21‐Dec‐12
27‐Jan‐95
30‐Apr‐08
30‐Oct‐97
31‐Oct‐94
18‐Nov‐97
28‐Feb‐83
17‐Feb‐87
3‐Mar‐87
17‐Feb‐87
17‐Feb‐86
3‐Mar‐87
3‐Mar‐87
3‐Mar‐87
3‐Mar‐87
18‐Oct‐11
18‐Oct‐11
16‐Jun‐88
16‐Jun‐88
16‐Jun‐88
16‐Jun‐88
16‐Jun‐88
16‐Jun‐88
16‐Jun‐88
27‐Sep‐06
3‐Sep‐92
3‐Sep‐92
3‐Sep‐92
5‐Nov‐13
5‐Nov‐13
5‐Nov‐13
9‐Jan‐02
9‐Jan‐02
9‐Jan‐02
18‐Oct‐11
18‐Oct‐11
18‐Oct‐11
13‐Jul‐83
2‐Mar‐05
3‐Jun‐96
27‐Mar‐07
4‐Feb‐99
23‐Oct‐01
12‐Aug‐98
1‐May‐09
29‐Apr‐09
1‐May‐09
4‐Nov‐99
20‐Mar‐00
4‐Nov‐99
20‐Mar‐00
23‐Oct‐01
23‐Oct‐01
12‐Aug‐98
12‐Aug‐98
22‐Jan‐97
23‐Jan‐97
28‐Sep‐98
22‐Jan‐97
23‐Jan‐97
RLD
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
Yes
No
No
No
No
No
No
No
Yes
No
Yes
Yes
Yes
No
Yes
Yes
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Type
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
RX
RX
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
DISCN
RX
RX
DISCN
RX
DISCN
RX
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
RX
DISCN
DISCN
RX
Applicant_Full_Name
AAIPHARMA LLC
ASTRAZENECA LP
ASTRAZENECA LP
ASTRAZENECA LP
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HOSPIRA INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HIKMA MAPLE LTD
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
SAGENT AGILA LLC
SAGENT AGILA LLC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
SEPTODONT INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
INTERNATIONAL MEDICATED SYSTEMS LTD
SAGENT AGILA LLC
SAGENT AGILA LLC
SAGENT AGILA LLC
HOSPIRA INC
HOSPIRA INC
APOTEX INC
HIKMA FARMACEUTICA SA
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
APOTEX INC
APOTEX INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
Page 00189
Ingredient
CALCITRIOL
CALCITRIOL
CALCITONIN SALMON
CALCITONIN SALMON
HEPARIN CALCIUM
CALCITONIN SALMON
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCIUM CHLORIDE
EDETATE CALCIUM DISODIUM
CALCIUM GLUCEPTATE
CALCIUM GLUCEPTATE
CALCIUM GLUCEPTATE
CALCIUM GLUCEPTATE
IRINOTECAN HYDROCHLORIDE
CAPREOMYCIN SULFATE
LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
RUBIDIUM CHLORIDE RB‐82
TECHNETIUM TC‐99M SESTAMIBI KIT
TECHNETIUM TC‐99M TEBOROXIME KIT
DF;Route
LEVOCARNITINE
ALPROSTADIL
ALPROSTADIL
ALPROSTADIL
ALPROSTADIL
ALPROSTADIL
ALPROSTADIL
ALPROSTADIL
ALPROSTADIL
ALPROSTADIL
DESLANOSIDE
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
Page 00190
Trade_Name
CALAN
CALAN
CALCIJEX
CALCIJEX
CALCIMAR
CALCIMAR
CALCIPARINE
CALCITONIN‐SALMON
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCITRIOL
CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER
CALCIUM DISODIUM VERSENATE
CALCIUM GLUCEPTATE
CALCIUM GLUCEPTATE
CALCIUM GLUCEPTATE
CALCIUM GLUCEPTATE
CAMPTOSAR
CAMPTOSAR
CAMPTOSAR
CAPASTAT SULFATE
CARBOCAINE
CARBOCAINE
CARBOCAINE
CARBOCAINE
CARBOCAINE W/ NEO‐COBEFRIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARBOPLATIN
CARDENE
CARDIOGEN‐82
CARDIOGRAFIN
CARDIOLITE
CARDIOTEC
CARDIZEM
CARDIZEM
Applicant
HOSPIRA
GD SEARLE LLC
GD SEARLE LLC
ABBVIE
ABBVIE
SANOFI AVENTIS US
SANOFI AVENTIS US
SANOFI AVENTIS US
ASTRAZENECA
AKORN
AKORN
FRESENIUS KABI USA
FRESENIUS KABI USA
FRESENIUS MEDCL
FRESENIUS MEDCL
HOSPIRA
HOSPIRA
LUITPOLD
LUITPOLD
ROCKWELL MEDCL
SAGENT PHARMS
TEVA PARENTERAL
TEVA PARENTERAL
HOSPIRA
MEDICIS
ABBOTT
ABBOTT
ABRAXIS PHARM
LILLY
PFIZER INC
PFIZER INC
PFIZER INC
AKORN
EASTMAN KODAK
HOSPIRA
HOSPIRA
HOSPIRA
EASTMAN KODAK
CIPLA LTD
CIPLA LTD
CIPLA LTD
EUROHLTH INTL
EUROHLTH INTL
EUROHLTH INTL
FRESENIUS KABI USA
FRESENIUS KABI USA
FRESENIUS KABI USA
HOSPIRA
HOSPIRA
HOSPIRA
ONCO THERAPIES LTD
ONCO THERAPIES LTD
ONCO THERAPIES LTD
PLIVA
PLIVA
PLIVA
SANDOZ
SANDOZ
SANDOZ
WATSON LABS
WATSON LABS
WATSON LABS
CHIESI USA INC
BRACCO
BRACCO
LANTHEUS MEDCL
BRACCO
BIOVAIL
BIOVAIL LABS INTL
CARDIZEM
CARNITOR
CAVERJECT
CAVERJECT
CAVERJECT
CAVERJECT
CAVERJECT
CAVERJECT
CAVERJECT
CAVERJECT IMPULSE
CAVERJECT IMPULSE
CEDILANID‐D
CEFADYL
CEFADYL
CEFADYL
CEFADYL
CEFADYL
CEFADYL
CEFADYL
CEFADYL
CEFADYL
CEFADYL
CEFADYL
CEFADYL
CEFADYL
CEFADYL
CEFAZOLIN AND DEXTROSE
CEFAZOLIN SODIUM
BIOVAIL LABS INTL
SIGMA TAU
PFIZER
PFIZER
PFIZER
NOVARTIS
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
APOTHECON
B BRAUN
B BRAUN
B BRAUN
ABRAXIS PHARM
Strength
2MG/ML
2.5MG/ML
2.5MG/ML
0.001MG/ML
0.002MG/ML
200 IU/ML
400 IU/VIAL
25,000 UNITS/ML
200 IU/ML
0.001MG/ML
0.002MG/ML
0.001MG/ML
0.002MG/ML
0.001MG/ML
0.002MG/ML
0.001MG/ML
0.002MG/ML
0.001MG/ML
0.002MG/ML
0.001MG/ML
0.001MG/ML
0.001MG/ML
0.002MG/ML
100MG/ML
200MG/ML
EQ 90MG CALCIUM/5ML
EQ 90MG CALCIUM/5ML
EQ 90MG CALCIUM/5ML
EQ 90MG CALCIUM/5ML
40MG/2ML (20MG/ML)
100MG/5ML (20MG/ML)
EQ 1GM BASE/VIAL
3%
1%
1.50%
2%
0.05MG/ML;2%
50MG/VIAL
150MG/VIAL
450MG/VIAL
50MG/VIAL
150MG/VIAL
450MG/VIAL
50MG/VIAL
150MG/VIAL
450MG/VIAL
50MG/VIAL
150MG/VIAL
450MG/VIAL
50MG/VIAL
150MG/VIAL
450MG/VIAL
50MG/VIAL
150MG/VIAL
450MG/VIAL
50MG/VIAL
150MG/VIAL
450MG/VIAL
50MG/VIAL
150MG/VIAL
450MG/VIAL
25MG/10ML (2.5MG/ML)
N/A
85%
N/A
N/A
100MG/VIAL
5MG/ML
25MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
200MG/ML
0.005MG/ML
0.01MG/ML
0.02MG/ML
0.005MG/VIAL
0.01MG/VIAL
0.02MG/VIAL
0.04MG/VIAL
0.01MG/VIAL
0.02MG/VIAL
0.2MG/ML
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 20GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
Page 00191
Appl_Type
A
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
A
A
A
N
N
N
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
N
A
A
A
N
A
A
N
N
A
N
N
N
N
A
75170
2
18925
1
19038
1
18874
1 AP
18874
2 AP
17769
1
17497
1
18237
1
73690
1
78066
1 AP
78066
2 AP
75836
1 AP
75836
2 AP
75766
1 AP
75766
2 AP
75816
1
75816
2
75746
1 AP
75746
2 AP
76206
1 AP
77102
1 AP
75823
1
75823
2
21117
1
8922
1
80001
1
83159
1
89373
1
6470
1
20571
1 AP
20571
2 AP
20571
3
50095
1
12125
3
12250
1 AP
12250
5 AP
12250
2 AP
12125
2
77383
1
77383
2
77383
3
76099
1
76099
2
76099
3
76235
1
76235
2
76235
3
76473
1
76473
2
76473
3
91510
1
91510
2
91510
3
76602
1
76602
2
76602
3
76959
1
76959
2
76959
3
76162
1
76162
2
76162
3
19734
1 AP
19414
1
11620
2
19785
1 AP
19928
1
20792
1
20027
1
20027
20182
20755
20755
20755
20379
20379
20379
20379
21212
21212
9282
61769
62724
62961
50446
61769
62724
62961
50446
61769
62961
50446
50446
62961
50446
50779
50779
50779
62688
3
1
1
2
3
3
1
2
4
1
2
2
1
1
2
1
2
2
3
2
3
4
3
4
1
5
2
3
1
3
AP
AP
AP
AP
Approval_Date
28‐Sep‐98
30‐Mar‐84
30‐Mar‐84
25‐Sep‐86
25‐Sep‐86
14‐Apr‐95
29‐Jan‐08
29‐Jan‐08
31‐Dec‐02
31‐Dec‐02
20‐Feb‐03
20‐Feb‐03
16‐Jan‐04
16‐Jan‐04
26‐Sep‐03
26‐Sep‐03
17‐Sep‐03
8‐Feb‐06
31‐Mar‐03
31‐Mar‐03
28‐Jan‐00
30‐Apr‐87
14‐Jun‐96
14‐Jun‐96
5‐Aug‐10
27‐Jan‐06
27‐Jan‐06
27‐Jan‐06
14‐Oct‐04
14‐Oct‐04
14‐Oct‐04
14‐Oct‐04
14‐Oct‐04
14‐Oct‐04
27‐Oct‐04
27‐Oct‐04
27‐Oct‐04
29‐May‐12
29‐May‐12
29‐May‐12
16‐Nov‐04
16‐Nov‐04
16‐Nov‐04
18‐Mar‐05
18‐Mar‐05
18‐Mar‐05
14‐Oct‐04
14‐Oct‐04
14‐Oct‐04
30‐Jan‐92
29‐Dec‐89
21‐Dec‐90
19‐Dec‐90
5‐Sep‐97
24‐Oct‐91
RLD
No
No
No
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
No
No
No
Yes
Yes
Yes
Yes
No
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
Yes
No
No
No
Type
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
RX
DISCN
DISCN
DISCN
Applicant_Full_Name
GD SEARLE LLC
GD SEARLE LLC
ABBVIE INC
ABBVIE INC
ASTRAZENECA LP
AKORN INC
AKORN INC
HOSPIRA INC
HOSPIRA INC
ROCKWELL MEDICAL TECHNOLOGIES INC
HOSPIRA INC
ELI LILLY AND CO
PFIZER INC
PFIZER INC
PFIZER INC
AKORN INC
EASTMAN KODAK CO
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
EASTMAN KODAK CO
CIPLA LTD
CIPLA LTD
CIPLA LTD
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
ONCO THERAPIES LTD
ONCO THERAPIES LTD
ONCO THERAPIES LTD
PLIVA INC
PLIVA INC
PLIVA INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
CHIESI USA INC
BIOVAIL LABORATORIES INTERNATIONAL SRL
18‐Aug‐95
16‐Dec‐92
31‐Oct‐97
1‐Oct‐97
1‐Oct‐97
27‐Jun‐96
6‐Jul‐95
6‐Jul‐95
19‐May‐97
11‐Jun‐02
11‐Jun‐02
23‐Dec‐86
20‐Sep‐88
23‐Dec‐86
20‐Sep‐88
20‐Sep‐88
20‐Sep‐88
27‐Jul‐00
13‐Jan‐12
27‐Jul‐00
17‐Nov‐86
No
Yes
No
No
No
No
No
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
DISCN
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
BIOVAIL LABORATORIES INTERNATIONAL SRL
PFIZER INC
PFIZER INC
PFIZER INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
Page 00192
Ingredient
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFEPIME HYDROCHLORIDE
CEFTIZOXIME SODIUM
CEFTIZOXIME SODIUM
CEFTIZOXIME SODIUM
CEFTIZOXIME SODIUM
CEFTIZOXIME SODIUM
CEFTIZOXIME SODIUM
CEFTIZOXIME SODIUM
CEFTIZOXIME SODIUM
CEFTIZOXIME SODIUM
CEFTIZOXIME SODIUM
CEFMENOXIME HYDROCHLORIDE
CEFOPERAZONE SODIUM
CEFOPERAZONE SODIUM
CEFOPERAZONE SODIUM
CEFOPERAZONE SODIUM
CEFOPERAZONE SODIUM
CEFOPERAZONE SODIUM
CEFOPERAZONE SODIUM
CEFOTETAN DISODIUM
CEFOTETAN DISODIUM
CEFOTETAN DISODIUM
CEFOTETAN DISODIUM
CEFOTETAN DISODIUM
CEFOTETAN DISODIUM
CEFOTETAN DISODIUM
DF;Route
Page 00193
Trade_Name
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFAZOLIN SODIUM
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER
CEFEPIME IN PLASTIC CONTAINER
CEFEPIME IN PLASTIC CONTAINER
CEFIZOX
CEFIZOX
CEFIZOX
CEFIZOX
CEFIZOX
CEFIZOX
CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER
CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER
CEFIZOX IN PLASTIC CONTAINER
CEFIZOX IN PLASTIC CONTAINER
CEFMAX
CEFMAX
CEFMAX
CEFOBID
CEFOBID
CEFOBID
CEFOBID
CEFOBID
CEFOBID IN PLASTIC CONTAINER
CEFOBID IN PLASTIC CONTAINER
CEFOTAN
CEFOTAN
CEFOTAN
CEFOTAN
CEFOTAN
CEFOTAN IN PLASTIC CONTAINER
CEFOTAN IN PLASTIC CONTAINER
Applicant
ABRAXIS PHARM
ABRAXIS PHARM
ABRAXIS PHARM
ACS DOBFAR
ACS DOBFAR
ACS DOBFAR
ACS DOBFAR
AUROBINDO PHARMA
AUROBINDO PHARMA
BEDFORD
BEDFORD
BEDFORD
BEDFORD
BEDFORD
CEPHAZONE PHARMA
CEPHAZONE PHARMA
CEPHAZONE PHARMA
CEPHAZONE PHARMA
FRESENIUS KABI USA
FRESENIUS KABI USA
FRESENIUS KABI USA
FRESENIUS KABI USA
GLAXOSMITHKLINE
HIKMA FARMACEUTICA
HIKMA FARMACEUTICA
HIKMA FARMACEUTICA
HIKMA MAPLE HIKMA MAPLE HIKMA MAPLE HIKMA MAPLE HIKMA MAPLE HIKMA MAPLE HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
SAMSON MEDCL
SAMSON MEDCL
SANDOZ
SANDOZ
SANDOZ
SANDOZ
STERI PHARMA
STERI PHARMA
STERI PHARMA
STERI PHARMA
STERI PHARMA
STERI PHARMA
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
TEVA PHARMS
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
WATSON LABS INC
B BRAUN
B BRAUN
ACS DOBFAR
ACS DOBFAR
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
SANDOZ
SANDOZ
SANDOZ
BAXTER HLTHCARE
BAXTER HLTHCARE
ASTELLAS
ASTELLAS
ASTELLAS
ASTELLAS
ASTELLAS
ASTELLAS
ASTELLAS
ASTELLAS
ASTELLAS
ASTELLAS
TAP PHARM
TAP PHARM
TAP PHARM
PFIZER
PFIZER
PFIZER
PFIZER
PFIZER
PFIZER
PFIZER
ASTRAZENECA
ASTRAZENECA
ASTRAZENECA
ASTRAZENECA
ASTRAZENECA
ASTRAZENECA
ASTRAZENECA
Strength
EQ 10GM BASE/VIAL
EQ 20GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 20GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 5GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 20GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 20GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 5GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 20GM BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 100GM BASE/VIAL
EQ 300GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 20GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 5GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 5GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 20GM BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/50ML (EQ 20MG BASE/ML)
EQ 2GM BASE/100ML (EQ 20MG BASE/ML)
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 20MG BASE/ML
EQ 40MG BASE/ML
EQ 20MG BASE/ML
EQ 40MG BASE/ML
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 20MG BASE/ML
EQ 40MG BASE/ML
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 20MG BASE/ML
EQ 40MG BASE/ML
Page 00194
Appl_Type
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
A
A
A
A
A
A
A
A
A
A
N
N
A
N
A
N
N
N
N
N
N
N
N
N
N
A
N
A
N
N
N
N
A
N
A
N
N
N
N
62688
4
62688
5
62688
2
65303
2 AP
65306
1 AP
65306
2 AP
65303
1 AP
65395
2
65395
1
62894
3
62894
4
62894
5
62894
1
62894
2
65280
2
65295
1
65296
1
65280
1
64169
2
64170
1
64170
2
64169
1
64033
1
65047
2 AP
65143
1 AP
65047
1 AP
62807
3
62807
4
62807
5
62807
6
62807
1
62807
2
65226
2 AP
65244
1 AP
65247
1 AP
65226
1 AP
65141
1
65141
2
62831
2 AP
65345
1 AP
62831
3 AP
62831
1 AP
63207
1 AP
63208
1
63209
1 AP
63209
2 AP
63214
1 AP
63216
1 AP
63016
3
63018
1
63018
2
63016
1
63016
2
62988
3
62989
1
62989
2
62989
3
62988
1
62988
2
50821
1
50821
2
65441
1 AP
65441
2 AP
65369
2 AP
202268
1 AP
65369
3 AP
202268
2 AP
65369
1 AP
90291
2
90291
3
90291
1
50817
1
50817
2
63294
2
50560
2
63294
3
50560
3
50560
5
50560
1
50589
1
50589
2
50589
3
50589
4
50571
2
50571
3
50571
1
63333
1
50551
1
63333
2
50551
2
50551
3
50613
2
50613
1
63293
1
50588
1
63293
2
50588
2
50588
3
50694
2
50694
1
Approval_Date
17‐Nov‐86
3‐Aug‐87
17‐Nov‐86
22‐Oct‐08
22‐Oct‐08
18‐Aug‐14
22‐Oct‐08
8‐Aug‐08
8‐Aug‐08
21‐Jul‐88
21‐Jul‐88
21‐Jul‐88
21‐Jul‐88
21‐Jul‐88
18‐Mar‐09
18‐Mar‐09
18‐Mar‐09
18‐Mar‐09
14‐Aug‐98
18‐Mar‐98
18‐Mar‐98
14‐Aug‐98
31‐Oct‐93
18‐Sep‐01
18‐Oct‐04
18‐Sep‐01
12‐Jan‐88
12‐Jan‐88
12‐Jan‐88
12‐Jan‐88
12‐Jan‐88
12‐Jan‐88
21‐Apr‐05
12‐Aug‐05
12‐Aug‐05
21‐Apr‐05
29‐Nov‐06
29‐Nov‐06
9‐Dec‐88
9‐May‐07
25‐Sep‐92
9‐Dec‐88
27‐Dec‐91
27‐Dec‐91
27‐Dec‐91
30‐Apr‐99
27‐Dec‐91
27‐Dec‐91
14‐Mar‐89
5‐Mar‐90
5‐Mar‐90
14‐Mar‐89
14‐Mar‐89
29‐Dec‐89
29‐Dec‐89
29‐Dec‐89
29‐Dec‐89
29‐Dec‐89
29‐Dec‐89
6‐May‐10
6‐May‐10
20‐Mar‐08
20‐Mar‐08
18‐Jun‐07
30‐Jul‐12
18‐Jun‐07
30‐Jul‐12
18‐Jun‐07
21‐Dec‐10
21‐Dec‐10
21‐Dec‐10
5‐Aug‐08
5‐Aug‐08
31‐Mar‐94
15‐Sep‐83
31‐Mar‐94
15‐Sep‐83
19‐Mar‐93
15‐Sep‐83
3‐Oct‐84
3‐Oct‐84
13‐Apr‐95
13‐Apr‐95
30‐Dec‐87
30‐Dec‐87
30‐Dec‐87
31‐Mar‐95
18‐Nov‐82
31‐Mar‐95
18‐Nov‐82
5‐Mar‐90
31‐Jul‐87
23‐Jul‐86
29‐Apr‐93
27‐Dec‐85
29‐Apr‐93
27‐Dec‐85
25‐Apr‐88
30‐Jul‐93
30‐Jul‐93
RLD
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Type
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
Applicant_Full_Name
ACS DOBFAR SPA
ACS DOBFAR SPA
ACS DOBFAR SPA
ACS DOBFAR SPA
CEPHAZONE PHARMA LLC
GLAXOSMITHKLINE
HIKMA FARMACEUTICA PORTUGAL LDA
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
SAMSON MEDICAL TECHNOLOGIES LLC
SANDOZ INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
STERI PHARMA LLC
STERI PHARMA LLC
STERI PHARMA LLC
STERI PHARMA LLC
STERI PHARMA LLC
STERI PHARMA LLC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
ACS DOBFAR SPA
ACS DOBFAR SPA
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
TAP PHARMACEUTICAL PRODUCTS INC
PFIZER INC
PFIZER INC
Page 00195
Ingredient
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTETAN DISODIUM
CEFOTETAN DISODIUM
CEFOTETAN DISODIUM
CEFOTETAN DISODIUM
CEFOTETAN DISODIUM
CEFOTETAN DISODIUM
CEFOTETAN DISODIUM
CEFOTETAN DISODIUM
CEFOXITIN SODIUM
CEFOXITIN SODIUM
CEFOXITIN SODIUM
CEFOXITIN SODIUM
CEFOXITIN SODIUM
CEFOXITIN SODIUM
CEFOXITIN SODIUM
CEFOXITIN SODIUM
CEFOXITIN SODIUM
CEFOXITIN SODIUM
CEFOXITIN SODIUM
CEFOXITIN SODIUM
CEFOXITIN SODIUM
CEFOXITIN SODIUM
CEFOXITIN SODIUM
CEFOXITIN SODIUM
CEFOXITIN SODIUM
CEFOXITIN SODIUM
CEFOXITIN SODIUM
CEFOXITIN SODIUM
CEFPIRAMIDE SODIUM
CEFPIRAMIDE SODIUM
CEFPIRAMIDE SODIUM
CEFTAZIDIME
CEFTAZIDIME
CEFTAZIDIME
CEFTAZIDIME
CEFTAZIDIME
CEFTAZIDIME
CEFTAZIDIME
CEFTAZIDIME
CEFTAZIDIME
CEFTAZIDIME
CEFTAZIDIME
CEFTAZIDIME SODIUM
CEFTAZIDIME SODIUM
CEFTAZIDIME SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFTRIAXONE SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM
DF;Route
Page 00196
Trade_Name
CEFOTAXIME
CEFOTAXIME
CEFOTAXIME
CEFOTAXIME
CEFOTAXIME
CEFOTAXIME
CEFOTAXIME
CEFOTAXIME
CEFOTAXIME
CEFOTAXIME
CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTETAN
CEFOTETAN
CEFOTETAN
CEFOTETAN
CEFOTETAN
CEFOTETAN
CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER
CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER
CEFOXITIN
CEFOXITIN
CEFOXITIN
CEFOXITIN
CEFOXITIN
CEFOXITIN
CEFOXITIN
CEFOXITIN
CEFOXITIN
CEFOXITIN
CEFOXITIN
CEFOXITIN
CEFOXITIN
CEFOXITIN
CEFOXITIN
CEFOXITIN
CEFOXITIN
CEFOXITIN
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER
CEFPIRAMIDE SODIUM
CEFPIRAMIDE SODIUM
CEFPIRAMIDE SODIUM
CEFTAZIDIME
CEFTAZIDIME
CEFTAZIDIME
CEFTAZIDIME
CEFTAZIDIME
CEFTAZIDIME
CEFTAZIDIME
CEFTAZIDIME
CEFTAZIDIME
CEFTAZIDIME IN DEXTROSE CONTAINER
CEFTAZIDIME IN DEXTROSE CONTAINER
CEFTAZIDIME SODIUM IN PLASTIC CONTAINER
CEFTRIAXONE
CEFTRIAXONE
CEFTRIAXONE
CEFTRIAXONE
CEFTRIAXONE
CEFTRIAXONE
CEFTRIAXONE
CEFTRIAXONE
CEFTRIAXONE
CEFTRIAXONE
CEFTRIAXONE
CEFTRIAXONE
CEFTRIAXONE
CEFTRIAXONE
CEFTRIAXONE
CEFTRIAXONE
CEFTRIAXONE
CEFTRIAXONE
CEFTRIAXONE
CEFTRIAXONE
CEFTRIAXONE
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER
CEFTRIAXONE IN PLASTIC CONTAINER
CEFTRIAXONE IN PLASTIC CONTAINER
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER
Applicant
FRESENIUS KABI USA
FRESENIUS KABI USA
FRESENIUS KABI USA
FRESENIUS KABI USA
FRESENIUS KABI USA
HIKMA
HIKMA
HIKMA
HIKMA
WOCKHARDT
B BRAUN
B BRAUN
AUROBINDO PHARMA
AUROBINDO PHARMA
AUROBINDO PHARMA
CEPHAZONE PHARMA
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
LUPIN
LUPIN
LUPIN
WOCKHARDT
WOCKHARDT
FRESENIUS KABI USA
FRESENIUS KABI USA
FRESENIUS KABI USA
WEST‐WARD PHARM CORP
B BRAUN
B BRAUN
ACS DOBFAR
ACS DOBFAR
ACS DOBFAR
ANTIBIOTICOS BRASIL
ANTIBIOTICOS BRASIL
ANTIBIOTICOS BRASIL
FRESENIUS KABI USA
FRESENIUS KABI USA
FRESENIUS KABI USA
HIKMA FARMACEUTICA
HIKMA FARMACEUTICA
HIKMA FARMACEUTICA
HIKMA MAPLE HIKMA MAPLE HIKMA MAPLE HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
B BRAUN
B BRAUN
WYETH AYERST
WYETH AYERST
WYETH AYERST
ACS DOBFAR
ACS DOBFAR
ACS DOBFAR
ACS DOBFAR
WOCKHARDT
B BRAUN
B BRAUN
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
ACS DOBFAR
ACS DOBFAR
ACS DOBFAR
ACS DOBFAR
AGILA SPECLTS
BEDFORD
FRESENIUS KABI USA
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
LUPIN
SAMSON MEDCL
SANDOZ
SANDOZ INC
SANDOZ INC
STERI PHARMA
TEVA
WOCKHARDT
B BRAUN
B BRAUN
BAXTER HLTHCARE
BAXTER HLTHCARE
B BRAUN
B BRAUN
Strength
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 20GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE
EQ 1GM BASE
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 10GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 2GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
1GM/VIAL
2GM/VIAL
6GM/VIAL
500MG/VIAL
1GM/VIAL
2GM/VIAL
6GM/VIAL
500MG/VIAL
1GM/VIAL
EQ 1GM BASE
EQ 2GM BASE
EQ 10MG BASE/ML
EQ 20MG BASE/ML
EQ 40MG BASE/ML
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 10GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 100GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 20MG BASE/ML
EQ 40MG BASE/ML
EQ 1.5GM BASE/VIAL
EQ 750MG BASE/VIAL
Page 00197
Appl_Type
A
A
A
A
A
A
A
A
A
A
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
A
A
A
A
A
A
A
A
A
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
A
A
N
N
64200
2
64200
3
64201
1
64201
2
64200
1
65072
2 AP
65072
3 AP
65071
1 AP
65072
1 AP
65197
1 AP
50792
1
50792
2
65517
2
65517
3
65517
1
65516
1
65348
1
65290
2 AP
65293
1 AP
65290
3 AP
65293
2 AP
65292
1 AP
65290
1 AP
65124
2 AP
65124
3 AP
65124
1 AP
65197
3 AP
65197
2 AP
65374
1 AP
65374
2 AP
65375
1 AP
91031
1 AP
91031
2 AP
91030
1 AP
65430
1
65430
2
65414
1 AP
65414
2 AP
65415
1 AP
65467
1 AP
65467
2 AP
65464
1 AP
65012
1
65012
2
65011
1
65238
1 AP
65238
2 AP
65239
1 AP
65051
1 AP
65051
2 AP
65050
1 AP
65313
1 AP
65313
2 AP
65312
1 AP
65214
1 AP
65214
2 AP
50633
2
50633
3
50633
5
62640
2 AP
62640
3 AP
62640
4 AP
62640
1 AP
65481
2
65481
3
65482
1
65481
1
65196
1 AP
50823
1
50823
2
63221
1
63221
2
63221
3
65329
2 AP
65329
3 AP
65328
1 AP
65329
1 AP
91068
1
65504
1
65475
1 AP
65252
1
65231
1 AP
202563
1 AP
65231
2 AP
202563
2 AP
65232
1 AP
65263
1 AP
90057
1
65168
1 AP
65204
1 AP
65204
2 AP
65269
1 AP
65274
1
65180
1 AP
50796
1 AP
50796
2 AP
65224
1
65224
2
50780
2 AP
50780
1 AP
Approval_Date
24‐Mar‐00
24‐Mar‐00
24‐Mar‐00
24‐Mar‐00
24‐Mar‐00
20‐Nov‐02
20‐Nov‐02
20‐Nov‐02
20‐Nov‐02
29‐Aug‐06
29‐Jul‐04
29‐Jul‐04
6‐Nov‐09
6‐Nov‐09
6‐Nov‐09
6‐Nov‐09
25‐Jan‐10
11‐Aug‐06
10‐Aug‐06
11‐Aug‐06
10‐Aug‐06
10‐Aug‐06
11‐Aug‐06
24‐Sep‐03
24‐Sep‐03
24‐Sep‐03
20‐Jun‐08
20‐Jun‐08
9‐Aug‐07
9‐Aug‐07
9‐Aug‐07
26‐Oct‐11
26‐Oct‐11
26‐Oct‐11
9‐Aug‐07
9‐Aug‐07
12‐Jun‐09
12‐Jun‐09
19‐May‐10
31‐Aug‐11
31‐Aug‐11
31‐Aug‐11
3‐Jul‐00
3‐Jul‐00
3‐Jul‐00
12‐Mar‐10
12‐Mar‐10
2‐Mar‐10
11‐Sep‐00
11‐Sep‐00
11‐Sep‐00
23‐Jan‐06
23‐Jan‐06
13‐Feb‐06
10‐Mar‐06
10‐Mar‐06
31‐Jan‐89
31‐Jan‐89
31‐Jan‐89
20‐Nov‐85
20‐Nov‐85
3‐Feb‐92
20‐Nov‐85
28‐May‐10
28‐May‐10
28‐May‐10
28‐May‐10
15‐Oct‐08
13‐Jun‐11
13‐Jun‐11
29‐Apr‐93
29‐Apr‐93
29‐Apr‐93
24‐Jul‐08
24‐Jul‐08
24‐Jul‐08
24‐Jul‐08
7‐Jan‐13
31‐Jul‐08
18‐Aug‐08
15‐Feb‐06
2‐Aug‐05
20‐Aug‐12
2‐Aug‐05
20‐Aug‐12
2‐Aug‐05
12‐Sep‐06
25‐Apr‐14
17‐May‐05
3‐May‐05
3‐May‐05
28‐Feb‐07
1‐May‐06
12‐May‐06
20‐Apr‐05
20‐Apr‐05
23‐Aug‐05
23‐Aug‐05
21‐Feb‐01
21‐Feb‐01
RLD
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
Yes
No
No
No
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
Yes
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
Type
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
Applicant_Full_Name
HIKMA FARMACEUTICA LDA
WOCKHARDT LTD
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
LUPIN LTD
LUPIN LTD
LUPIN LTD
WOCKHARDT LTD
WOCKHARDT LTD
WEST‐WARD PHARMACEUTICAL CORP
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
ACS DOBFAR SPA
ACS DOBFAR SPA
ACS DOBFAR SPA
ANTIBIOTICOS DO BRASIL LTDA
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
ACS DOBFAR SPA
ACS DOBFAR SPA
ACS DOBFAR SPA
ACS DOBFAR SPA
WOCKHARDT LTD
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
ACS DOBFAR SPA
ACS DOBFAR SPA
ACS DOBFAR SPA
ACS DOBFAR SPA
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
LUPIN LTD
SANDOZ INC
SANDOZ INC
SANDOZ INC
STERI PHARMA LLC
WOCKHARDT LTD
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
Page 00198
Ingredient
CEFUROXIME SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM
DF;Route
BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEFTAZIDIME
CEFTAZIDIME
CEFTAZIDIME
CEFTAZIDIME
CEFOTIAM HYDROCHLORIDE
FOSPHENYTOIN SODIUM
ALGLUCERASE
ALGLUCERASE
TECHNETIUM TC‐99M EXAMETAZIME KIT
IMIGLUCERASE
IMIGLUCERASE
DAUNORUBICIN HYDROCHLORIDE
CETRORELIX
CETRORELIX
LEVOBUPIVACAINE HYDROCHLORIDE
CHLORAMPHENICOL SODIUM SUCCINATE
CHLORMERODRIN HG‐197
CHLORAMPHENICOL
CHLOROPROCAINE HYDROCHLORIDE
CHLOROTHIAZIDE SODIUM
TECHNETIUM TC‐99M MEBROFENIN KIT
IODIPAMIDE MEGLUMINE
IODIPAMIDE MEGLUMINE
IODIPAMIDE SODIUM
IODOXAMATE MEGLUMINE
IODOXAMATE MEGLUMINE
Page 00199
Trade_Name
CEFUROXIME SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM
CEFUROXIME SODIUM IN PLASTIC CONTAINER
CEFUROXIME SODIUM IN PLASTIC CONTAINER
Applicant
FRESENIUS KABI USA
FRESENIUS KABI USA
HIKMA FARMACEUTICA
HIKMA FARMACEUTICA
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
STERI PHARMA
STERI PHARMA
TEVA PHARMS
WATSON LABS INC
WATSON LABS INC
SAMSON MEDCL
SAMSON MEDCL
CELESTONE
CELESTONE SOLUSPAN
CELLCEPT
CEPHALOTHIN
CEPHALOTHIN
CEPHALOTHIN
CEPHALOTHIN
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM
CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER
CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER
CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPHAPIRIN SODIUM
CEPTAZ
CEPTAZ
CEPTAZ
CEPTAZ
CERADON
CEREBYX
CEREDASE
CEREDASE
CERETEC
CEREZYME
CEREZYME
CERUBIDINE
CERUBIDINE
CERUBIDINE
CETROTIDE
CETROTIDE
CHIROCAINE
CHIROCAINE
CHIROCAINE
CHLOR‐TRIMETON
CHLOR‐TRIMETON
CHLORAMPHENICOL
CHLORMERODRIN HG 197
CHLOROMYCETIN
CHLOROMYCETIN
CHOLETEC
CHOLOGRAFIN MEGLUMINE
CHOLOGRAFIN MEGLUMINE
CHOLOGRAFIN SODIUM
CHOLOVUE
CHOLOVUE
SCHERING
MERCK SHARP DOHME
ROCHE PALO
INTL MEDICATION
INTL MEDICATION
INTL MEDICATION
INTL MEDICATION
ABBOTT
ABBOTT
ABBOTT
ABBOTT
ABRAXIS PHARM
ABRAXIS PHARM
BRISTOL
BRISTOL
BRISTOL
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
ABRAXIS PHARM
ABRAXIS PHARM
ABRAXIS PHARM
ABRAXIS PHARM
ABRAXIS PHARM
HIKMA MAPLE HIKMA MAPLE HIKMA MAPLE HIKMA MAPLE GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
TAKEDA
PARKE DAVIS
GENZYME
GENZYME
GE HEALTHCARE
GENZYME
GENZYME
EUROHLTH INTL
SANOFI AVENTIS US
WYETH AYERST
EMD SERONO INC
EMD SERONO INC
PURDUE PHARMA LP
PURDUE PHARMA LP
PURDUE PHARMA LP
SCHERING PLOUGH
SCHERING PLOUGH
ELKINS SINN
FRESENIUS KABI USA
GRUPPO LEPETIT
BRACCO
PARKE DAVIS
PARKEDALE
EUROHLTH INTL
EUROHLTH INTL
HOSPIRA
HOSPIRA
FRESENIUS KABI USA
LUITPOLD
MYLAN INSTITUTIONAL
SUN PHARMA GLOBAL
BEL MAR
ELKINS SINN
WATSON LABS
WATSON LABS
WATSON LABS
ABRAXIS PHARM
HIKMA MAPLE MARSAM PHARMS LLC
WATSON LABS
WATSON LABS
WYETH AYERST
BRACCO
BRACCO
BRACCO
BRACCO
BRACCO
BRACCO
Strength
EQ 1.5GM BASE/VIAL
EQ 7.5GM BASE/VIAL
EQ 1.5GM BASE/VIAL
EQ 7.5GM BASE/VIAL
EQ 1.5GM BASE/VIAL
EQ 1.5GM BASE/VIAL
EQ 7.5GM BASE/VIAL
EQ 1.5GM BASE/VIAL
EQ 7.5GM BASE/VIAL
EQ 7.5GM BASE/VIAL
EQ 1.5GM BASE/VIAL
EQ 7.5GM BASE/VIAL
EQ 75GM BASE/VIAL
EQ 225GM BASE/VIAL
EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
3MG/ML;EQ 3MG BASE/ML
500MG/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 20MG BASE/ML
EQ 20MG BASE/ML
EQ 20MG BASE/ML
EQ 40MG BASE/ML
EQ 40MG BASE/ML
EQ 40MG BASE/ML
EQ 20MG BASE/ML
EQ 40MG BASE/ML
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 4GM BASE/VIAL
EQ 20GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 20GM BASE/VIAL
EQ 500MG BASE/VIAL
1GM/VIAL
2GM/VIAL
10GM/VIAL
500MG/VIAL
EQ 1GM BASE/VIAL
EQ 50MG PHENYTOIN NA/ML
10 UNITS/ML
80 UNITS/ML
N/A
200 UNITS/VIAL
400 UNITS/VIAL
EQ 20MG BASE/VIAL
EQ 20MG BASE/VIAL
EQ 20MG BASE/VIAL
EQ 0.25MG BASE/ML
EQ 3MG BASE/ML
EQ 2.5MG BASE/ML
EQ 5MG BASE/ML
EQ 7.5MG BASE/ML
10MG/ML
100MG/ML
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
0.6‐1.4mCi/ML
250MG/ML
EQ 1GM BASE/VIAL
2%
3%
2%
3%
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 500MG BASE/VIAL
10MG/ML
10MG/ML
10MG/ML
10MG/ML
100MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
25MG/ML
N/A
10.30%
52%
20%
9.90%
40.30%
Page 00200
Appl_Type
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
N
N
N
N
A
A
N
N
N
N
N
N
N
N
A
A
A
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
65001
2
65002
1
65048
2 AP
65046
1 AP
65483
2 AP
65503
1 AP
65484
1 AP
64125
2 AP
64124
1 AP
64191
1 AP
64035
2
64036
1
65251
1
65251
2
17561
14602
50758
62426
62426
62426
62426
62547
62548
62547
62548
62666
62666
62464
62464
62464
62422
62422
62730
62422
62422
62730
62422
62422
62723
62723
62723
62723
62723
62720
62720
62720
62720
50646
50646
50646
50646
50601
20450
20057
20057
19829
20367
20367
64103
61876
50484
21197
21197
20997
20997
20997
8826
8794
62406
62365
62278
17269
50153
50155
40273
40273
87447
87446
90896
202561
202493
91546
80821
80797
83593
86096
86095
84911
83329
89563
80365
85591
80370
18963
9321
9321
9321
18077
18076
1
1
1
2
3
4
1
1
1
2
2
2
1
1
2
3
3
5
1
4
6
2
1
2
2
3
4
5
1
2
3
4
1
2
3
4
1
1
1
4
3
1
1
2
1
1
1
1
2
1
2
3
1
1
1
1
1
1
1
1
1
2
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
7
3
1
1
1
AB
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
Approval_Date
30‐May‐01
28‐Sep‐98
9‐Jan‐04
9‐Jan‐04
15‐Oct‐08
15‐Oct‐08
15‐Oct‐08
30‐May‐97
30‐May‐97
16‐Apr‐98
26‐Feb‐93
26‐Feb‐93
30‐Dec‐09
30‐Dec‐09
RLD
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Type
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
Applicant_Full_Name
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
STERI PHARMA LLC
STERI PHARMA LLC
12‐Aug‐98
3‐May‐85
3‐May‐85
3‐May‐85
3‐May‐85
11‐Sep‐85
11‐Sep‐85
11‐Sep‐85
11‐Sep‐85
10‐Jun‐87
10‐Jun‐87
7‐May‐84
7‐May‐84
7‐May‐84
31‐Jan‐84
16‐Jul‐91
5‐Mar‐87
31‐Jan‐84
16‐Jul‐91
5‐Mar‐87
31‐Jan‐84
31‐Jan‐84
17‐Nov‐86
17‐Nov‐86
17‐Nov‐86
17‐Nov‐86
17‐Nov‐86
2‐Jul‐87
2‐Jul‐87
2‐Jul‐87
2‐Jul‐87
27‐Sep‐90
27‐Sep‐90
27‐Sep‐90
27‐Sep‐90
30‐Dec‐88
5‐Aug‐96
8‐May‐92
5‐Apr‐91
30‐Dec‐88
23‐May‐94
22‐Sep‐99
3‐Feb‐95
11‐Aug‐00
11‐Aug‐00
5‐Aug‐99
5‐Aug‐99
5‐Aug‐99
9‐Nov‐82
25‐Aug‐82
9‐Sep‐98
9‐Sep‐98
16‐Apr‐82
16‐Apr‐82
16‐Oct‐09
22‐Apr‐13
18‐Jun‐14
26‐Jul‐11
15‐Apr‐88
21‐Jan‐87
No
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
Yes
Yes
No
No
Yes
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
Yes
No
Yes
No
No
No
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
DISCN
DISCN
DISCN
ROCHE PALO ALTO LLC
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HIKMA MAPLE LTD
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
GLAXOSMITHKLINE
TAKEDA CHEMICAL INDUSTRIES LTD
GENZYME CORPORATION
GENZYME CORPORATION
GE HEALTHCARE
GENZYME CORP
GENZYME CORP
WYETH AYERST RESEARCH
EMD SERONO INC
EMD SERONO INC
PURDUE PHARMA LP
PURDUE PHARMA LP
PURDUE PHARMA LP
GRUPPO LEPETIT SPA SUB MERRELL DOW PHARMACEUTICALS INC
HOSPIRA INC
HOSPIRA INC
BEL MAR LABORATORIES INC
HIKMA MAPLE LTD
MARSAM PHARMACEUTICALS LLC
Page 00201
Ingredient
ALBUMIN CHROMATED CR‐51 SERUM
CHROMIC CHLORIDE
CHROMIC CHLORIDE
SODIUM CHROMATE CR‐51
SODIUM CHROMATE CR‐51
CHYMOPAPAIN
DF;Route
CHYMOPAPAIN
CALCITONIN HUMAN
CIDOFOVIR
CIDOFOVIR
CIMETIDINE HYDROCHLORIDE
TECHNETIUM TC‐99M ETIDRONATE KIT
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
TECHNETIUM TC‐99M MEDRONATE KIT
TECHNETIUM TC‐99M PYROPHOSPHATE KIT
CISATRACURIUM BESYLATE
CISPLATIN
CISPLATIN
CISPLATIN
CISPLATIN
CISPLATIN
CISPLATIN
CISPLATIN
CISPLATIN
PRILOCAINE HYDROCHLORIDE
EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE
EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE
CLADRIBINE
CLADRIBINE
CLADRIBINE
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
Page 00202
Trade_Name
CHORIONIC GONADOTROPIN
CHROMALBIN
CHROMALBIN
CHROMALBIN
CHROMIC CHLORIDE
CHROMIC CHLORIDE IN PLASTIC CONTAINER
CHROMITOPE SODIUM
CHROMITOPE SODIUM
CHYMODIACTIN
Applicant
BEL MAR
BEL MAR
FERRING
FERRING
FERRING
FERRING
FERRING
FERRING
FRESENIUS KABI USA
FRESENIUS KABI USA
FRESENIUS KABI USA
FRESENIUS KABI USA
ISO TEX
ISO TEX
ISO TEX
ABRAXIS PHARM
HOSPIRA
BRACCO
BRACCO
CHART MEDCL
CHYMODIACTIN
CIBACALCIN
CIDOFOVIR
CIDOFOVIR
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
CINTICHEM TECHNETIUM 99M HEDSPA
CIPRO
CIPRO
CIPRO
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN
CIPROFLOXACIN IN DEXTROSE 5%
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
CIS‐MDP
CIS‐PYRO
CISATRACURIUM BESYLATE PRESERVATIVE FREE
CISATRACURIUM BESYLATE PRESERVATIVE FREE
CISPLATIN
CISPLATIN
CISPLATIN
CISPLATIN
CISPLATIN
CISPLATIN
CISPLATIN
CISPLATIN
CITANEST
CITANEST
CITANEST
CITANEST FORTE
CITANEST FORTE DENTAL
CITANEST PLAIN
CITANEST PLAIN DENTAL
CLADRIBINE
CLADRIBINE
CLADRIBINE
CLAFORAN
CLAFORAN
CHART MEDCL
NOVARTIS
EMCURE PHARMS LTD
MYLAN INSTITUTIONAL
DAVA PHARMS INC
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
LUITPOLD
TEVA PARENTERAL
VINTAGE PHARMS LLC
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
GE HEALTHCARE
BAYER HLTHCARE
BAYER HLTHCARE
BAYER HLTHCARE
BAYER HLTHCARE
BAYER HLTHCARE
BAYER PHARMS
BEDFORD LABS
BEDFORD LABS
BEDFORD LABS
CLARIS LIFESCIENCES
CLARIS LIFESCIENCES
FRESENIUS KABI USA
FRESENIUS KABI USA
HIKMA FARMACEUTICA
HIKMA FARMACEUTICA
HOSPIRA
HOSPIRA
TEVA PHARMS USA
TEVA PHARMS USA
HIKMA FARMACEUTICA
ACS DOBFAR INFO SA
ACS DOBFAR INFO SA
BAXTER HLTHCARE
BAXTER HLTHCARE
BEDFORD
BEDFORD
CLARIS LIFESCIENCES
CLARIS LIFESCIENCES
HIKMA FARMACEUTICA
HOSPIRA
HOSPIRA
TEVA PHARMS
TEVA PHARMS
PHARMALUCENCE
PHARMALUCENCE
SANDOZ INC
SANDOZ INC
SANDOZ INC
BEDFORD
BEDFORD
EUROHLTH INTL
FRESENIUS KABI USA
HQ SPCLT PHARMA
ONCO THERAPIES LTD
PHARMACHEMIE BV
TEVA PHARMS USA
ASTRAZENECA
ASTRAZENECA
ASTRAZENECA
ASTRAZENECA
DENTSPLY PHARM
ASTRAZENECA
DENTSPLY PHARM
EUROHLTH INTL
FRESENIUS KABI USA
ONCO THERAPIES LTD
SANOFI AVENTIS US
SANOFI AVENTIS US
Strength
5,000 UNITS/VIAL
10,000 UNITS/VIAL
2,000 UNITS/VIAL
2,000 UNITS/VIAL
5,000 UNITS/VIAL
10,000 UNITS/VIAL
15,000 UNITS/VIAL
20,000 UNITS/VIAL
5,000 UNITS/VIAL
10,000 UNITS/VIAL
15,000 UNITS/VIAL
20,000 UNITS/VIAL
100uCi/VIAL
250uCi/VIAL
500uCi/VIAL
EQ 0.004MG CHROMIUM/ML
EQ 0.004MG CHROMIUM/ML
2mCi/VIAL
200uCi/ML
4,000 UNITS/VIAL
10,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
0.5MG/VIAL
EQ 75MG BASE/ML
EQ 75MG BASE/ML
EQ 300MG BASE/2ML
EQ 300MG BASE/2ML
EQ 300MG BASE/2ML
EQ 300MG BASE/2ML
EQ 300MG BASE/2ML
EQ 300MG BASE/2ML
EQ 300MG BASE/2ML
EQ 300MG BASE/2ML
EQ 300MG BASE/2ML
EQ 6MG BASE/ML
EQ 90MG BASE/100ML
EQ 120MG BASE/100ML
EQ 180MG BASE/100ML
EQ 240MG BASE/100ML
EQ 360MG BASE/100ML
EQ 480MG BASE/100ML
N/A
1200MG/120ML (10MG/ML)
200MG/100ML
400MG/200ML
200MG/100ML
1200MG/120ML (10MG/ML)
200MG/100ML
200MG/100ML
400MG/200ML
200MG/100ML
400MG/200ML
200MG/100ML
400MG/200ML
200MG/100ML
400MG/200ML
400MG/200ML
200MG/100ML
400MG/200ML
200MG/100ML
400MG/200ML
N/A
N/A
EQ 2MG BASE/ML
EQ 2MG BASE/ML
EQ 10MG BASE/ML
10MG/VIAL
50MG/VIAL
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1%
2%
3%
0.005MG/ML;4%
0.005MG/ML;4%
4%
4%
1MG/ML
1MG/ML
1MG/ML
EQ 1GM BASE/VIAL
EQ 1GM BASE/VIAL
Page 00203
Appl_Type
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
A
A
A
A
A
A
A
N
A
A
A
N
N
N
N
N
N
N
A
A
A
A
N
17054
1
17054
2
17016
9
17016
11
17016
6
17016
7 AP
17016
10
17016
4
17067
1
17067
2 AP
17067
4
17067
3
17835
1
17835
2
17835
3
19271
1
18961
1
13993
2
13993
1
18663
2
18663
18470
202501
201276
74428
74296
74344
74345
74412
74422
74353
74252
74005
74269
74468
74468
74468
74468
74468
74468
17653
19847
19847
19847
19857
19857
19858
76992
76992
76993
78062
78062
76484
76484
76717
76717
77245
77245
77782
77782
76757
78252
78252
77888
77888
78114
78114
78024
78024
78431
77753
77753
77138
77138
18124
19039
200159
200154
200154
74713
74713
75036
74735
18057
91062
74656
74814
14763
14763
14763
14763
21383
14763
21382
75405
76571
200510
62659
50547
1
1
1
1
1
1
1
1
1
1
1
1
1
1
5
6
3
4
1
2
1
1
2
3
1
2
1
1
2
1
1
2
1
2
1
2
1
2
1
2
1
1
2
1
2
1
2
1
2
1
1
2
1
2
1
1
1
1
2
1
2
1
1
4
1
1
1
4
5
3
8
1
7
1
1
1
1
1
2
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
Approval_Date
27‐Dec‐84
16‐Feb‐90
15‐Feb‐85
5‐May‐87
26‐Jun‐86
21‐Aug‐84
RLD
No
No
No
No
No
Yes
No
No
No
Yes
No
No
No
No
No
No
Yes
No
No
No
Type
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
Applicant_Full_Name
ISO TEX DIAGNOSTICS INC
HOSPIRA INC
CHART MEDICAL INC
10‐Nov‐82
31‐Oct‐86
26‐Jul‐12
27‐Jun‐12
25‐Apr‐96
28‐Mar‐97
31‐Jan‐95
31‐Jan‐95
28‐Mar‐97
31‐Jan‐95
20‐Dec‐94
26‐Nov‐97
31‐Aug‐94
27‐Dec‐94
29‐Dec‐94
29‐Dec‐94
29‐Dec‐94
29‐Dec‐94
29‐Dec‐94
29‐Dec‐94
26‐Dec‐90
26‐Dec‐90
26‐Dec‐90
26‐Dec‐90
26‐Dec‐90
26‐Dec‐90
28‐Aug‐06
28‐Aug‐06
28‐Aug‐06
29‐Apr‐08
29‐Apr‐08
28‐Aug‐06
28‐Aug‐06
22‐Dec‐09
22‐Dec‐09
28‐Aug‐06
28‐Aug‐06
28‐Aug‐06
28‐Aug‐06
21‐Apr‐08
18‐Mar‐08
18‐Mar‐08
18‐Mar‐08
18‐Mar‐08
18‐Mar‐08
18‐Mar‐08
18‐Mar‐08
18‐Mar‐08
18‐Nov‐09
18‐Mar‐08
18‐Mar‐08
18‐Mar‐08
18‐Mar‐08
30‐Jun‐87
3‐Feb‐12
3‐Feb‐12
3‐Feb‐12
14‐Nov‐00
14‐Nov‐00
7‐Nov‐00
16‐Jul‐99
8‐Nov‐88
18‐Apr‐12
16‐May‐00
16‐May‐00
28‐Feb‐00
22‐Apr‐04
6‐Oct‐11
13‐Jan‐87
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
Yes
No
No
No
Yes
No
Yes
Yes
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
RX
RX
RX
RX
RX
CHART MEDICAL INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
GE HEALTHCARE
CLARIS LIFESCIENCES LTD
HOSPIRA INC
HOSPIRA INC
ACS DOBFAR INFO SA
ACS DOBFAR INFO SA
HOSPIRA INC
HOSPIRA INC
PHARMALUCENCE INC
PHARMALUCENCE INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
HQ SPECIALTY PHARMA CORP
ONCO THERAPIES LTD
PHARMACHEMIE BV
ASTRAZENECA LP
ASTRAZENECA LP
ASTRAZENECA LP
ASTRAZENECA LP
ASTRAZENECA LP
ONCO THERAPIES LTD
Page 00204
Ingredient
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
CEFOTAXIME SODIUM
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE
AMINO ACIDS
OLIVE OIL; SOYBEAN OIL
CLONIDINE HYDROCHLORIDE
DF;Route
Page 00205
Trade_Name
CLAFORAN
CLAFORAN
CLAFORAN
CLAFORAN
CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER
CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER
CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
CLEOCIN PHOSPHATE
CLEOCIN PHOSPHATE
CLEOCIN PHOSPHATE
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
Applicant
SANOFI AVENTIS US
SANOFI AVENTIS US
SANOFI AVENTIS US
SANOFI AVENTIS US
SANOFI AVENTIS US
SANOFI AVENTIS US
SANOFI AVENTIS US
SANOFI AVENTIS US
ABRAXIS PHARM
ASTRAZENECA
BEDFORD
BEDFORD
FRESENIUS KABI USA
FRESENIUS KABI USA
HIKMA MAPLE HIKMA MAPLE HIKMA MAPLE HIKMA MAPLE HOSPIRA
HOSPIRA
HOSPIRA
LOCH
MARSAM PHARMS LLC
SAGENT STRIDES
SAGENT STRIDES
SOLOPAK
SOLOPAK
TEVA PARENTERAL
TEVA PARENTERAL
WATSON LABS
WATSON LABS
AKORN INC
AKORN INC
AKORN INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
ABRAXIS PHARM
ABRAXIS PHARM
ABBVIE
ABBVIE
ABBVIE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
Strength
EQ 2GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
EQ 500MG BASE/VIAL
EQ 20MG BASE/ML
EQ 40MG BASE/ML
EQ 20MG BASE/ML
EQ 40MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 6MG BASE/ML
EQ 12MG BASE/ML
EQ 18MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 150MG BASE/ML
EQ 6MG BASE/ML
EQ 12MG BASE/ML
EQ 18MG BASE/ML
EQ 6MG BASE/ML
EQ 12MG BASE/ML
EQ 18MG BASE/ML
EQ 12MG BASE/ML
EQ 900MG BASE/100ML
EQ 6MG BASE/ML
EQ 12MG BASE/ML
EQ 18MG BASE/ML
EQ 6MG BASE/ML
EQ 12MG BASE/ML
EQ 900MG BASE/100ML
2.75%;10GM/100ML
2.75%;25GM/100ML
2.75%;5GM/100ML
4.25%;10GM/100ML
4.25%;20GM/100ML
4.25%;25GM/100ML
4.25%;5GM/100ML
5%;10GM/100ML
5%;15GM/100ML
5%;20GM/100ML
5%;25GM/100ML
5%;35GM/100ML
CLINIMIX E 2.75/10 SULFITE‐FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
BAXTER HLTHCARE
2.75%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;217MG/100ML;112MG/100ML
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
CLINIMIX E 5/10 SULFITE‐FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
BAXTER HLTHCARE
5%;33MG/100ML;10GM/100ML;51MG/100ML;261MG/100ML;340MG/100ML;59MG/100ML
BAXTER HLTHCARE
CLINIMIX E 5/20 SULFITE‐FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER
BAXTER HLTHCARE
BAXTER HLTHCARE
CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER
CLINOLIPID 20%
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
EXELA PHARMA SCS LLC
EXELA PHARMA SCS LLC
FRESENIUS KABI USA
FRESENIUS KABI USA
HIKMA FARMACEUTICA
HIKMA FARMACEUTICA
LUITPOLD
LUITPOLD
15% (15GM/100ML)
16%(160GM/1000ML);4% (40GM/1000ML)
1MG/10ML (0.1MG/ML)
5MG/10ML (0.5MG/ML)
1MG/10ML (0.1MG/ML)
5MG/10ML (0.5MG/ML)
1MG/10ML (0.1MG/ML)
5MG/10ML (0.5MG/ML)
1MG/10ML (0.1MG/ML)
5MG/10ML (0.5MG/ML)
1MG/10ML (0.1MG/ML)
5MG/10ML (0.5MG/ML)
Page 00206
Appl_Type
A
N
N
N
N
N
N
N
A
A
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
A
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
62659
2 AP
50547
3 AP
50547
4 AP
50547
1 AP
50596
2
50596
4
50596
1
50596
3
61839
1
62803
1 AP
50441
1 AP
50639
1 AP
50639
2 AP
50639
3 AP
62747
1
62928
1
63163
1
65206
1 AP
62908
1
65346
1 AP
65347
1 AP
62806
1
62889
1 AP
62953
1
63068
1
62800
1 AP
62801
1 AP
62943
1 AP
62905
1
62913
1
90108
1 AP
90109
1 AP
62819
1
62852
1
63041
1
63282
1
62900
1
63079
1
203048
1 AP
203048
2 AP
203048
3 AP
201692
1 AP
201692
2 AP
201692
3 AP
50636
1
50635
1
65027
1
65027
2
65027
3
50648
1
50648
2
50648
3
20734
2
20734
5
20734
1
20734
8
20734
10
20734
11
20734
7
20734
14
20734
15
20734
16
20734
17
20734
18
20678
2
Approval_Date
13‐Jan‐87
29‐Dec‐83
20‐May‐85
20‐May‐85
20‐May‐85
20‐May‐85
16‐Oct‐87
30‐Aug‐89
30‐Aug‐89
10‐Apr‐91
3‐Jun‐88
13‐Feb‐89
30‐Jun‐94
24‐Sep‐04
1‐Feb‐89
29‐Mar‐07
9‐May‐07
15‐Oct‐87
25‐Apr‐88
21‐Apr‐88
28‐Aug‐89
24‐Jul‐87
24‐Jul‐87
29‐Sep‐88
9‐May‐88
20‐Oct‐88
30‐Sep‐11
30‐Sep‐11
15‐Mar‐88
17‐Mar‐88
29‐Dec‐89
29‐May‐92
8‐Jun‐88
5‐Mar‐90
4‐Apr‐13
4‐Apr‐13
4‐Apr‐13
31‐May‐12
31‐May‐12
31‐May‐12
22‐Dec‐89
22‐Dec‐89
29‐Jun‐01
29‐Jun‐01
29‐Jun‐01
29‐Dec‐89
29‐Dec‐89
29‐Dec‐89
29‐Sep‐97
29‐Sep‐97
29‐Sep‐97
29‐Sep‐97
29‐Sep‐97
29‐Sep‐97
29‐Sep‐97
29‐Sep‐97
29‐Sep‐97
29‐Sep‐97
29‐Sep‐97
29‐Sep‐97
RLD
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Type
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
DISCN
RX
RX
DISCN
RX
DISCN
DISCN
RX
RX
RX
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
26‐Mar‐97 Yes RX
Applicant_Full_Name
ASTRAZENECA LP
BRISTOL MYERS SQUIBB PHARMA CO
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
LOCH PHARMACEUTICALS INC
SAGENT STRIDES LLC
SAGENT STRIDES LLC
SOLOPAK LABORATORIES INC
SOLOPAK LABORATORIES INC
AKORN INC
AKORN INC
AKORN INC
SANDOZ INC
SANDOZ INC
SANDOZ INC
ABBVIE INC
ABBVIE INC
ABBVIE INC
N
20678
5
N
20678
1
N
20678
9
N
20678
11
N
20678
12
N
20678
8
N
20678
16
N
20678
17
N
20678
18
N
20678
19
N
A
N
A
A
A
A
A
A
A
A
A
A
20678
20512
204508
203167
203167
200673
200673
200300
200300
91104
91104
202601
202601
21
1
1
1
2
1
2
1
2
1
2
1
2
26‐Mar‐97
30‐Aug‐96
3‐Oct‐13
29‐Oct‐13
29‐Oct‐13
8‐Jul‐11
8‐Jul‐11
26‐Jan‐11
26‐Jan‐11
8‐Oct‐09
8‐Oct‐09
20‐Feb‐14
20‐Feb‐14
EXELA PHARMA SCIENCES LLC
EXELA PHARMA SCIENCES LLC
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
Yes
No
Yes
No
No
No
No
No
No
No
No
No
No
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
Page 00207
Ingredient
AMDINOCILLIN
AMDINOCILLIN
AMDINOCILLIN
CYANOCOBALAMIN
CYANOCOBALAMIN
COLISTIMETHATE SODIUM
IOTHALAMATE MEGLUMINE
IOTHALAMATE SODIUM
IOTHALAMATE SODIUM
FENOLDOPAM MESYLATE
HYDROCORTISONE
CORTICOTROPIN
CORTICOTROPIN
CORTICOTROPIN
CORTISONE ACETATE
CORTISONE ACETATE
CORTISONE ACETATE
CORTISONE ACETATE
CORTISONE ACETATE
CORTISONE ACETATE
CORTISONE ACETATE
CORTICOTROPIN‐ZINC HYDROXIDE
COSYNTROPIN
IBUTILIDE FUMARATE
DACTINOMYCIN
COSYNTROPIN
COSYNTROPIN
WARFARIN SODIUM
WARFARIN SODIUM
WARFARIN SODIUM
SOMATROPIN
DIGITOXIN
CUPRIC CHLORIDE
CUPRIC SULFATE
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
HYDROXOCOBALAMIN
HYDROXOCOBALAMIN
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
CYCLOSPORINE
CYCLOSPORINE
TRANEXAMIC ACID
DF;Route
CYSTEINE HYDROCHLORIDE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
Page 00208
Trade_Name
COACTIN
COACTIN
COACTIN
COBAVITE
COBAVITE
COGENTIN
COLY‐MYCIN M
COMPAZINE
CONRAY
CONRAY 30
CONRAY 325
CONRAY 400
CONRAY 43
CORDARONE
CORLOPAM
CORTEF
CORTEF ACETATE
CORTICOTROPIN
CORTICOTROPIN
CORTICOTROPIN
CORTISONE ACETATE
CORTISONE ACETATE
CORTISONE ACETATE
CORTISONE ACETATE
CORTISONE ACETATE
CORTONE
CORTONE
CORTRIL
CORTROPHIN‐ZINC
CORTROSYN
CORVERT
COSMEGEN
COSYNTROPIN
COSYNTROPIN
COUMADIN
COUMADIN
COUMADIN
CRESCORMON
CRYSTODIGIN
CUPRIC CHLORIDE IN PLASTIC CONTAINER
CUPRIC SULFATE
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOCOBALAMIN
CYANOKIT
CYANOKIT
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
CYCLOSPORINE
CYCLOSPORINE
CYKLOKAPRON
Applicant
ROCHE
ROCHE
ROCHE
WATSON LABS
WATSON LABS
OAK PHARMS AKORN
EMCURE PHARMS LTD
FRESENIUS KABI USA
PADDOCK LLC
SAGENT PHARMS
X GEN PHARMS
GLAXOSMITHKLINE
MALLINCKRODT
MALLINCKRODT
MALLINCKRODT
MALLINCKRODT
MALLINCKRODT
WYETH PHARMS INC
HOSPIRA
ORGANICS LAGRANGE
ORGANICS LAGRANGE
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
MERCK
MERCK
PFIZER
ORGANON USA INC
AMPHASTAR PHARMS INC
RECORDATI RARE
MYLAN INSTITUTIONAL
SANDOZ
GENENTECH
LILLY
HOSPIRA
ABRAXIS PHARM
ABRAXIS PHARM
ABRAXIS PHARM
ABRAXIS PHARM
AKORN
DELL LABS
DELL LABS
DELL LABS
FRESENIUS KABI USA
HIKMA MAPLE LUITPOLD
LUITPOLD
LYPHOMED
MYLAN INSTITUTIONAL
SANOFI AVENTIS US
SOLOPAK
WARNER CHILCOTT
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WYETH AYERST
WYETH AYERST
MERCK SANTE SAS
MERCK SANTE SAS
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
EUROHLTH INTL
LUITPOLD
CYSTEINE HYDROCHLORIDE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTARABINE
CYTOSAR‐U
HOSPIRA
EUROHLTH INTL
EUROHLTH INTL
EUROHLTH INTL
EUROHLTH INTL
FRESENIUS KABI USA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
ONCO THERAPIES LTD
ONCO THERAPIES LTD
ONCO THERAPIES LTD
ONCO THERAPIES LTD
TEVA PARENTERAL
TEVA PARENTERAL
TEVA PARENTERAL
TEVA PARENTERAL
TEVA PHARMS USA
Strength
1GM/VIAL
250MG/VIAL
500MG/VIAL
0.1MG/ML
1MG/ML
1MG/ML
EQ 150MG BASE/VIAL
EQ 150MG BASE/VIAL
EQ 150MG BASE/VIAL
EQ 150MG BASE/VIAL
EQ 150MG BASE/VIAL
EQ 150MG BASE/VIAL
EQ 5MG BASE/ML
60%
30%
54.30%
66.80%
43%
50MG/ML
EQ 10MG BASE/ML
50MG/ML
50MG/ML
40 UNITS/ML
80 UNITS/ML
40 UNITS/VIAL
25MG/ML
25MG/ML
25MG/ML
50MG/ML
50MG/ML
25MG/ML
50MG/ML
25MG/ML
40 UNITS/ML
0.25MG/VIAL
0.1MG/ML
0.5MG/VIAL
0.25MG/VIAL
0.25MG/VIAL
5MG/VIAL
50MG/VIAL
75MG/VIAL
4 IU/VIAL
0.2MG/ML
EQ 0.4MG COPPER/ML
EQ 0.4MG COPPER/ML
0.03MG/ML
0.1MG/ML
1MG/ML
1MG/ML
0.03MG/ML
0.1MG/ML
1MG/ML
0.1MG/ML
1MG/ML
0.03MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
1MG/ML
0.1MG/ML
0.1MG/ML
1MG/ML
1MG/ML
0.1MG/ML
1MG/ML
2.5GM/VIAL (5GM/KIT)
5GM/VIAL (5GM/KIT)
1GM/VIAL
1GM/VIAL
2GM/VIAL
100MG/VIAL
200MG/VIAL
500MG/VIAL
500MG/VIAL
50MG/ML
50MG/ML
100MG/ML
1GM/VIAL
2GM/VIAL
100MG/VIAL
500MG/VIAL
100MG/ML
20MG/ML
20MG/ML
20MG/ML
100MG/ML
20MG/ML
20MG/ML
20MG/ML
100MG/ML
1GM/VIAL
2GM/VIAL
100MG/VIAL
500MG/VIAL
1GM/VIAL
Page 00209
Appl_Type
N
N
N
A
A
N
A
A
A
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
A
N
A
A
A
A
N
N
N
N
N
N
N
A
A
N
N
N
N
A
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
A
A
A
A
A
A
N
N
A
A
A
A
A
A
A
A
A
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
A
50565
3
50565
1
50565
2
83013
1
83064
1
12015
1 AP
202359
1 AP
65364
1 AP
65177
1 AP
201365
1 AP
64216
1 AP
50108
2 AP
10742
2
13295
1
16983
1
17685
1
14295
1
13295
2
20377
1
19922
1 AP
9864
1
9378
2
10831
1
10831
2
88772
1
8126
2
83147
3
85677
1
83147
4
85677
2
7110
2
7110
3
9164
1
9854
1
16750
1 AP
20491
1 AP
50682
1 AP
90574
1 AP
202147
1 AP
9218
24
9218
20
9218
12
17992
1
84100
5
18960
1
19350
1
80510
3
80510
1
80510
2
87969
1
80689
1
80689
2
80689
3
80557
2
80515
2
80668
1
80737
1 AP
83075
1
40451
1
80564
1
87551
1
7085
2
80573
2
83120
1
80573
1
83120
2
80554
1
80554
2
22041
2
22041
1
40745
2 AP
88374
1
40745
3 AP
88371
1
88372
1
40745
1 AP
88373
1
65004
1 AP
65151
1 AP
19281
1 AP
19523
74245
74245
71471
71472
76512
71868
72168
72945
75383
200914
200915
200916
201784
16793
16793
16793
16793
75206
1
1
2
1
1
1
1
1
1
1
1
1
1
1
3
4
1
2
4
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
Approval_Date
21‐Dec‐84
21‐Dec‐84
21‐Dec‐84
28‐Sep‐12
17‐Apr‐08
19‐Mar‐04
19‐Feb‐14
26‐Feb‐99
3‐Aug‐95
23‐Sep‐97
21‐Nov‐84
28‐Dec‐95
17‐Dec‐09
29‐Jun‐12
7‐Feb‐95
26‐Jun‐86
5‐May‐87
10‐Nov‐83
23‐Sep‐03
29‐Feb‐84
15‐Dec‐06
8‐Apr‐11
21‐May‐08
24‐Sep‐86
21‐May‐08
3‐Jul‐86
3‐Jul‐86
21‐May‐08
3‐Jul‐86
29‐Oct‐99
7‐Oct‐03
30‐Dec‐86
RLD
No
No
No
No
No
Yes
No
No
No
No
No
Yes
No
Yes
Yes
No
No
Yes
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
Yes
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
Yes
No
No
Yes
No
No
No
Yes
Type
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
DISCN
DISCN
RX
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
RX
DISCN
DISCN
RX
DISCN
RX
RX
RX
Applicant_Full_Name
OAK PHARMACEUTICALS INC SUB AKORN INC
GLAXOSMITHKLINE
HOSPIRA INC
ORGANICS LAGRANGE INC
ORGANICS LAGRANGE INC
MERCK AND CO INC
MERCK AND CO INC
ORGANON USA INC
AMPHASTAR PHARMACEUTICALS INC
SANDOZ INC
GENENTECH INC
ELI LILLY AND CO
HOSPIRA INC
AKORN INC
DELL LABORATORIES INC
HIKMA MAPLE LTD
SOLOPAK MEDICAL PRODUCTS INC
WARNER CHILCOTT INC
MERCK SANTE SAS
MERCK SANTE SAS
22‐Oct‐86
31‐Aug‐94
31‐Aug‐94
2‐Aug‐89
2‐Aug‐89
15‐Jan‐04
4‐Jun‐90
31‐Aug‐90
28‐Feb‐94
22‐Nov‐99
13‐Dec‐11
13‐Dec‐11
13‐Dec‐11
30‐Jan‐12
21‐Dec‐87
21‐Dec‐87
30‐Dec‐98
No
No
No
No
No
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
Yes
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
ONCO THERAPIES LTD
ONCO THERAPIES LTD
ONCO THERAPIES LTD
ONCO THERAPIES LTD
Page 00210
Ingredient
CYTARABINE
CYTARABINE
CYTARABINE
GANCICLOVIR SODIUM
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
CYCLOPHOSPHAMIDE
DIHYDROERGOTAMINE MESYLATE
DACARBAZINE
DACARBAZINE
DACARBAZINE
DACARBAZINE
DACARBAZINE
DACARBAZINE
DACARBAZINE
DACARBAZINE
DACARBAZINE
DACTINOMYCIN
DACTINOMYCIN
DEZOCINE
DEZOCINE
DEZOCINE
DANTROLENE SODIUM
DESMOPRESSIN ACETATE
NANDROLONE DECANOATE
DF;Route
DEXAMETHASONE SODIUM PHOSPHATE; LIDOCAINE HYDROCHLORIDE
DEXAMETHASONE ACETATE
DEFEROXAMINE MESYLATE
HYDROXYPROGESTERONE CAPROATE
TESTOSTERONE ENANTHATE
TESTOSTERONE ENANTHATE
ESTRADIOL VALERATE
ESTRADIOL VALERATE
ESTRADIOL VALERATE
TORSEMIDE
TORSEMIDE
MEPERIDINE HYDROCHLORIDE
VALPROATE SODIUM
CYANOCOBALAMIN; TANNIC ACID; ZINC ACETATE
ESTRADIOL CYPIONATE
ESTRADIOL CYPIONATE
ESTRADIOL CYPIONATE
MEDROXYPROGESTERONE ACETATE
ESTRADIOL CYPIONATE; TESTOSTERONE CYPIONATE
TESTOSTERONE CYPIONATE
Page 00211
Trade_Name
CYTOSAR‐U
CYTOSAR‐U
CYTOSAR‐U
CYTOVENE
CYTOXAN
CYTOXAN
CYTOXAN (LYOPHILIZED)
D.H.E. 45
DACARBAZINE
DACARBAZINE
DACARBAZINE
DACARBAZINE
DACARBAZINE
DACARBAZINE
DACARBAZINE
DACARBAZINE
DACARBAZINE
DACTINOMYCIN
DACTINOMYCIN
DALGAN
DALGAN
DALGAN
DANTRIUM
DDAVP
DDAVP
DECA‐DURABOLIN
DECA‐DURABOLIN
DECA‐DURABOLIN
DECADRON
Applicant
TEVA PHARMS USA
TEVA PHARMS USA
TEVA PHARMS USA
ROCHE PALO
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
VALEANT
ABRAXIS PHARM
ABRAXIS PHARM
EUROHLTH INTL
EUROHLTH INTL
FRESENIUS KABI USA
FRESENIUS KABI USA
HOSPIRA
TEVA PHARMS USA
TEVA PHARMS USA
EUROHLTH INTL
LUITPOLD
ASTRAZENECA
ASTRAZENECA
ASTRAZENECA
EUROHLTH INTL
FRESENIUS KABI USA
FRESENIUS KABI USA
TEVA PARENTERAL
TEVA PARENTERAL
TEVA PHARMS USA
SANOFI AVENTIS US
SANOFI AVENTIS US
ORGANON USA INC
ORGANON USA INC
ORGANON USA INC
MERCK
DECADRON
DECADRON W/ XYLOCAINE
MERCK
MERCK
DECADRON‐LA
MERCK
EUROHLTH INTL
EUROHLTH INTL
FRESENIUS KABI USA
FRESENIUS KABI USA
HOSPIRA
HOSPIRA
WATSON LABS
WATSON LABS
DELALUTIN
DELALUTIN
DELALUTIN
DELALUTIN
DELATESTRYL
DELATESTRYL
DELESTROGEN
DELESTROGEN
DELESTROGEN
DEMADEX
DEMADEX
DEMEROL
DEMEROL
DEMEROL
DEMEROL
DEMEROL
DEMEROL
DEMEROL
DEMEROL
DEPACON
DEPINAR
DEPO‐ESTRADIOL
DEPO‐ESTRADIOL
DEPO‐ESTRADIOL
DEPO‐MEDROL
DEPO‐MEDROL
DEPO‐MEDROL
ENDO PHARMS
ENDO PHARMS
ROCHE
ROCHE
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
SANOFI AVENTIS US
SANOFI AVENTIS US
SANOFI AVENTIS US
SANOFI AVENTIS US
ABBVIE
ARMOUR PHARM
DEPO‐PROVERA
DEPO‐PROVERA
DEPO‐PROVERA
DEPO‐TESTADIOL
DEPO‐TESTOSTERONE
DEPO‐TESTOSTERONE
DEPO‐TESTOSTERONE
DESFERAL
DESFERAL
DESMOPRESSIN ACETATE PRESERVATIVE FREE
DEXACEN‐4
NOVARTIS
NOVARTIS
BEDFORD
HOSPIRA
SUN PHARM INDS LTD
TEVA PHARMS USA
BEDFORD
CENT PHARMS
Strength
2GM/VIAL
100MG/VIAL
500MG/VIAL
EQ 500MG BASE/VIAL
100MG/VIAL
200MG/VIAL
1GM/VIAL
1GM/VIAL
2GM/VIAL
2GM/VIAL
500MG/VIAL
500MG/VIAL
1MG/ML
100MG/VIAL
200MG/VIAL
200MG/VIAL
500MG/VIAL
100MG/VIAL
200MG/VIAL
200MG/VIAL
200MG/VIAL
500MG/VIAL
0.5MG/VIAL
0.5MG/VIAL
5MG/ML
10MG/ML
15MG/ML
20MG/VIAL
EQ 5MG BASE/ML
EQ 5MG BASE/VIAL
EQ 20MG BASE/VIAL
EQ 20MG BASE/VIAL
EQ 50MG BASE/VIAL
EQ 5MG BASE/ML
0.004MG/ML
0.015MG/ML
50MG/ML
100MG/ML
200MG/ML
EQ 4MG PHOSPHATE/ML
EQ 24MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
EQ 4MG PHOSPHATE/ML;10MG/ML
EQ 8MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
2GM/VIAL
500MG/VIAL
2GM/VIAL
500MG/VIAL
2GM/VIAL
500MG/VIAL
2GM/VIAL
500MG/VIAL
200MG/ML
200MG/ML
10MG/ML
20MG/ML
40MG/ML
50MG/5ML (10MG/ML)
20MG/2ML (10MG/ML)
25MG/ML
50MG/ML
75MG/ML
100MG/ML
25MG/ML
50MG/ML
75MG/ML
100MG/ML
EQ 100MG BASE/ML
0.5MG/ML;2.3MG/ML;1MG/ML
1MG/ML
3MG/ML
5MG/ML
20MG/ML
40MG/ML
80MG/ML
150MG/ML
400MG/ML
2MG/ML;50MG/ML
50MG/ML
100MG/ML
200MG/ML
2GM/VIAL
500MG/VIAL
0.004MG/ML
0.004MG/ML
0.004MG/ML
0.004MG/ML
0.004MG/ML
EQ 4MG PHOSPHATE/ML
Page 00212
Appl_Type
A
A
A
N
N
N
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
N
A
A
A
A
A
N
N
N
N
N
N
75206
3 AP
75206
1 AP
75206
2 AP
19661
1 AP
12142
1
12142
2
12142
4 AP
12142
10
12142
5 AP
12142
9
12142
3 AP
12142
8
5929
1 AP
70962
1
70990
1
75812
1 AP
75812
2 AP
75371
1 AP
75371
2 AP
75940
1 AP
75259
2 AP
75259
1 AP
90304
1 AP
202562
1 AP
19082
1
19082
2
19082
3
18264
1 AP
50731
1 AP
65034
1
65000
1 AP
64212
1
64212
2
65035
1 AP
18938
1 AP
18938
2
13132
1
13132
2
13132
3
12071
2
Approval_Date
30‐Dec‐98
30‐Dec‐98
30‐Dec‐98
23‐Jun‐89
30‐Aug‐82
24‐Sep‐85
30‐Aug‐82
10‐Dec‐85
4‐Jan‐84
28‐Aug‐86
28‐Aug‐86
15‐Jun‐01
31‐Oct‐02
27‐Aug‐99
27‐Aug‐99
18‐Oct‐01
27‐Aug‐98
22‐Sep‐00
16‐Mar‐10
23‐Aug‐13
29‐Dec‐89
29‐Dec‐89
29‐Dec‐89
30‐Jan‐98
20‐Nov‐01
25‐May‐99
23‐Jun‐98
3‐May‐99
24‐Jan‐00
30‐Mar‐84
25‐Apr‐95
12‐Jun‐86
12‐Jun‐86
12‐Jun‐86
RLD
Yes
No
Yes
Yes
No
No
Yes
No
Yes
No
Yes
No
Yes
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
Yes
Yes
No
No
No
No
No
Yes
No
No
No
No
No
Type
RX
RX
RX
RX
DISCN
DISCN
RX
DISCN
RX
DISCN
RX
DISCN
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
Applicant_Full_Name
ROCHE PALO ALTO LLC
HOSPIRA INC
ASTRAZENECA LP
ASTRAZENECA LP
ASTRAZENECA LP
ORGANON USA INC
ORGANON USA INC
ORGANON USA INC
MERCK AND CO INC
No
No
DISCN MERCK AND CO INC
DISCN MERCK AND CO INC
30‐May‐07
30‐May‐07
15‐Sep‐09
15‐Sep‐09
17‐Mar‐04
17‐Mar‐04
31‐Mar‐06
31‐Mar‐06
No
No
No
No
No
No
No
No
No
DISCN
RX
RX
RX
RX
RX
RX
DISCN
DISCN
N
N
12071
13334
4
2
N
A
A
A
A
A
A
A
A
16675
78086
78086
78718
78718
76019
76019
76806
76806
1
2
1
2
1
2
1
2
1
N
10347
4
No
DISCN BRISTOL MYERS SQUIBB
N
16911
1
No
N
10347
2
No
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
N
N
N
16911
9165
9165
9402
9402
9402
20137
20137
21171
21171
21171
21171
5010
5010
5010
5010
20593
11208
85470
85470
85470
11757
11757
11757
2
1
3
2
4
3
2
1
1
2
3
4
7
2
9
3
1
1
1
2
3
2
1
4
23‐Aug‐93
23‐Aug‐93
30‐Dec‐96
No
No
Yes
Yes
Yes
Yes
No
No
Yes
Yes
Yes
Yes
No
No
No
No
Yes
No
No
No
Yes
Yes
Yes
Yes
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
RX
RX
RX
RX
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
ABBVIE INC
N
N
N
N
A
A
A
N
N
A
A
A
A
A
A
12541
20246
12541
17968
85635
85635
85635
16267
16267
74575
75220
91280
74888
74574
84342
2
1
3
1
1
2
3
2
1
1
1
1
1
1
1
29‐Oct‐92
25‐May‐00
18‐Feb‐00
28‐Aug‐00
25‐Jan‐13
15‐Oct‐97
18‐Feb‐00
No
Yes
Yes
No
No
Yes
Yes
Yes
Yes
No
No
No
No
No
No
DISCN
RX
RX
DISCN
DISCN
RX
RX
RX
RX
DISCN
RX
RX
RX
DISCN
DISCN
HOSPIRA INC
AP
AP
AP
AP
AP
AP
AO
AO
AO
AO
AP
AP
AP
AP
AP
AB
AB
AB
AO
AO
AP
AP
AP
AP
AP
MERCK RESEARCH LABORATORIES DIV MERCK CO INC
HOSPIRA INC
HOSPIRA INC
Page 00213
Ingredient
IRON DEXTRAN
DEXMEDETOMIDINE HYDROCHLORIDE
DEXRAZOXANE HYDROCHLORIDE
DEXTROSE; SODIUM CHLORIDE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DF;Route
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE
DEXTROSE; POTASSIUM CHLORIDE
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
Page 00214
Trade_Name
DEXAMETHASONE
DEXAMETHASONE
DEXFERRUM
DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
DEXTROSE 10% IN PLASTIC CONTAINER
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
Applicant
ABRAXIS PHARM
FRESENIUS KABI USA
WATSON LABS
WATSON LABS
AGILA SPECLTS
AGILA SPECLTS
AKORN
BEL MAR
DELL LABS
FRESENIUS KABI USA
FRESENIUS KABI USA
FRESENIUS KABI USA
HIKMA MAPLE HIKMA MAPLE INTL MEDICATION
LUITPOLD
LYPHOMED
TEVA PARENTERAL
TEVA PARENTERAL
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WYETH AYERST
LUITPOLD
MYLAN INSTITUTIONAL
EUROHLTH INTL
EUROHLTH INTL
MYLAN INSTITUTIONAL
MYLAN INSTITUTIONAL
B BRAUN
B BRAUN
B BRAUN
B BRAUN
B BRAUN
B BRAUN
B BRAUN
B BRAUN
BAXTER HLTHCARE
B BRAUN
B BRAUN
BAXTER HLTHCARE
HOSPIRA
MILES
B BRAUN
B BRAUN
B BRAUN
B BRAUN
B BRAUN
BAXTER HLTHCARE
HOSPIRA
B BRAUN
B BRAUN
Strength
EQ 4MG PHOSPHATE/ML
EQ 10MG PHOSPHATE/ML
EQ 8MG BASE/ML
EQ 16MG BASE/ML
EQ 4MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 4MG PHOSPHATE/ML
EQ 50MG IRON/ML
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
10GM/100ML;110MG/100ML
10GM/100ML;200MG/100ML
10GM/100ML;200MG/100ML
10GM/100ML;330MG/100ML
10GM/100ML;450MG/100ML
10GM/100ML;450MG/100ML
10GM/100ML;900MG/100ML
10GM/100ML;900MG/100ML
10GM/100ML;900MG/100ML
10GM/100ML
10GM/100ML
10GM/100ML
10GM/100ML
10GM/100ML
2.5GM/100ML;110MG/100ML
2.5GM/100ML;200MG/100ML
2.5GM/100ML;330MG/100ML
2.5GM/100ML;450MG/100ML
2.5GM/100ML;450MG/100ML
2.5GM/100ML;450MG/100ML
2.5GM/100ML;450MG/100ML
2.5GM/100ML;900MG/100ML
2.5GM/100ML;900MG/100ML
DEXTROSE 2.5% IN HALF‐STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER
DEXTROSE 2.5% IN PLASTIC CONTAINER
DEXTROSE 25%
B BRAUN
B BRAUN
B BRAUN
BAXTER HLTHCARE
HOSPIRA
HOSPIRA
ABBOTT
B BRAUN
BAXTER HLTHCARE
HOSPIRA
ABBOTT
10MG/100ML;2.5GM/100ML;15MG/100ML;300MG/100ML;160MG/100ML
2.5GM/100ML
2.5GM/100ML
20GM/100ML
20GM/100ML
250MG/ML
3.3GM/100ML;300MG/100ML
3.3GM/100ML;300MG/100ML
30GM/100ML
30GM/100ML
38.5GM/100ML
DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER
B BRAUN
BAXTER HLTHCARE
HOSPIRA
4MG/100ML;4GM/100ML;6MG/100ML;120MG/100ML;62MG/100ML
40GM/100ML
40GM/100ML
DEXTROSE 5% AND ELECTROLYTE NO 75 IN PLASTIC CONTAINER
BAXTER HLTHCARE
5GM/100ML;205MG/100ML;100MG/100ML;120MG/100ML;220MG/100ML
DEXTROSE 5% AND ELECTROLYTE NO.48 IN PLASTIC CONTAINER
BAXTER HLTHCARE
5GM/100ML;31MG/100ML;141MG/100ML;20MG/100ML;12MG/100ML;260MG/100ML
DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER
HOSPIRA
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
HOSPIRA
B BRAUN
B BRAUN
B BRAUN
B BRAUN
MILES
ABBOTT
HOSPIRA
ABBOTT
HOSPIRA
MILES
B BRAUN
B BRAUN
ABBOTT
B BRAUN
B BRAUN
HOSPIRA
MILES
ABBOTT
5GM/100ML;75MG/100ML
5GM/100ML;150MG/100ML
5GM/100ML;224MG/100ML
5GM/100ML;300MG/100ML
33MG/100ML;5GM/100ML;30MG/100ML;860MG/100ML
5GM/100ML;110MG/100ML
5GM/100ML;110MG/100ML
5GM/100ML;200MG/100ML
5GM/100ML;200MG/100ML
5GM/100ML;200MG/100ML
5GM/100ML;225MG/100ML
5GM/100ML;225MG/100ML
5GM/100ML;300MG/100ML
5GM/100ML;300MG/100ML
5GM/100ML;300MG/100ML
5GM/100ML;330MG/100ML
5GM/100ML;330MG/100ML
5GM/100ML;450MG/100ML
5GM/100ML;450MG/100ML
5GM/100ML;450MG/100ML
5GM/100ML;450MG/100ML
5GM/100ML;450MG/100ML
5GM/100ML;900MG/100ML
Page 00215
Appl_Type
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
A
A
A
A
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
88448
1
88469
1
84315
1
87711
1
40803
1 AP
40802
1 AP
84493
1
84752
1
83161
1
84916
1 AP
40491
1 AP
40572
1 AP
84282
1
87702
1 AP
88522
1
87440
1 AP
87065
1
81125
1
81126
1
83702
1
84355
1
89169
1
87668
1
85606
1
85641
1
40024
1 BP
202881
1 AP
203972
1 AP
76068
1 AP
76068
2 AP
200752
1 AP
200752
2 AP
19631
11
18386
1
12
19631
19631
13
18229
1
19631
14
18047
1
19631
15 AP
16696
1 AP
18046
1
19626
4 AP
16694
1 AP
18080
1 AP
18504
1
19631
1
19631
2
19631
3
18030
1
19631
4 AP
16697
1 AP
18096
1
18376
1
19631
5
N
N
N
N
N
N
N
N
N
N
N
19634
18358
19626
17521
18564
19445
18055
19631
17521
19345
18923
N
N
N
19634
17521
18562
1
1
1
4
1
2
1
16
3
1
1
AP
AP
AP
AP
2
2 AP
1 AP
N
18840
1
N
17484
1
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
17608
17634
17634
17634
17634
18254
18030
19631
18030
19631
18399
19482
17606
19486
17799
18501
18030
19631
19484
18030
19631
17607
18400
19483
1
4
1
3
2
1
5
6
4
7
1
1
1
1
1
1
3
8
1
2
9
1
1
1
Approval_Date
25‐Jan‐84
25‐Jan‐84
24‐May‐82
29‐Aug‐08
29‐Aug‐08
11‐Apr‐03
22‐Apr‐05
7‐Sep‐82
17‐Feb‐84
21‐Jul‐82
31‐Aug‐90
31‐Aug‐90
9‐Apr‐86
1‐Jul‐82
23‐Feb‐96
18‐Aug‐14
18‐Aug‐14
28‐Sep‐04
28‐Sep‐04
19‐Oct‐11
19‐Oct‐11
24‐Feb‐88
24‐Feb‐88
24‐Feb‐88
24‐Feb‐88
24‐Feb‐88
2‐Feb‐88
24‐Feb‐88
24‐Feb‐88
24‐Feb‐88
24‐Feb‐88
24‐Feb‐88
RLD
No
No
No
No
No
No
No
No
No
No
Yes
Yes
No
Yes
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
Type
DISCN
DISCN
DISCN
DISCN
RX
RX
DISCN
DISCN
DISCN
RX
RX
RX
DISCN
RX
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
DISCN
RX
DISCN
RX
RX
DISCN
RX
RX
RX
DISCN
RX
RX
RX
DISCN
RX
RX
DISCN
DISCN
RX
Applicant_Full_Name
AKORN INC
HIKMA MAPLE LTD
HIKMA MAPLE LTD
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
HOSPIRA INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
HOSPIRA INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
24‐Feb‐88
2‐Feb‐88
23‐Mar‐82
23‐Nov‐98
19‐Jan‐90
26‐Jan‐85
19‐Sep‐84
No
No
No
Yes
Yes
Yes
No
No
Yes
Yes
No
RX
DISCN
DISCN
RX
RX
RX
DISCN
RX
RX
RX
DISCN
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
HOSPIRA INC
HOSPIRA INC
B BRAUN MEDICAL INC
HOSPIRA INC
24‐Feb‐88 No DISCN B BRAUN MEDICAL INC
Yes RX
HOSPIRA INC
29‐Jun‐83 No
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
RX
No
RX
24‐Feb‐88
24‐Feb‐88
4‐Oct‐85
4‐Oct‐85
24‐Feb‐88
4‐Oct‐85
24‐Feb‐88
4‐Oct‐85
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
RX
RX
RX
RX
RX
RX
DISCN
RX
DISCN
RX
DISCN
DISCN
RX
DISCN
RX
DISCN
DISCN
RX
DISCN
DISCN
RX
RX
DISCN
DISCN
HOSPIRA INC
HOSPIRA INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
HOSPIRA INC
HOSPIRA INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
HOSPIRA INC
Page 00216
Ingredient
DF;Route
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
DEXTROSE
Page 00217
Trade_Name
Applicant
B BRAUN
B BRAUN
HOSPIRA
MILES
Strength
5GM/100ML;900MG/100ML
5GM/100ML;900MG/100ML
5GM/100ML;900MG/100ML
5GM/100ML;900MG/100ML
DEXTROSE 5% IN ACETATED RINGER'S IN PLASTIC CONTAINER
B BRAUN
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER
B BRAUN
B BRAUN
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER
DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075%
MILES
B BRAUN
B BRAUN
B BRAUN
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
DHL
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
B BRAUN
B BRAUN
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
B BRAUN
5GM/100ML
5GM/100ML
50MG/ML
5GM/100ML
5GM/100ML
50MG/ML
50MG/ML
5GM/100ML
5GM/100ML
5GM/100ML
50MG/ML
50MG/ML
5GM/100ML;200MG/100ML
5GM/100ML;330MG/100ML
5GM/100ML;450MG/100ML
5GM/100ML;900MG/100ML
5GM/100ML;75MG/100ML;200MG/100ML
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
B BRAUN
5GM/100ML;150MG/100ML;200MG/100ML
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER B BRAUN
5GM/100ML;220MG/100ML;200MG/100ML
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)
B BRAUN
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
5GM/100ML;300MG/100ML;200MG/100ML
5GM/100ML;75MG/100ML;200MG/100ML
5GM/100ML;150MG/100ML;200MG/100ML
5GM/100ML;224MG/100ML;200MG/100ML
5GM/100ML;150MG/100ML;200MG/100ML
5GM/100ML;300MG/100ML;200MG/100ML
5GM/100ML;224MG/100ML;200MG/100ML
5GM/100ML;300MG/100ML;200MG/100ML
5GM/100ML;75MG/100ML;200MG/100ML
5GM/100ML;150MG/100ML;200MG/100ML
B BRAUN
5GM/100ML;75MG/100ML;330MG/100ML
5GM/100ML;150MG/100ML;330MG/100ML
5GM/100ML;220MG/100ML;330MG/100ML
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER
B BRAUN
5GM/100ML;300MG/100ML;330MG/100ML
BAXTER HLTHCARE
5GM/100ML;75MG/100ML;330MG/100ML
BAXTER HLTHCARE
5GM/100ML;150MG/100ML;330MG/100ML
BAXTER HLTHCARE
5GM/100ML;224MG/100ML;330MG/100ML
BAXTER HLTHCARE
5GM/100ML;150MG/100ML;330MG/100ML
BAXTER HLTHCARE
5GM/100ML;300MG/100ML;330MG/100ML
BAXTER HLTHCARE
5GM/100ML;224MG/100ML;330MG/100ML
BAXTER HLTHCARE
5GM/100ML;300MG/100ML;330MG/100ML
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER BAXTER HLTHCARE
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075%
B BRAUN
5GM/100ML;75MG/100ML;330MG/100ML
5GM/100ML;75MG/100ML;450MG/100ML
5GM/100ML;150MG/100ML;450MG/100ML
5GM/100ML;220MG/100ML;450MG/100ML
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER
B BRAUN
5GM/100ML;300MG/100ML;450MG/100ML
BAXTER HLTHCARE
5GM/100ML;224MG/100ML;450MG/100ML
DEXTROSE 60%
BAXTER HLTHCARE
5GM/100ML;300MG/100ML;450MG/100ML
BAXTER HLTHCARE
5GM/100ML;300MG/100ML;450MG/100ML
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
HOSPIRA
HOSPIRA
HOSPIRA
B BRAUN
B BRAUN
BAXTER HLTHCARE
BAXTER HLTHCARE
HOSPIRA
B BRAUN
BAXTER HLTHCARE
BAXTER HLTHCARE
HOSPIRA
5GM/100ML;75MG/100ML;450MG/100ML
50GM/100ML
50GM/100ML
50GM/100ML
50GM/100ML
500MG/ML
60GM/100ML
60GM/100ML
60GM/100ML
60GM/100ML
60GM/100ML
7.7GM/100ML
70GM/100ML
70GM/100ML
70GM/100ML
Page 00218
Appl_Type
N
N
N
N
18026
1
19631
10 AP
17585
1 AP
18500
1
Approval_Date
24‐Feb‐88
RLD
No
No
No
No
Type
DISCN
RX
RX
DISCN
N
18258
1
Yes RX
N
17510
1
No
N
19634
3 AP
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
18499
16730
19626
16730
16673
20179
16673
20179
19971
19466
19479
16367
19222
18256
20000
16695
16689
16687
16683
16678
18268
1
1
2
2
1
1
3
2
1
1
1
2
1
1
1
1
1
1
1
1
9
N
18268
N
N
N
N
N
N
N
N
N
N
N
24‐Feb‐88 No
Applicant_Full_Name
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
HOSPIRA INC
B BRAUN MEDICAL INC
DISCN B BRAUN MEDICAL INC
RX
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
DHL LABORATORIES INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
2‐Feb‐88
7‐Dec‐92
30‐Oct‐85
7‐Dec‐92
28‐Sep‐95
15‐Jul‐85
17‐Sep‐85
13‐Jul‐84
17‐Apr‐92
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
DISCN
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
DISCN
RX
DISCN
RX
RX
RX
RX
DISCN
4
No
18268
5
No
18268
18037
18037
18037
18037
18037
18037
18037
18037
18037
6
6
7
4
8
1
5
9
2
3
13‐Apr‐82
13‐Apr‐82
13‐Apr‐82
13‐Apr‐82
13‐Apr‐82
No
No
No
No
No
No
No
No
No
No
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
N
18268
11
18‐Jan‐86 No
N
18268
12
18‐Jan‐86 No
N
18268
13
18‐Jan‐86 No
N
18268
14
N
18629
5 AP
23‐Mar‐82 No
RX
N
18629
2 AP
23‐Mar‐82 No
RX
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
AP
18‐Jan‐86 No
B BRAUN MEDICAL INC
N
18629
3 AP
23‐Mar‐82 No
RX
N
18629
4 AP
23‐Mar‐82 No
RX
N
18629
6 AP
23‐Mar‐82 No
RX
N
18629
7 AP
23‐Mar‐82 No
RX
N
18629
8 AP
23‐Mar‐82 No
RX
N
N
18629
18268
1 AP
10
23‐Mar‐82 No
No
RX
N
18268
1
No
N
18268
2
No
N
18268
3
No
N
18008
3
No
DISCN BAXTER HEALTHCARE CORP
N
18008
1
No
DISCN BAXTER HEALTHCARE CORP
N
18008
No
RX
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
18008
17521
20047
18563
19894
19445
17995
17995
17521
20047
19346
19626
17521
20047
18561
2‐Jul‐91
23‐Mar‐82
26‐Dec‐89
3‐Jun‐86
22‐Sep‐82
26‐Mar‐82
2‐Jul‐91
25‐Jan‐85
2‐Feb‐88
26‐Mar‐82
2‐Jul‐91
23‐Mar‐82
No
Yes
Yes
Yes
Yes
No
No
No
Yes
No
No
No
Yes
Yes
Yes
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
RX
DISCN
DISCN
DISCN
RX
RX
RX
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
HOSPIRA INC
B BRAUN MEDICAL INC
HOSPIRA INC
10 AP
2
1
1
1
1
1
2
1
5
2
1
3
6
3
1
AP
AP
AP
AP
AP
AP
AP
AP
AP
Page 00219
Ingredient
DEXTROSE
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZOXIDE
PROCAINE MERETHOXYLLINE; THEOPHYLLINE
ETIDRONATE DISODIUM
FLUCONAZOLE
FLUCONAZOLE
FLUCONAZOLE
FLUCONAZOLE
FLUCONAZOLE
FLUCONAZOLE
DIGOXIN
DIGOXIN
DIGOXIN
DIGOXIN
DIGOXIN
DIGOXIN
DIGOXIN
PHENYTOIN SODIUM
DIMENHYDRINATE
DIMENHYDRINATE
DIMENHYDRINATE
DIMENHYDRINATE
DIMENHYDRINATE
PROPOFOL
PROPOFOL
DIPYRIDAMOLE
DIPYRIDAMOLE
DIPYRIDAMOLE
DIPYRIDAMOLE
DIPYRIDAMOLE
DIPYRIDAMOLE
CHYMOPAPAIN
ESTRADIOL VALERATE; TESTOSTERONE ENANTHATE
DIAZEPAM
DOBUTAMINE HYDROCHLORIDE
DF;Route
Page 00220
Trade_Name
DIAMOX
DIATRIZOATE‐60
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZEPAM
DIAZOXIDE
DICURIN PROCAINE
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE‐FREE)
DIDRONEL
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
DIFLUCAN IN SODIUM CHLORIDE 0.9%
DIFLUCAN IN SODIUM CHLORIDE 0.9%
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
DIGOXIN
DIGOXIN
DIGOXIN
DIGOXIN
DIGOXIN
DIGOXIN
DIGOXIN PEDIATRIC
DILANTIN
DILAUDID
DILAUDID
DILAUDID
DILAUDID‐HP
DILAUDID‐HP
DIMENHYDRINATE
DIMENHYDRINATE
DIMENHYDRINATE
DIMENHYDRINATE
DIMENHYDRINATE
DIMETANE‐TEN
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
DIPRIVAN
DIPRIVAN
DIPYRIDAMOLE
DIPYRIDAMOLE
DIPYRIDAMOLE
DIPYRIDAMOLE
DIPYRIDAMOLE
DIPYRIDAMOLE
DISCASE
DITATE‐DS
DIURIL
DIZAC
Applicant
HOSPIRA
TEVA WOMENS
BRACCO
INTL MEDICATION
ABRAXIS PHARM
HIKMA MAPLE HIKMA MAPLE HIKMA MAPLE HIKMA MAPLE HIKMA MAPLE HIKMA MAPLE HOSPIRA
HOSPIRA
HOSPIRA
MARSAM PHARMS LLC
PARENTA PHARMS
US ARMY
WARNER CHILCOTT
WARNER CHILCOTT
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS
WATSON LABS INC
WATSON LABS INC
ABRAXIS PHARM
LILLY
WATSON LABS
EUROHLTH INTL
MGI PHARMA INC
PFIZER
PFIZER
PFIZER
PFIZER
PFIZER
PFIZER
ABRAXIS PHARM
HIKMA MAPLE HOSPIRA
HOSPIRA
SANDOZ
WYETH AYERST
HOSPIRA
BEDFORD LABS
PADDOCK LLC
PARKE DAVIS
PURDUE PHARM PRODS
PURDUE PHARM PRODS
PURDUE PHARM PRODS
PURDUE PHARM PRODS
PURDUE PHARM PRODS
AGILA SPECLTS
AKORN INC
BEDFORD
HIKMA FARMACEUTICA
HIKMA MAPLE HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
INTL MEDICATION
TEVA PHARMS USA
TEVA PHARMS USA
BAXTER HLTHCARE
FRESENIUS KABI USA
WATSON LABS
WATSON LABS
WYETH AYERST
WYETH AYERST
APP PHARMS
BEL MAR
LYPHOMED
MYLAN INSTITUTIONAL
WATSON LABS
WATSON LABS INC
WATSON LABS INC
WYETH AYERST
ABRAXIS PHARM
BD RX
INTL MEDICATION
WATSON LABS INC
FRESENIUS KABI USA
FRESENIUS KABI USA
AGILA SPECLTS
BEDFORD
FRESENIUS KABI USA
HIKMA MAPLE HOSPIRA
TEVA PHARMS USA
ABBOTT
SAVAGE LABS
OAK PHARMS AKORN
ASTRAZENECA
BAXTER HLTHCARE
EUROHLTH INTL
HOSPIRA
Strength
70GM/100ML
EQ 500MG BASE/VIAL
76%
52%;8%
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
15MG/ML
100MG/ML;50MG/ML
10MG/ML
10MG/ML
50MG/ML
0.25MG/ML
0.25MG/ML
0.25MG/ML
0.25MG/ML
0.25MG/ML
0.25MG/ML
0.1MG/ML
1MG/ML
1MG/ML
50MG/ML
1MG/ML
2MG/ML
4MG/ML
10MG/ML
250MG/VIAL
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
100MG/VIAL
5MG/ML
5MG/ML
10MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
10MG/ML
50MG/ML
10MG/ML
50MG/ML
50MG/ML
50MG/ML
10MG/ML
50MG/ML
10MG/ML
10MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
50MG/ML
10MG/ML
10MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
5MG/ML
12,500 UNITS/VIAL
8MG/ML;180MG/ML
EQ 500MG BASE/VIAL
5MG/ML
EQ 12.5MG BASE/ML
EQ 12.5MG BASE/ML
EQ 12.5MG BASE/ML
EQ 1.25GM BASE/100ML
Page 00221
Appl_Type
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
N
A
A
A
A
A
A
A
A
A
N
A
A
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
A
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
A
A
A
A
A
A
N
A
N
N
A
A
A
A
19893
1 AP
9388
1
10040
17
88166
1
70662
1
70311
1
70312
1
70313
1
71308
1
71309
1
71310
1
71583
1 AP
71584
1
72079
1 AP
72371
1
76815
1
20124
1
71613
1
71614
1
70296
1
70911
1
70912
1
70930
1
72370
1
72397
1
71519
1
8869
1
80614
1
40465
1 AP
19545
1
19950
3 AP
19950
5 AP
19950
1 AP
19950
6 AP
19950
2 AP
19950
4 AP
83217
1
83391
1 AP
40093
1
40206
1
40481
1 AP
84386
1
40092
1
40453
1 AP
40475
1 AP
10151
1
19034
3 AP
19034
4 AP
19034
5 AP
19034
1 AP
19034
2
75375
1
75086
1 AP
74617
1 AP
202651
1 AP
78538
1 AP
74941
1 AP
75004
1
75106
1
75853
1
75749
1 AP
74894
1
74894
2
84767
1
40519
1
80615
1
83531
1
84316
1
11418
2
40466
1 AP
80822
1
80817
2 AP
83183
1
40140
1 AP
87066
1
40498
1 AP
83533
1
80873
1
80873
2
80577
1
80586
2
91526
1 AP
84094
1
80873
3
19627
1
19627
2 AB
75769
1
74939
1 AP
74956
1 AP
74521
1 AP
74601
1
74952
1
18625
1
86423
1
11145
5 AP
19287
1
74098
1
74381
1
74277
1 AP
74634
1
Approval_Date
26‐Dec‐89
5‐Dec‐90
17‐Jun‐83
25‐Jun‐86
16‐Dec‐85
16‐Dec‐85
16‐Dec‐85
17‐Jul‐87
17‐Jul‐87
17‐Jul‐87
13‐Oct‐87
13‐Oct‐87
20‐Dec‐88
29‐Jan‐93
15‐Apr‐04
5‐Dec‐90
22‐Oct‐87
22‐Oct‐87
12‐Feb‐86
28‐Aug‐86
28‐Aug‐86
1‐Dec‐86
29‐Jan‐93
29‐Jan‐93
26‐Aug‐87
11‐Feb‐86
30‐Jun‐03
20‐Apr‐87
29‐Sep‐92
8‐Jul‐94
29‐Jan‐90
29‐Jan‐90
29‐Jan‐90
29‐Jan‐90
16‐May‐96
28‐Aug‐98
21‐Aug‐03
25‐Apr‐96
9‐Jun‐03
28‐Apr‐03
30‐Apr‐09
30‐Apr‐09
30‐Apr‐09
11‐Jan‐84
4‐Aug‐94
30‐Sep‐99
9‐Apr‐98
28‐Feb‐96
9‐Aug‐12
17‐Dec‐08
15‐Apr‐98
16‐Feb‐00
29‐Apr‐99
17‐Dec‐02
21‐Nov‐01
26‐Aug‐97
19‐Apr‐02
23‐Jun‐04
28‐May‐02
20‐Nov‐98
12‐Jul‐05
26‐Mar‐13
2‐Oct‐89
11‐Jun‐96
27‐Nov‐02
13‐Apr‐98
30‐Sep‐98
18‐Oct‐96
19‐Dec‐97
26‐Nov‐97
18‐Jan‐84
18‐Jun‐93
21‐Feb‐95
26‐Sep‐96
31‐Oct‐94
27‐Sep‐96
RLD
Yes
No
No
No
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
No
No
Yes
No
No
No
No
No
Yes
No
No
Yes
No
Yes
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
No
Yes
No
No
No
No
No
No
Yes
No
No
No
No
No
Type
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
RX
RX
RX
RX
RX
DISCN
RX
DISCN
DISCN
RX
DISCN
DISCN
RX
RX
DISCN
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
DISCN
RX
DISCN
RX
DISCN
DISCN
DISCN
DISCN
RX
DISCN
RX
DISCN
RX
DISCN
RX
DISCN
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
RX
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
RX
DISCN
DISCN
DISCN
RX
DISCN
Applicant_Full_Name
HOSPIRA INC
TEVA WOMENS HEALTH INC
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HOSPIRA INC
HOSPIRA INC
PARENTA PHARMACEUTICALS INC
US ARMY MEDICAL RESEARCH MATERIEL COMMAND
ELI LILLY AND CO
MGI PHARMA INC
PFIZER INC
PFIZER INC
PFIZER INC
PFIZER INC
PFIZER INC
PFIZER INC
HIKMA MAPLE LTD
HOSPIRA INC
HOSPIRA INC
SANDOZ CANADA INC
HOSPIRA INC
PURDUE PHARMACEUTICAL PRODUCTS LP
AKORN INC
HIKMA FARMACEUTICA PORTUGAL SA
HIKMA MAPLE LTD
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
APP PHARMACEUTICALS LLC
HIKMA MAPLE LTD
HIKMA MAPLE LTD
HOSPIRA INC
BD RX INC
HIKMA MAPLE LTD
OAK PHARMACEUTICALS INC SUB AKORN INC
ASTRAZENECA LP
HOSPIRA INC
Page 00222
Ingredient
DESOXYCORTICOSTERONE ACETATE
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOPAMINE HYDROCHLORIDE
DOXAPRAM HYDROCHLORIDE
DOXERCALCIFEROL
DOXERCALCIFEROL
DOXERCALCIFEROL
DF;Route
Page 00223
Trade_Name
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
DOBUTREX
DOCA
DOCEFREZ
DOCEFREZ
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOCETAXEL
DOLOPHINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5%
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
DOPRAM
DOXERCALCIFEROL
DOXERCALCIFEROL
DOXERCALCIFEROL
Applicant
HOSPIRA
HOSPIRA
LUITPOLD
TEVA PARENTERAL
WATSON LABS
WATSON LABS INC
WATSON LABS INC
HOSPIRA
HOSPIRA
HOSPIRA
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
LILLY
ORGANON USA INC
SUN PHARMA GLOBAL
SUN PHARMA GLOBAL
ACCORD HLTHCARE
ACCORD HLTHCARE
ACCORD HLTHCARE
ACCORD HLTHCARE
ACCORD HLTHCARE
ACTAVIS INC
ACTAVIS INC
ACTAVIS INC
APOTEX INC
APOTEX INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
PFIZER LABS
PFIZER LABS
PFIZER LABS
PFIZER LABS
SANDOZ
SANDOZ
SANDOZ
MYLAN INSTITUTIONAL
ABBOTT
ABBOTT
ABRAXIS PHARM
ABRAXIS PHARM
ABRAXIS PHARM
ABRAXIS PHARM
ABRAXIS PHARM
ASTRAZENECA
ASTRAZENECA
ASTRAZENECA
ASTRAZENECA
ASTRAZENECA
ASTRAZENECA
ASTRAZENECA
ASTRAZENECA
BAXTER HLTHCARE
BAXTER HLTHCARE
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
HOSPIRA
INTL MEDICATION
LUITPOLD
LUITPOLD
LUITPOLD
LYPHOMED
SMITH AND NEPHEW
SMITH AND NEPHEW
SMITH AND NEPHEW
TEVA PARENTERAL
TEVA PARENTERAL
WARNER CHILCOTT
WARNER CHILCOTT
WARNER CHILCOTT
B BRAUN
B BRAUN
B BRAUN
B BRAUN
HOSPIRA
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
BAXTER HLTHCARE
HOSPIRA
HOSPIRA
HOSPIRA
HIKMA MAPLE BEDFORD
WATSON LABS
HIKMA PHARMS LLC
SANDOZ
SANDOZ
ACTAVIS INC
ALVOGEN INC
EUROHLTH INTL
EUROHLTH INTL
Strength
EQ 12.5MG BASE/ML
EQ 12.5MG BASE/ML
EQ 12.5MG BASE/ML
EQ 12.5MG BASE/ML
EQ 12.5MG BASE/ML
EQ 12.5MG BASE/ML
EQ 12.5MG BASE/ML
EQ 50MG BASE/100ML
EQ 100MG BASE/100ML
EQ 200MG BASE/100ML
EQ 50MG BASE/100ML
EQ 100MG BASE/100ML
EQ 200MG BASE/100ML
EQ 400MG BASE/100ML
EQ 50MG BASE/100ML
EQ 100MG BASE/100ML
EQ 200MG BASE/100ML
EQ 400MG BASE/100ML
EQ 12.5MG BASE/ML
5MG/ML
20MG/VIAL
80MG/VIAL
20MG/ML (20MG/ML)
80MG/2ML (40MG/ML)
80MG/4ML (20MG/ML)
160MG/8ML (20MG/ML)
20MG/ML (20MG/ML)
80MG/4ML (20MG/ML)
140MG/7ML (20MG/ML)
80MG/2ML (40MG/ML)
20MG/2ML (10MG/ML)
80MG/8ML (10MG/ML)
20MG/2ML (10MG/ML)
80MG/8ML (10MG/ML)
20MG/2ML (10MG/ML)
80MG/8ML (10MG/ML)
10MG/ML
40MG/ML
80MG/ML
40MG/ML
40MG/ML
80MG/ML
80MG/ML
160MG/ML
40MG/ML
40MG/ML
80MG/ML
80MG/ML
80MG/ML
160MG/ML
160MG/ML
160MG/ML
40MG/ML
80MG/ML
40MG/ML
40MG/ML
80MG/100ML
80MG/ML
160MG/100ML
40MG/ML
40MG/ML
80MG/ML
160MG/ML
40MG/ML
40MG/ML
40MG/ML
80MG/ML
40MG/ML
80MG/ML
40MG/ML
40MG/ML
80MG/ML
80MG/100ML
320MG/100ML
40MG/100ML
160MG/100ML
1.6MG/ML
80MG/100ML
160MG/100ML
320MG/100ML
640MG/100ML
80MG/100ML
160MG/100ML
320MG/100ML
20MG/ML
20MG/ML
20MG/ML
4MCG/2ML (2MCG/ML)
4MCG/2ML (2MCG/ML)
4MCG/2ML (2MCG/ML)
2MG/ML
2MG/ML
2MG/ML
10MG/VIAL
Page 00224
Appl_Type
A
A
A
A
A
A
A
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
N
A
A
A
A
A
A
N
N
A
N
N
N
N
N
A
A
A
N
A
A
A
A
A
A
N
A
N
N
N
N
N
N
N
N
N
N
N
N
N
A
A
A
A
A
A
A
A
A
74086
1 AP
74292
1 AP
74545
1
74206
1
74114
1
74279
1
74995
1
20269
1
20269
2
20269
3
20255
1 AP
20255
3 AP
20255
4 AP
20255
5 AP
20201
3 AP
20201
2 AP
20201
1 AP
20201
6 AP
17820
2
1104
1
22534
1
22534
2
201195
1
201195
3 AP
201195
2
201195
4 AP
201195
5 AP
203551
1 AP
203551
2 AP
203551
3
22312
1
22312
2
22234
1 AP
22234
2 AP
22234
3 AP
202356
1
202356
2
202356
3
202356
4
201525
1 AP
201525
2 AP
201525
3 AP
21624
1
70656
1
70657
1
70012
1
70058
1
70013
1
70059
1
70364
1
70087
1
18656
1
70089
1
70090
1
70091
1
70092
1
70093
1
70094
1
18398
1
18398
2
74403
1
18132
1 AP
18132
2 AP
18132
4 AP
18132
3 AP
18014
1
70799
1 AP
70820
1 AP
70826
1 AP
18549
1
70011
1
70046
1
70047
1
72999
1
73000
1
70558
1
18138
1
70559
1
19099
2 AP
19099
4 AP
19099
1
19099
3 AP
20542
1
19615
1 AP
19615
2 AP
19615
3 AP
19615
4
18826
1 AP
18826
2 AP
18826
3 AP
14879
1 AP
76266
1 AP
73529
1
91101
1 AP
91333
1 AP
200926
1 AP
203622
1 AP
65515
1 AP
62975
1 AP
62921
1 AP
Approval_Date
29‐Nov‐93
16‐Feb‐95
25‐Jun‐98
19‐Oct‐93
30‐Nov‐93
18‐Feb‐98
31‐Mar‐98
19‐Oct‐93
19‐Oct‐93
19‐Oct‐93
19‐Oct‐93
19‐Oct‐93
19‐Oct‐93
19‐Oct‐93
19‐Oct‐93
19‐Oct‐93
19‐Oct‐93
7‐Jul‐94
3‐May‐11
3‐May‐11
8‐Jun‐11
20‐Apr‐12
8‐Jun‐11
20‐Apr‐12
20‐Apr‐12
12‐Apr‐13
12‐Apr‐13
12‐Apr‐13
11‐Jan‐12
11‐Jan‐12
8‐Mar‐11
8‐Mar‐11
8‐Mar‐11
13‐Mar‐14
13‐Mar‐14
13‐Mar‐14
13‐Mar‐14
29‐Jun‐11
29‐Jun‐11
29‐Jun‐11
24‐Jan‐89
24‐Jan‐89
12‐Jun‐85
20‐Mar‐85
12‐Jun‐85
20‐Mar‐85
4‐Dec‐85
23‐Oct‐85
28‐Jun‐83
23‐Oct‐85
23‐Oct‐85
23‐Oct‐85
23‐Oct‐85
23‐Oct‐85
23‐Oct‐85
22‐Mar‐82
23‐May‐96
4‐Feb‐82
9‐Jul‐82
4‐Feb‐82
11‐Feb‐87
11‐Feb‐87
11‐Feb‐87
11‐Mar‐83
29‐Aug‐85
29‐Aug‐85
29‐Aug‐85
23‐Oct‐91
23‐Oct‐91
20‐Sep‐85
20‐Sep‐85
15‐Oct‐86
15‐Oct‐86
15‐Oct‐86
15‐Oct‐86
30‐Aug‐95
27‐Mar‐87
27‐Mar‐87
27‐Mar‐87
27‐Mar‐87
30‐Sep‐83
30‐Sep‐83
30‐Sep‐83
10‐Jan‐03
30‐Jan‐92
30‐Aug‐13
5‐May‐14
4‐Feb‐14
27‐Jun‐14
8‐Nov‐12
17‐Mar‐89
17‐Mar‐89
RLD
No
Yes
No
No
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
Yes
Yes
No
No
No
No
Yes
No
No
No
No
No
Yes
Yes
Yes
No
No
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
Yes
Yes
No
Yes
Yes
Yes
No
No
No
No
No
No
No
No
No
Yes
Yes
Yes
Yes
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
No
No
No
No
No
No
Yes
Yes
Type
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
RX
RX
RX
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
DISCN
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
RX
RX
DISCN
RX
RX
RX
RX
RX
RX
RX
Applicant_Full_Name
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
ELI LILLY AND CO
ORGANON USA INC
ACTAVIS INC
ACTAVIS INC
ACTAVIS INC
APOTEX INC
APOTEX INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
PFIZER LABS
PFIZER LABS
PFIZER LABS
PFIZER LABS
SANDOZ
SANDOZ
SANDOZ
ASTRAZENECA LP
ASTRAZENECA LP
ASTRAZENECA LP
ASTRAZENECA LP
ASTRAZENECA LP
ASTRAZENECA LP
ASTRAZENECA LP
ASTRAZENECA LP
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
B BRAUN MEDICAL INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HOSPIRA INC
HIKMA MAPLE LTD
SANDOZ INC
SANDOZ INC
ACTAVIS INC
ALVOGEN INC
Page 00225
Ingredient
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE
TECHNETIUM TC‐99M MEDRONATE
TECHNETIUM TC‐99M MEDRONATE
DROMOSTANOLONE PROPIONATE
DROPERIDOL
DROPERIDOL
DROPERIDOL
DROPERIDOL
DROPERIDOL
DROPERIDOL
DROPERIDOL
DROPERIDOL
DROPERIDOL
DROPERIDOL
DROPERIDOL
DROPERIDOL
DROPERIDOL
DROPERIDOL
DROPERIDOL
DROPERIDOL
DROPERIDOL
DACARBAZINE
DACARBAZINE
TECHNETIUM TC‐99M PENTETATE KIT
BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE
NANDROLONE PHENPROPIONATE
NANDROLONE PHENPROPIONATE
PENICILLIN G PROCAINE
MORPHINE SULFATE
MORPHINE SULFATE
EPINEPHRINE; ETIDOCAINE HYDROCHLORIDE
EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE
ETIDOCAINE HYDROCHLORIDE
ETIDOCAINE HYDROCHLORIDE
ETHACRYNATE SODIUM
ALPROSTADIL
ALPROSTADIL
ALPROSTADIL
ALPROSTADIL
ALPROSTADIL
ALPROSTADIL
ALPROSTADIL
EDROPHONIUM CHLORIDE
AMITRIPTYLINE HYDROCH

Medac Exhibit 2087 Frontier Therapeutics v. Medac

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