Ingredient
`BETAMETHASONE VALERATE
`CLINDAMYCIN PHOSPHATE
`CLOBETASOL PROPIONATE
`CLOBETASOL PROPIONATE
`ECONAZOLE NITRATE
`CLINDAMYCIN PHOSPHATE
`KETOCONAZOLE
`TAZAROTENE
`KETOCONAZOLE
`BETAMETHASONE VALERATE
`MINOXIDIL
`MINOXIDIL
`CLOBETASOL PROPIONATE
`CLOBETASOL PROPIONATE
`CALCIPOTRIENE
`DESONIDE
`MINOXIDIL
`FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
`FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
`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
`FLUTICASONE PROPIONATE
`FLUTICASONE PROPIONATE
`FLUTICASONE PROPIONATE
`FLUTICASONE PROPIONATE
`FLUTICASONE PROPIONATE
`CROMOLYN SODIUM
`ISOETHARINE MESYLATE
`ISOPROTERENOL HYDROCHLORIDE
`ISOPROTERENOL HYDROCHLORIDE
`ISOPROTERENOL HYDROCHLORIDE
`PIRBUTEROL ACETATE
`PIRBUTEROL ACETATE
`ERGOTAMINE TARTRATE
`EPINEPHRINE BITARTRATE
`ISOPROTERENOL SULFATE
`EPINEPHRINE
`ALBUTEROL SULFATE
`ALBUTEROL
`ALBUTEROL SULFATE
`BECLOMETHASONE DIPROPIONATE
`BECLOMETHASONE DIPROPIONATE
`SALMETEROL XINAFOATE
`BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
`BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
`NEDOCROMIL SODIUM
`BITOLTEROL MESYLATE
`BECLOMETHASONE DIPROPIONATE
`BECLOMETHASONE DIPROPIONATE
`ALBUTEROL
`ALBUTEROL SULFATE
`LEVALBUTEROL TARTRATE
`TALC
`BECLOMETHASONE DIPROPIONATE
`TRIAMCINOLONE ACETONIDE
`BECLOMETHASONE DIPROPIONATE
`BUDESONIDE
`BECLOMETHASONE DIPROPIONATE
`CICLESONIDE
`HYDROCORTISONE ACETATE
`NITROGLYCERIN
`HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
`CHLORHEXIDINE GLUCONATE
`HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
`HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
`DEXAMETHASONE SODIUM PHOSPHATE
`LIDOCAINE
`NITROGLYCERIN
`
`DEXAMETHASONE
`HYDROCORTISONE
`
`DF;Route
`AEROSOL, FOAM;TOPICAL
`AEROSOL, FOAM;TOPICAL
`AEROSOL, FOAM;TOPICAL
`AEROSOL, FOAM;TOPICAL
`AEROSOL, FOAM;TOPICAL
`AEROSOL, FOAM;TOPICAL
`AEROSOL, FOAM;TOPICAL
`AEROSOL, FOAM;TOPICAL
`AEROSOL, FOAM;TOPICAL
`AEROSOL, FOAM;TOPICAL
`AEROSOL, FOAM;TOPICAL
`AEROSOL, FOAM;TOPICAL
`AEROSOL, FOAM;TOPICAL
`AEROSOL, FOAM;TOPICAL
`AEROSOL, FOAM;TOPICAL
`AEROSOL, FOAM;TOPICAL
`AEROSOL, FOAM;TOPICAL
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INHALATION
`AEROSOL, METERED;INTRAPLEURAL
`AEROSOL, METERED;NASAL
`AEROSOL, METERED;NASAL
`AEROSOL, METERED;NASAL
`AEROSOL, METERED;NASAL
`AEROSOL, METERED;NASAL
`AEROSOL, METERED;NASAL
`AEROSOL, METERED;RECTAL
`AEROSOL, METERED;SUBLINGUAL
`AEROSOL, METERED;TOPICAL
`AEROSOL, METERED;TOPICAL
`AEROSOL, METERED;TOPICAL
`AEROSOL, METERED;TOPICAL
`AEROSOL;NASAL
`AEROSOL;ORAL
`AEROSOL;SUBLINGUAL
`
`AEROSOL;TOPICAL
`AEROSOL;TOPICAL
`
`Medac Exhibit 2087
`Koios Pharmaceuticals v. Medac
`IPR2016-01370
`Page 00001
`
`

`

`Trade_Name
`BETAMETHASONE VALERATE
`CLINDAMYCIN PHOSPHATE
`CLOBETASOL PROPIONATE
`CLOBETASOL PROPIONATE
`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
`ISOETHARINE MESYLATE
`ISOPROTERENOL HYDROCHLORIDE
`ISOPROTERENOL HYDROCHLORIDE
`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
`
`AEROSEB‐DEX
`AEROSEB‐HC
`
`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
`BOEHRINGER INGELHEIM
`BOEHRINGER INGELHEIM
`ABBVIE
`GLAXOSMITHKLINE
`NOVARTIS
`SANOFI AVENTIS US
`BLAIREX
`WYETH CONS
`STERLING
`SANOFI AVENTIS US
`BOEHRINGER INGELHEIM
`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
`
`ALLERGAN HERBERT
`ALLERGAN HERBERT
`
`Strength
`
`0.045MG/INH;EQ 0.021MG BASE/INH
`0.115MG/INH;EQ 0.021MG BASE/INH
`0.23MG/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
`
`0.3MG/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
`0.005MG/INH;0.2MG/INH
`0.16MG/INH;0.24MG/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
`0.08MG/INH;0.0045MG/INH
`0.16MG/INH;0.0045MG/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
`
`0.4MG/SPRAY
`1%;1%
`
`1%;1%
`1%;1%
`EQ 0.1MG PHOSPHATE/INH
`
`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%
`
`0.90%
`
`10%
`
`4%
`
`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 Appl_No Product_No TE_Code
`A
`78337
`1 AB
`A
`90785
`1 AT
`A
`77763
`1 AB1
`A
`201402
`1 AB2
`N
`205175
`1
`N
`50801
`1 AT
`N
`21738
`1 AT
`N
`202428
`1
`A
`91550
`1 AT
`N
`20934
`1 AB
`N
`21812
`1
`A
`91344
`1
`N
`21142
`1 AB1
`N
`22013
`1 AB2
`N
`22563
`1
`N
`21978
`1
`N
`21812
`2
`N
`21254
`1
`N
`21254
`2
`N
`21254
`3
`N
`18340
`1
`N
`21247
`1
`A
`72273
`1
`A
`73045
`1
`A
`73272
`1
`A
`74072
`1
`N
`16402
`1
`N
`21658
`2
`N
`21658
`3
`N
`205641
`1
`N
`205641
`2
`N
`20056
`1
`N
`19085
`1
`N
`21527
`1
`N
`18117
`1
`N
`18153
`1
`N
`18762
`1
`N
`18000
`1
`N
`19912
`1
`N
`16126
`2
`N
`16803
`1
`N
`12339
`7
`N
`20291
`1
`N
`13413
`1
`N
`22518
`1
`N
`22518
`2
`N
`13296
`1
`A
`87907
`1
`N
`20548
`1
`N
`20548
`2
`N
`20548
`3
`N
`21433
`3
`N
`21433
`2
`N
`21433
`1
`N
`18887
`1
`A
`87858
`1
`N
`10375
`4
`A
`85904
`1
`N
`11178
`1
`N
`20014
`1
`N
`19009
`1
`N
`12102
`1
`N
`10374
`3
`N
`10375
`3
`N
`16126
`1
`N
`21457
`1 BX
`N
`17559
`1
`N
`20503
`1 BX
`N
`20911
`2
`N
`20911
`1
`N
`20236
`1
`N
`21929
`1
`N
`21929
`2
`N
`19660
`1
`N
`18770
`1
`N
`17573
`1
`N
`20486
`1
`N
`18473
`1
`N
`20983
`1 BX
`N
`21730
`1
`N
`20587
`1
`N
`18584
`1
`N
`19798
`1
`N
`202813
`1
`N
`20233
`1
`N
`18521
`1
`N
`202129
`1
`N
`17351
`1
`N
`21780
`1
`A
`86457
`1 BX
`N
`19127
`1
`A
`89440
`1
`A
`86195
`1 BX
`N
`14242
`1
`N
`14394
`1
`N
`18705
`1
`
`Approval_Date
`
`Applicant_Full_Name
`RLD Type
`PERRIGO CO
`26‐Nov‐12 No RX
`PERRIGO UK FINCO LTD PARTNERSHIP
`31‐Mar‐10 No RX
`PERRIGO ISRAEL PHARMACEUTICALS LTD
`10‐Mar‐08 No RX
`PERRIGO ISRAEL PHARMACEUTICALS LTD
`14‐Aug‐12 No RX
`VELDANA MEDICAL SA
`24‐Oct‐13 Yes RX
`DELCOR ASSET CORP
`22‐Oct‐04 Yes RX
`DELCOR ASSET CORP
`12‐Jun‐07 Yes RX
`STIEFEL LABORATORIES INC
`11‐May‐12 Yes RX
`PERRIGO ISRAEL PHARMACEUTICALS LTD
`25‐Aug‐11 No RX
`DELCOR ASSET CORP
`28‐Feb‐99 Yes RX
`20‐Jan‐06 Yes OTC
`JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES
`PERRIGO ISRAEL PHARMACEUTICALS LTD
`28‐Apr‐11 No OTC
`DELCOR ASSET CORP
`26‐May‐00 Yes RX
`DELCOR ASSET CORP
`12‐Jan‐07 Yes RX
`STIEFEL LABORATORIES INC
`6‐Oct‐10 Yes RX
`AQUA PHARMACEUTICALS
`19‐Sep‐06 Yes RX
`JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES
`28‐Feb‐14 Yes OTC
`GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
`8‐Jun‐06 Yes RX
`GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
`8‐Jun‐06 Yes RX
`GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
`8‐Jun‐06 Yes RX
`17‐Aug‐84 No DISCN ROCHE PALO ALTO LLC
`27‐Jan‐06 Yes RX
`MEDA PHARMACEUTICALS INC
`14‐Aug‐96 No DISCN ARMSTRONG PHARMACEUTICALS INC
`19‐Aug‐97 No DISCN GENPHARM INC
`28‐Dec‐95 No DISCN IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
`1‐Aug‐96 No DISCN PLIVA INC
`Approved Prior to Jan 1, 1982
`No DISCN BOEHRINGER INGELHEIM PHARMACEUTICALS INC
`10‐Jan‐08 No RX
`TAKEDA GMBH
`10‐Jan‐08 Yes RX
`TAKEDA GMBH
`25‐Apr‐14 No RX
`MERCK SHARP AND DOHME CORP
`25‐Apr‐14 Yes RX
`MERCK SHARP AND DOHME CORP
`19‐Sep‐90 No DISCN UNITED STATES ARMY OFFICE SURGEON GENERAL
`29‐Dec‐86 No DISCN BOEHRINGER INGELHEIM PHARMACEUTICALS INC
`27‐Nov‐04 Yes RX
`BOEHRINGER INGELHEIM PHARMACEUTICALS INC
`23‐Apr‐82 No DISCN ABBVIE INC
`Approved Prior to Jan 1, 1982
`No DISCN GLAXOSMITHKLINE
`17‐Aug‐84 No DISCN NOVARTIS PHARMACEUTICALS CORP
`19‐Mar‐85 No DISCN SANOFI AVENTIS US LLC
`BLAIREX LABORATORIES INC
`3‐Sep‐92 Yes OTC
`Approved Prior to Jan 1, 1982
`No DISCN WYETH CONSUMER HEALTHCARE
`Approved Prior to Jan 1, 1982
`No DISCN STERLING HEALTH DIV STERLING WINTHROP INC
`Approved Prior to Jan 1, 1982
`No DISCN SANOFI AVENTIS US LLC
`24‐Oct‐96 Yes RX
`BOEHRINGER INGELHEIM PHARMACEUTICALS INC
`Approved Prior to Jan 1, 1982
`No DISCN UCB INC
`22‐Jun‐10 Yes RX
`MERCK SHARP AND DOHME CORP
`22‐Jun‐10 Yes RX
`MERCK SHARP AND DOHME CORP
`Approved Prior to Jan 1, 1982
`No DISCN 3M PHARMACEUTICALS INC
`23‐May‐84 No DISCN ARMSTRONG PHARMACEUTICALS INC
`27‐Mar‐96 No DISCN GLAXOSMITHKLINE
`27‐Mar‐96 No DISCN GLAXOSMITHKLINE
`27‐Mar‐96 No DISCN GLAXOSMITHKLINE
`14‐May‐04 Yes RX
`GLAXO GROUP LTD DBA GLAXOSMITHKLINE
`14‐May‐04 Yes RX
`GLAXO GROUP LTD DBA GLAXOSMITHKLINE
`14‐May‐04 Yes RX
`GLAXO GROUP LTD DBA GLAXOSMITHKLINE
`5‐Dec‐85 No DISCN KING PHARMACEUTICALS INC SUB PFIZER INC
`21‐Aug‐84 No DISCN ALPHARMA US PHARMACEUTICALS DIVISION
`Approved Prior to Jan 1, 1982
`No DISCN 3M PHARMACEUTICALS INC
`Approved Prior to Jan 1, 1982
`No DISCN ALPHARMA US PHARMACEUTICALS DIVISION
`Approved Prior to Jan 1, 1982
`No DISCN SANOFI AVENTIS US LLC
`30‐Nov‐92 Yes RX
`MEDICIS PHARMACEUTICAL CORP
`30‐Dec‐86 No DISCN VALEANT PHARMACEUTICAL NORTH AMERICA LLC
`Approved Prior to Jan 1, 1982
`No DISCN 3M PHARMACEUTICALS INC
`Approved Prior to Jan 1, 1982
`No DISCN 3M PHARMACEUTICALS INC
`Approved Prior to Jan 1, 1982
`No DISCN 3M PHARMACEUTICALS INC
`Approved Prior to Jan 1, 1982
`No DISCN WYETH CONSUMER HEALTHCARE
`29‐Oct‐04 Yes RX
`TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
`Approved Prior to Jan 1, 1982
`No DISCN SCHERING CORP SUB SCHERING PLOUGH CORP
`15‐Aug‐96 Yes RX
`3M PHARMACEUTICALS INC
`15‐Sep‐00 Yes RX
`TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
`15‐Sep‐00 Yes RX
`TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
`4‐Feb‐94 No DISCN GLAXOSMITHKLINE
`21‐Jul‐06 Yes RX
`ASTRAZENECA LP
`21‐Jul‐06 Yes RX
`ASTRAZENECA LP
`30‐Dec‐92 No DISCN KING PHARMACEUTICALS INC
`28‐Dec‐84 No DISCN SANOFI AVENTIS US LLC
`Approved Prior to Jan 1, 1982
`No DISCN SCHERING CORP SUB SCHERING PLOUGH CORP
`24‐Dec‐96 No DISCN SCHERING CORP
`No DISCN GLAXOSMITHKLINE
`Approved Prior to Jan 1, 1982
`19‐Apr‐01 Yes RX
`GLAXOSMITHKLINE INTELLECTUAL PROPERTY LTD ENGLAND
`11‐Mar‐05 Yes RX
`SUNOVION PHARMACEUTICALS INC
`24‐Dec‐97 Yes RX
`BRYAN CORP
`Approved Prior to Jan 1, 1982
`No DISCN GLAXOSMITHKLINE
`11‐Jul‐91 No DISCN SANOFI AVENTIS US LLC
`23‐Mar‐12 Yes RX
`TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
`14‐Feb‐94 No DISCN ASTRAZENECA LP
`Approved Prior to Jan 1, 1982
`No DISCN SCHERING CORP SUB SCHERING PLOUGH CORP
`20‐Jan‐12 Yes RX
`TAKEDA GMBH
`10‐Feb‐82 Yes RX
`MEDA PHARMACEUTICALS INC
`2‐Nov‐06 Yes RX
`MIST PHARMACEUTICALS LLC
`Approved Prior to Jan 1, 1982
`No RX
`MEDA PHARMACEUTICALS INC
`24‐Dec‐84 Yes OTC
`XTTRIUM LABORATORIES INC
`17‐May‐88 No DISCN VINTAGE PHARMACEUTICALS
`Approved Prior to Jan 1, 1982
`No RX
`MEDA PHARMACEUTICALS INC
`Approved Prior to Jan 1, 1982
`No DISCN UCB INC
`Approved Prior to Jan 1, 1982
`No DISCN ASTRAZENECA LP
`31‐Oct‐85 No DISCN POHL BOSKAMP
`
`A
`A
`
`83296
`85805
`
`2
`1
`
`Approved Prior to Jan 1, 1982
`Approved Prior to Jan 1, 1982
`
`No DISCN ALLERGAN HERBERT DIV ALLERGAN INC
`No DISCN ALLERGAN HERBERT DIV ALLERGAN INC
`
`Page 00003
`
`

`

`Ingredient
`
`DEXAMETHASONE
`BACITRACIN ZINC; POLYMYXIN B SULFATE
`PIPERONYL BUTOXIDE; PYRETHRINS
`HEXACHLOROPHENE
`HEXACHLOROPHENE
`NONOXYNOL‐9
`CHOLESTYRAMINE
`CHOLESTYRAMINE
`AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
`AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
`AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
`DOXYCYCLINE HYCLATE
`
`DF;Route
`
`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, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL
`CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL
`CAPSULE, COATED PELLETS;ORAL
`
`LANSOPRAZOLE; NAPROXEN
`LANSOPRAZOLE; NAPROXEN
`LANSOPRAZOLE; NAPROXEN
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DIVALPROEX SODIUM
`DIDANOSINE
`DIDANOSINE
`DIDANOSINE
`DIDANOSINE
`DIDANOSINE
`DIDANOSINE
`DIDANOSINE
`DIDANOSINE
`DIDANOSINE
`DIDANOSINE
`DIDANOSINE
`DIVALPROEX SODIUM
`DIVALPROEX SODIUM
`DIVALPROEX SODIUM
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`ERYTHROMYCIN
`ERYTHROMYCIN
`ERYTHROMYCIN
`ERYTHROMYCIN
`ERYTHROMYCIN
`ERYTHROMYCIN
`ERYTHROMYCIN
`ERYTHROMYCIN
`FLUOXETINE HYDROCHLORIDE
`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, TABLET;ORAL
`CAPSULE, DELAYED REL PELLETS, TABLET;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`
`Page 00004
`
`

`

`Trade_Name
`
`DECASPRAY
`POLYSPORIN
`RID MOUSSE
`SEPTISOL
`TURGEX
`DELFEN
`CHOLYBAR
`CHOLYBAR
`LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN
`LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN
`PREVPAC
`DOXYCYCLINE HYCLATE
`
`PREVACID NAPRAPAC 250 (COPACKAGED)
`PREVACID NAPRAPAC 375 (COPACKAGED)
`PREVACID NAPRAPAC 500 (COPACKAGED)
`CYMBALTA
`CYMBALTA
`CYMBALTA
`DEPAKOTE
`DIDANOSINE
`DIDANOSINE
`DIDANOSINE
`DIDANOSINE
`DIDANOSINE
`DIDANOSINE
`DIDANOSINE
`DIDANOSINE
`DIDANOSINE
`DIDANOSINE
`DIDANOSINE
`DIVALPROEX SODIUM
`DIVALPROEX SODIUM
`DIVALPROEX SODIUM
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`DULOXETINE HYDROCHLORIDE
`ERYC
`ERYC
`ERYC
`ERYC
`ERYC 125
`ERYC SPRINKLES
`ERYTHROMYCIN
`ERYTHROMYCIN
`FLUOXETINE HYDROCHLORIDE
`FLUOXETINE HYDROCHLORIDE
`LANSOPRAZOLE
`LANSOPRAZOLE
`LANSOPRAZOLE
`LANSOPRAZOLE
`LANSOPRAZOLE
`LANSOPRAZOLE
`LANSOPRAZOLE
`LANSOPRAZOLE
`LANSOPRAZOLE
`LANSOPRAZOLE
`LANSOPRAZOLE
`LANSOPRAZOLE
`LANSOPRAZOLE
`LANSOPRAZOLE
`LANSOPRAZOLE
`LANSOPRAZOLE
`LANSOPRAZOLE
`LANSOPRAZOLE
`
`Applicant
`
`MERCK
`GLAXOSMITHKLINE
`BAYER HEALTHCARE LLC
`VESTAL LABS
`XTTRIUM
`PERSONAL PRODS
`PARKE DAVIS
`PARKE DAVIS
`SANDOZ
`TEVA PHARMS USA
`TAKEDA PHARMS USA
`PLIVA
`
`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
`AUROBINDO PHARMA LTD
`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
`ZYDUS PHARMS USA INC
`ZYDUS PHARMS USA INC
`ZYDUS PHARMS USA INC
`ZYDUS PHARMS USA INC
`ZYDUS PHARMS USA INC
`ZYDUS PHARMS USA INC
`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
`0.04% **Federal Register determination that product was not discontinued or withdrawn for safety 
`or efficacy reasons**
`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
`500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG
`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 125MG VALPROIC ACID
`EQ 125MG VALPROIC ACID
`EQ 125MG VALPROIC ACID
`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 Appl_No Product_No TE_Code
`
`Approval_Date
`
`RLD Type
`
`Applicant_Full_Name
`
`N
`N
`N
`N
`N
`N
`A
`A
`A
`A
`N
`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
`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
`
`12731
`50167
`21043
`17424
`18375
`14349
`71621
`71739
`202588
`200218
`50757
`63187
`
`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
`2
`1
`1
`1
`2
`1
`1
`1 AB
`1 AB
`1 AB
`1
`
`2
`3
`4
`1 AB
`2 AB
`4 AB
`1 AB
`1 AB
`2 AB
`3 AB
`4 AB
`1 AB
`2 AB
`3 AB
`1 AB
`2 AB
`3 AB
`4 AB
`1 AB
`1 AB
`1 AB
`1 AB
`2 AB
`3 AB
`1 AB
`2 AB
`3 AB
`1 AB
`2 AB
`3 AB
`1 AB
`2 AB
`3 AB
`1 AB
`2 AB
`3 AB
`1 AB
`2 AB
`3 AB
`1 AB
`2 AB
`3
`4 AB
`1 AB
`2 AB
`3 AB
`1 AB
`2 AB
`3 AB
`1 AB
`2 AB
`3 AB
`1 AB
`1 AB
`2 AB
`2 AB
`3 AB
`3 AB
`1 AB
`1
`1
`1
`1
`1
`1 AB
`1
`1 AB
`1 AB
`1 AB
`1
`2 AB
`1 AB
`2 AB
`1 AB
`2 AB
`1
`1 AB
`2 AB
`1 AB
`1 AB
`1 AB
`2 AB
`1
`1 AB
`2 AB
`1 AB
`
`No DISCN MERCK AND CO INC
`Approved Prior to Jan 1, 1982
`1‐Mar‐85 No DISCN GLAXOSMITHKLINE
`7‐Mar‐00 Yes OTC
`BAYER HEALTHCARE LLC
`Approved Prior to Jan 1, 1982
`No DISCN VESTAL LABORATORIES DIV CHEMED CORP
`Approved Prior to Jan 1, 1982
`No DISCN XTTRIUM LABORATORIES INC
`Approved Prior to Jan 1, 1982
`No DISCN PERSONAL PRODUCTS CO
`26‐May‐88 No DISCN PARKE DAVIS DIV WARNER LAMBERT CO
`26‐May‐88 No DISCN PARKE DAVIS DIV WARNER LAMBERT CO
`4‐Mar‐14 No RX
`SANDOZ INC
`30‐Aug‐13 No RX
`TEVA PHARMACEUTICALS USA
`2‐Dec‐97 Yes RX
`TAKEDA PHARMACEUTICALS USA INC
`30‐Jun‐92 No DISCN PLIVA INC
`
`14‐Nov‐03 No DISCN TAKEDA PHARMACEUTICALS NORTH AMERICA INC
`14‐Nov‐03 No DISCN TAKEDA PHARMACEUTICALS NORTH AMERICA INC
`14‐Nov‐03 No DISCN TAKEDA PHARMACEUTICALS NORTH AMERICA INC
`3‐Aug‐04 No RX
`ELI LILLY AND CO
`3‐Aug‐04 No RX
`ELI LILLY AND CO
`3‐Aug‐04 Yes RX
`ELI LILLY AND CO
`12‐Sep‐89 Yes RX
`ABBVIE INC
`24‐Sep‐08 No RX
`AUROBINDO PHARMA LTD
`24‐Sep‐08 No RX
`AUROBINDO PHARMA LTD
`24‐Sep‐08 No RX
`AUROBINDO PHARMA LTD
`24‐Sep‐08 No RX
`AUROBINDO PHARMA LTD
`3‐Dec‐04 No RX
`BARR LABORATORIES INC
`3‐Dec‐04 No RX
`BARR LABORATORIES INC
`3‐Dec‐04 No RX
`BARR LABORATORIES INC
`8‐Apr‐10 No RX
`MYLAN PHARMACEUTICALS INC
`8‐Apr‐10 No RX
`MYLAN PHARMACEUTICALS INC
`8‐Apr‐10 No RX
`MYLAN PHARMACEUTICALS INC
`8‐Apr‐10 No RX
`MYLAN PHARMACEUTICALS INC
`23‐Jan‐09 No RX
`DR REDDYS LABORATORIES LTD
`28‐Mar‐11 No RX
`MYLAN PHARMACEUTICALS INC
`27‐Jan‐09 No RX
`ZYDUS PHARMACEUTICALS USA INC
`17‐Dec‐13 No RX
`ACTAVIS ELIZABETH LLC
`17‐Dec‐13 No RX
`ACTAVIS ELIZABETH LLC
`17‐Dec‐13 No RX
`ACTAVIS ELIZABETH LLC
`9‐Jun‐14 No RX
`ALEMBIC PHARMACEUTICALS LTD
`9‐Jun‐14 No RX
`ALEMBIC PHARMACEUTICALS LTD
`9‐Jun‐14 No RX
`ALEMBIC PHARMACEUTICALS LTD
`11‐Jun‐14 No RX
`APOTEX INC
`11‐Jun‐14 No RX
`APOTEX INC
`11‐Jun‐14 No RX
`APOTEX INC
`11‐Dec‐13 No RX
`AUROBINDO PHARMA LTD
`11‐Dec‐13 No RX
`AUROBINDO PHARMA LTD
`11‐Dec‐13 No RX
`AUROBINDO PHARMA LTD
`11‐Jun‐14 No RX
`BRECKENRIDGE PHARMACEUTICAL INC
`11‐Jun‐14 No RX
`BRECKENRIDGE PHARMACEUTICAL INC
`11‐Jun‐14 No RX
`BRECKENRIDGE PHARMACEUTICAL INC
`11‐Dec‐13 No RX
`DR REDDYS LABORATORIES LTD
`11‐Dec‐13 No RX
`DR REDDYS LABORATORIES LTD
`11‐Dec‐13 No RX
`DR REDDYS LABORATORIES LTD
`11‐Dec‐13 No RX
`LUPIN LTD
`11‐Dec‐13 No RX
`LUPIN LTD
`11‐Dec‐13 No RX
`LUPIN LTD
`11‐Dec‐13 No RX
`LUPIN LTD
`11‐Dec‐13 No RX
`SUN PHARMA GLOBAL FZE
`11‐Dec‐13 No RX
`SUN PHARMA GLOBAL FZE
`11‐Dec‐13 No RX
`SUN PHARMA GLOBAL FZE
`11‐Dec‐13 No RX
`TEVA PHARMACEUTICALS USA
`11‐Dec‐13 No RX
`TEVA PHARMACEUTICALS USA
`11‐Dec‐13 No RX
`TEVA PHARMACEUTICALS USA
`11‐Dec‐13 No RX
`TORRENT PHARMACEUTICALS LTD
`11‐Dec‐13 No RX
`TORRENT PHARMACEUTICALS LTD
`11‐Dec‐13 No RX
`TORRENT PHARMACEUTICALS LTD
`8‐Jan‐14 No RX
`ZYDUS PHARMACEUTICALS USA INC
`8‐Jan‐14 No RX
`ZYDUS PHARMACEUTICALS USA INC
`8‐Jan‐14 No RX
`ZYDUS PHARMACEUTICALS USA INC
`8‐Jan‐14 No RX
`ZYDUS PHARMACEUTICALS USA INC
`8‐Jan‐14 No RX
`ZYDUS PHARMACEUTICALS USA INC
`8‐Jan‐14 No RX
`ZYDUS PHARMACEUTICALS USA INC
`Approved Prior to Jan 1, 1982
`Yes RX
`MAYNE PHARMA INTERNATIONAL PTY LTD
`25‐Jul‐85 No DISCN PARKE DAVIS DIV WARNER LAMBERT CO
`25‐Sep‐85 No DISCN PARKE DAVIS DIV WARNER LAMBERT CO
`Approved Prior to Jan 1, 1982
`No DISCN WARNER CHILCOTT CO LLC
`24‐Oct‐85 No DISCN PARKE DAVIS DIV WARNER LAMBERT CO
`22‐Jul‐85 No DISCN HOSPIRA INC
`22‐Dec‐86 No RX
`ARBOR PHARMACEUTICALS LLC
`4‐May‐89 No DISCN BARR LABORATORIES INC
`24‐Mar‐10 No RX
`BARR LABORATORIES INC
`22‐Mar‐10 No RX
`DR REDDYS LABORATORIES LTD
`15‐Oct‐10 No RX
`DR REDDYS LABORATORIES LTD
`18‐May‐12 No OTC
`DR REDDYS LABORATORIES LTD
`15‐Oct‐10 No RX
`DR REDDYS LABORATORIES LTD
`10‐Nov‐09 No RX
`MYLAN PHARMACEUTICALS INC
`10‐Nov‐09 No RX
`MYLAN PHARMACEUTICALS INC
`18‐Dec‐12 No RX
`NATCO PHARMA LTD
`18‐Dec‐12 No RX
`NATCO PHARMA LTD
`18‐May‐12 No OTC
`PERRIGO R AND D CO
`23‐Apr‐10 No RX
`SANDOZ INC
`23‐Apr‐10 No RX
`SANDOZ INC
`13‐Sep‐13 No RX
`SUN PHARMA GLOBAL FZE
`13‐Sep‐13 No RX
`SUN PHARMA GLOBAL FZE
`10‐Nov‐09 No RX
`TEVA PHARMACEUTICALS USA
`10‐Nov‐09 No RX
`TEVA PHARMACEUTICALS USA
`18‐May‐12 No OTC WOCKHARDT LTD
`14‐Sep‐12 No RX
`WOCKHARDT USA LLC
`14‐Sep‐12 No RX
`WOCKHARDT USA LLC
`19‐Aug‐13 No RX
`ZYDUS HEALTHCARE USA LLC
`
`Page 00006
`
`

`

`Ingredient
`LANSOPRAZOLE
`LANSOPRAZOLE
`LANSOPRAZOLE
`ESOMEPRAZOLE MAGNESIUM
`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
`FLUOXETINE HYDROCHLORIDE
`DIDANOSINE
`DIDANOSINE
`DIDANOSINE
`DIDANOSINE
`RABEPRAZOLE SODIUM
`RABEPRAZOLE SODIUM
`PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
`PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
`PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
`PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
`PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
`MESALAMINE
`DEXLANSOPRAZOLE
`DEXLANSOPRAZOLE
`DOXYCYCLINE HYCLATE
`DOXYCYCLINE HYCLATE
`DOXYCYCLINE HYCLATE
`DOXYCYCLINE HYCLATE
`DOXYCYCLINE HYCLATE
`ESOMEPRAZOLE STRONTIUM
`ESOMEPRAZOLE STRONTIUM
`CHOLINE FENOFIBRATE
`CHOLINE FENOFIBRATE
`CHOLINE FENOFIBRATE
`CHOLINE FENOFIBRATE
`CHOLINE FENOFIBRATE
`CHOLINE FENOFIBRATE
`ESOMEPRAZOLE MAGNESIUM
`OMEPRAZOLE MAGNESIUM
`PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
`PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
`PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
`PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
`PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
`PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
`PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
`CYSTEAMINE BITARTRATE
`CYSTEAMINE BITARTRATE
`VALPROIC ACID
`VALPROIC ACID
`VALPROIC ACID
`DIMETHYL FUMARATE
`DIMETHYL FUMARATE
`CHOLINE FENOFIBRATE
`CHOLINE FENOFIBRATE
`PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
`PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
`PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
`PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
`PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
`PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
`PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
`PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
`PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
`PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
`ACETAZOLAMIDE
`ACETAZOLAMIDE
`PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
`AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; 
`DEXTROAMPHETAMINE SULFATE
`
`DF;Route
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELAYED REL PELLETS;ORAL
`CAPSULE, DELA