Drug Name and FDA Appl. |
Active Ingredients |
Company |
Approval Type |
KEMADRIN
(NDA # 009818) |
PROCYCLIDINE
HYDROCHLORIDE
|
MONARCH
PHARMS
|
Labelling
Revision
|
INFASURF
PRESERVATIVE FREE
(NDA # 020521) |
CALFACTANT
|
ONY
|
Labelling
Revision
|
FOSAMAX
(NDA # 020560) |
ALENDRONATE
SODIUM
|
MERCK
AND CO INC
|
Labelling
Revision
|
BUTRANS
(NDA # 021306) |
BUPRENORPHINE
|
PURDUE
PHARMA LP
|
Labeling
Revision
|
BUTRANS
(NDA # 021306) |
BUPRENORPHINE
|
PURDUE
PHARMA LP
|
Labeling
Revision
|
BONIVA
(NDA # 021455) |
IBANDRONATE
SODIUM
|
ROCHE
|
Labeling
Revision
|
FOSAMAX
(NDA # 021575) |
ALENDRONATE
SODIUM
|
MERCK
|
Labeling
Revision
|
FOSAMAX
PLUS D
(NDA # 021762) |
ALENDRONATE
SODIUM; CHOLECALCIFEROL
|
MERCK
|
Labeling
Revision
|
BONIVA
(NDA # 021858) |
IBANDRONATE
SODIUM
|
ROCHE
|
Labeling
Revision
|
ARCAPTA
(NDA # 022383) |
INDACATEROL
MALEATE
|
NOVARTIS
PHARMS
|
Approval
|
XARELTO
(NDA # 022406) |
RIVAROXABAN
|
JOHNSON
AND JOHNSON
|
Approval
|
GILENYA
(NDA # 022527) |
FINGOLIMOD
|
NOVARTIS
|
Labeling
Revision
|
ZOLPIDEM
TARTRATE
(ANDA # 090107) |
ZOLPIDEM
TARTRATE
|
SANDOZ
|
Approval
|
PREGABALIN
(ANDA # 091040) |
PREGABALIN
|
LUPIN
LTD
|
Tentative
Approval
|
VANCOMYCIN
HYDROCHLORIDE
(ANDA # 091469) |
VANCOMYCIN
HYDROCHLORIDE
|
PFIZER
|
Approval
|
AMLODIPINE
BESYLATE AND BENAZEPRIL HYDROCHLORIDE
(ANDA # 077179) |
AMLODIPINE
BESYLATE; BENAZEPRIL HYDROCHLORIDE
|
TEVA
PHARMS
|
Approval
|
AMLODIPINE
BESYLATE AND BENAZEPRIL HYDROCHLORIDE
(ANDA # 077179) |
AMLODIPINE
BESYLATE; BENAZEPRIL HYDROCHLORIDE
|
TEVA
PHARMS
|
Approval
|
AMLODIPINE
BESYLATE AND BENAZEPRIL HYDROCHLORIDE
(ANDA # 078466) |
AMLODIPINE
BESYLATE; BENAZEPRIL HYDROCHLORIDE
|
LUPIN
PHARMS
|
Approval
|
AMLODIPINE
BESYLATE; BENAZEPRIL HYDROCHLORIDE
(ANDA # 078466) |
AMLODIPINE
BESYLATE; BENAZEPRIL HYDROCHLORIDE
|
LUPIN
PHARMS
|
Approval
|
AMLODIPINE
BESYLATE AND BENAZEPRIL HYDROCHLORIDE
(ANDA # 079047) |
AMLODIPINE
BESYLATE; BENAZEPRIL HYDROCHLORIDE
|
MYLAN
|
Approval
|
AMLODIPINE
BESYLATE AND BENAZEPRIL HYDROCHLORIDE
(ANDA # 090149) |
AMLODIPINE
BESYLATE; BENAZEPRIL HYDROCHLORIDE
|
DR
REDDYS LABS INC
|
Approval
|
AMLODIPINE
BESYLATE AND BENAZEPRIL HYDROCHLORIDE
(ANDA # 090364) |
AMLODIPINE
BESYLATE; BENAZEPRIL HYDROCHLORIDE
|
WATSON
LABS INC
|
Approval
|
FELBATOL
(NDA # 020189) |
FELBAMATE
|
MEDA
PHARMS
|
Labeling
Revision
|
CARVEDILOL
|
SMITHKLINE
BEECHAM
|
Labeling
Revision
|
|
MICARDIS
(NDA # 020850) |
TELMISARTAN
|
BOEHRINGER
INGELHEIM
|
Labeling
Revision
|
HALFLYTELY
(NDA # 021551) |
BISACODYL;
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM
CHLORIDE
|
BRAINTREE
|
Labeling
Revision
|
XENAZINE
(NDA # 021894) |
TETRABENAZINE
|
VALEANT
INTL
|
Labeling
Revision
|
COREG
CR
(NDA # 022012) |
CARVEDILOL
PHOSPHATE
|
SB
PHARMCO
|
Labeling
Revision
|
SUPREP
BOWEL PREP KIT
(NDA # 022372) |
MAGNESIUM
SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE
|
BRAINTREE
LABS
|
Labeling
Revision
|
DULOXETINE
HYDROCHLORIDE
(ANDA # 090773) |
DULOXETINE
HYDROCHLORIDE
|
WOCKHARDT
|
Tentative
Approval
|
ZOFRAN
(NDA # 020007) |
ONDANSETRON
HYDROCHLORIDE
|
GLAXOSMITHKLINE
|
Labeling
Revision
|
ZOFRAN
PRESERVATIVE FREE
(NDA # 020007) |
ONDANSETRON
HYDROCHLORIDE
|
GLAXOSMITHKLINE
|
Labeling
Revision
|
ZOFRAN
AND DEXTROSE IN PLASTIC CONTAINER
(NDA # 020403) |
ONDANSETRON
HYDROCHLORIDE
|
GLAXOSMITHKLINE
|
Labeling
Revision
|
LEVOFLOXACIN
IN DEXTROSE 5% IN PLASTIC CONTAINER
(ANDA # 090343) |
LEVOFLOXACIN
|
ACS
DOBFAR INFO SA
|
Approval
|
CEVIMELINE
HYDROCHLORIDE
(ANDA # 091591) |
CEVIMELINE
HYDROCHLORIDE
|
ROXANE
|
Tentative
Approval
|
PAXIL
(NDA # 020031) |
PAROXETINE
HYDROCHLORIDE
|
GLAXOSMITHKLINE
|
Labeling
Revision
|
PAXIL
(NDA # 020031) |
PAROXETINE
HYDROCHLORIDE
|
GLAXOSMITHKLINE
|
Labeling
Revision
|
SEROQUEL
(NDA # 020639) |
QUETIAPINE
FUMARATE
|
ASTRAZENECA
|
Labeling
Revision
|
SEROQUEL
(NDA # 020639) |
QUETIAPINE
FUMARATE
|
ASTRAZENECA
|
Labeling
Revision
|
PAXIL
(NDA # 020710) |
PAROXETINE
HYDROCHLORIDE
|
GLAXOSMITHKLINE
|
Labeling
Revision
|
PAXIL
(NDA # 020710) |
PAROXETINE
HYDROCHLORIDE
|
GLAXOSMITHKLINE
|
Labeling
Revision
|
ARAVA
(NDA # 020905) |
LEFLUNOMIDE
|
SANOFI
AVENTIS US
|
Labeling
Revision
|
PAXIL
CR
(NDA # 020936) |
PAROXETINE
HYDROCHLORIDE
|
GLAXOSMITHKLINE
|
Labeling
Revision
|
PAXIL
CR
(NDA # 020936) |
PAROXETINE
HYDROCHLORIDE
|
GLAXOSMITHKLINE
|
Labeling
Revision
|
CARDURA
XL
(NDA # 021269) |
DOXAZOSIN
MESYLATE
|
PFIZER
|
Labeling
Revision
|
TRUVADA
(NDA # 021752) |
EMTRICITABINE;
TENOFOVIR DISOPROXIL FUMARATE
|
GILEAD
|
Labeling
Revision
|
SEROQUEL
XR
(NDA # 022047) |
QUETIAPINE
FUMARATE
|
ASTRAZENECA
|
Labeling
Revision
|
SEROQUEL
XR
(NDA # 022047) |
QUETIAPINE
FUMARATE
|
ASTRAZENECA
|
Labeling
Revision
|
CLONIDINE
HYDROCHLORIDE
(ANDA # 200673) |
CLONIDINE
HYDROCHLORIDE
|
APP
PHARMS
|
Approval
|
TIKOSYN
(NDA # 020931) |
DOFETILIDE
|
PFIZER
|
Approval
|
RAPAMUNE
(NDA # 021083) |
SIROLIMUS
|
WYETH
PHARMS INC
|
Labeling
Revision
|
RAPAMUNE
(NDA # 021110) |
SIROLIMUS
|
WYETH
PHARMS INC
|
Labeling
Revision
|
RANEXA
(NDA # 021526) |
RANOLAZINE
|
GILEAD
|
Labeling
Revision
|
VENLAFAXINE
HYDROCHLORIDE
(ANDA # 091123) |
VENLAFAXINE
HYDROCHLORIDE
|
ORCHID
HLTHCARE
|
Approval
|
CREON
(NDA # 020725) |
PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE)
|
ABBOTT
PRODS
|
Efficacy
Supplement with Clinical Data to Support
|
URSODIOL
(ANDA # 090801) |
URSODIOL
|
GLENMARK
GENERICS
|
Approval
|
DEXAMETHASONE
(ANDA # 090891) |
DEXAMETHASONE
|
LYNE
|
Approval
|
ZENPEP
(NDA # 022210) |
PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE)
|
EURAND
|
Manufacturing
Change or Addition
|
AZITHROMYCIN
(ANDA # 065507) |
AZITHROMYCIN
|
APOTEX
CORP
|
Approval
|
AZITHROMYCIN
(ANDA # 065508) |
AZITHROMYCIN
|
APOTEX
CORP
|
Approval
|
AZITHROMYCIN
(ANDA # 065509) |
AZITHROMYCIN
|
APOTEX
CORP
|
Approval
|
LETROZOLE
(ANDA # 090292) |
LETROZOLE
|
AMIDE
PHARM
|
Approval
|
PENNSAID
(NDA # 020947) |
DICLOFENAC
SODIUM
|
MALLINCKRODT
|
Labeling
Revision
|
PENNSAID
(NDA # 020947) |
DICLOFENAC
SODIUM
|
MALLINCKRODT
|
Labeling
Revision
|
BROVANA
(NDA # 021912) |
ARFORMOTEROL
TARTRATE
|
SUNOVION
|
Labeling
Revision
|
LIALDA
(NDA # 022000) |
MESALAMINE
|
SHIRE
|
Efficacy
Supplement with Clinical Data to Support
|
CAMBIA
(NDA # 022165) |
DICLOFENAC
POTASSIUM
|
NAUTILUS
NEUROSCIENC
|
Labeling
Revision
|
PROGRAF
(NDA # 050708) |
TACROLIMUS
|
ASTELLAS
|
Labeling
Revision
|
PROGRAF
(NDA # 050708) |
TACROLIMUS
|
ASTELLAS
|
Labeling
Revision
|
TACROLIMUS
|
ASTELLAS
|
Labeling
Revision
|
|
PROGRAF
(NDA # 050709) |
TACROLIMUS
|
ASTELLAS
|
Labeling
Revision
|
ACETAZOLAMIDE
(ANDA # 090779) |
ACETAZOLAMIDE
|
INDICUS
PHARMA
|
Approval
|
LEVETIRACETAM
(ANDA # 091093) |
LEVETIRACETAM
|
WATSON
LABS INC
|
Tentative
Approval
|
ESZOPICLONE
(ANDA # 091165) |
ESZOPICLONE
|
WOCKHARDT
LTD
|
Approval
|
KENALOG-10
(NDA # 012041) |
TRIAMCINOLONE
ACETONIDE
|
APOTHECON
|
Labeling
Revision
|
KENALOG-40
(NDA # 014901) |
TRIAMCINOLONE
ACETONIDE
|
APOTHECON
|
Labeling
Revision
|
TOPAMAX
(NDA # 020505) |
TOPIRAMATE
|
ORTHO
MCNEIL JANSSEN
|
Efficacy
Supplement with Clinical Data to Support
|
TOPAMAX
(NDA # 020844) |
TOPIRAMATE
|
ORTHO
MCNEIL JANSSEN
|
Efficacy
Supplement with Clinical Data to Support
|
TOPAMAX
SPRINKLE
(NDA # 020844) |
TOPIRAMATE
|
ORTHO
MCNEIL JANSSEN
|
Efficacy
Supplement with Clinical Data to Support
|
IMIQUIMOD
|
GRACEWAY
|
Efficacy
Supplement with Clinical Data to Support
|
|
PROPRANOLOL
HYDROCHLORIDE
(ANDA # 078703) |
PROPRANOLOL
HYDROCHLORIDE
|
GLAXOSMITHKLINE
|
Approval
|
NIZATIDINE
|
GLENMARK
GENERICS
|
Approval
|
|
DULOXETINE
HYDROCHLORIDE
(ANDA # 090723) |
DULOXETINE
HYDROCHLORIDE
|
DR
REDDYS LABS LTD
|
Tentative
Approval
|
ANASTROZOLE
(ANDA # 091177) |
ANASTROZOLE
|
SUN
PHARM INDS LTD
|
Approval
|
MORPHINE
SULFATE
(ANDA # 202348) |
MORPHINE
SULFATE
|
MALLINCKRODT
INC
|
Approval
|
DOSTINEX
(NDA # 020664) |
CABERGOLINE
|
PHARMACIA
AND UPJOHN
|
Labeling
Revision
|
WELCHOL
(NDA # 021176) |
COLESEVELAM
HYDROCHLORIDE
|
DAIICHI
SANKYO
|
Labeling
Revision
|
WELCHOL
(NDA # 022362) |
COLESEVELAM
HYDROCHLORIDE
|
DAIICHI
SANKYO
|
Labeling
Revision
|
METHYLPREDNISOLONE
SODIUM SUCCINATE
(ANDA # 040888) |
METHYLPREDNISOLONE
SODIUM SUCCINATE
|
MUSTAFA
NEVSAT
|
Approval
|
ALFUZOSIN
HYDROCHLORIDE
(ANDA # 079013) |
ALFUZOSIN
HYDROCHLORIDE
|
APOTEX
INC
|
Approval
|
ALFUZOSIN
HYDROCHLORIDE
(ANDA # 079014) |
ALFUZOSIN
HYDROCHLORIDE
|
MYLAN
|
Approval
|
ALFUZOSIN
HYDROCHLORIDE
|
TORRENT
PHARMS
|
Approval
|
|
ALFUZOSIN
HYDROCHLORIDE
(ANDA # 079056) |
ALFUZOSIN
HYDROCHLORIDE
|
TEVA
PHARMS
|
Approval
|
ALFUZOSIN
HYDROCHLORIDE
(ANDA # 079057) |
ALFUZOSIN
HYDROCHLORIDE
|
SUN
PHARMA GLOBAL
|
Approval
|
DIETHYLPROPION
HYDROCHLORIDE
(NDA # 200177) |
DIETHYLPROPION
HYDROCHLORIDE
|
LANNETT
HOLDINGS INC
|
Approval
|
TRANXENE
(NDA # 017105) |
CLORAZEPATE
DIPOTASSIUM
|
LUNDBECK
INC
|
Labeling
Revision
|
TRANXENE
SD
(NDA # 017105) |
CLORAZEPATE
DIPOTASSIUM
|
LUNDBECK
INC
|
Labeling
Revision
|
BIO-TROPIN
(NDA # 019774) |
SOMATROPIN
RECOMBINANT
|
FERRING
|
Labeling
Revision
|
TEV-TROPIN
(NDA # 019774) |
SOMATROPIN
RECOMBINANT
|
FERRING
|
Labeling
Revision
|
AMBRISENTAN
|
GILEAD
|
Labeling
Revision
|
|
HYDROCODONE
BITARTRATE AND ACETAMINOPHEN
(ANDA # 040894) |
ACETAMINOPHEN;
HYDROCODONE BITARTRATE
|
BOCA
PHARMA
|
Approval
|
LATANOPROST
(ANDA # 090887) |
LATANOPROST
|
PADDOCK
LABS
|
Approval
|
BRILINTA
(NDA # 022433) |
TICAGRELOR
|
ASTRAZENECA
LP
|
Approval
|
Tuesday 7 February 2012
FDA Approved Drugs July 2011
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