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FDA drug approvals in 2011

FDA approved the original submission of 84 new drug and biologics license applications in 2011, from 66 sponsors. FDA marks 29 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 21, 2011	ADVIL ALLERGY AND CONGESTION RELIEF	chlorpheniramine maleate, ibuprofen, phenylephrine hydrochloride	HALEON US HOLDINGS	NDA022113
December 21, 2011	ISENTRESS	raltegravir potassium	MSD SUB MERCK	NDA203045
December 20, 2011	EDARBYCLOR	azilsartan kamedoxomil, chlorthalidone	AZURITY	NDA202331
December 16, 2011	PREZISTA	darunavir	JANSSEN PRODS	NDA202895
December 9, 2011	OPANA ER	oxymorphone hydrochloride	ENDO PHARMS	NDA201655
December 7, 2011	GELNIQUE 3%	oxybutynin	ALLERGAN	NDA202513
December 1, 2011	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	HOSPIRA INC	NDA200403
November 23, 2011	INTERMEZZO	zolpidem tartrate	PURDUE PHARMA	NDA022328
November 18, 2011	EYLEA	aflibercept	REGENERON PHARMACEUTICALS	BLA125387
November 16, 2011	JAKAFI	ruxolitinib phosphate	INCYTE CORP	NDA202192
November 14, 2011	MORPHINE SULFATE	morphine sulfate	HOSPIRA INC	NDA202515
November 10, 2011	FORFIVO XL	bupropion hydrochloride	TWI PHARMS	NDA022497
November 9, 2011	LEVETIRACETAM IN SODIUM CHLORIDE	levetiracetam	HQ SPCLT PHARMA	NDA202543
November 4, 2011	XARELTO	rivaroxaban	JANSSEN PHARMS	NDA202439
October 28, 2011	EXPAREL	bupivacaine	PACIRA PHARMS INC	NDA022496
October 21, 2011	ONFI	clobazam	LUNDBECK PHARMS LLC	NDA202067
October 14, 2011	FERRIPROX	deferiprone	CHIESI	NDA021825
October 7, 2011	COMBIVENT RESPIMAT	albuterol sulfate, ipratropium bromide	BOEHRINGER INGELHEIM	NDA021747
October 7, 2011	JUVISYNC	simvastatin, sitagliptin phosphate	MERCK SHARP DOHME	NDA202343
October 6, 2011	FLUOXETINE HYDROCHLORIDE	fluoxetine hydrochloride	TWI PHARMS	NDA202133
September 1, 2011	PUR-WASH	purified water	NIAGARA PHARMS	NDA022305
August 26, 2011	XALKORI	crizotinib	PF PRISM CV	NDA202570
August 25, 2011	FIRAZYR	icatibant acetate	TAKEDA PHARMS USA	NDA022150
August 25, 2011	NUCYNTA ER	tapentadol hydrochloride	COLLEGIUM PHARM INC	NDA200533
August 19, 2011	ADCETRIS	brentuximab vedotin	SEATTLE GENETICS	BLA125388
August 19, 2011	ADCETRIS	brentuximab vedotin	SEATTLE GENETICS	BLA125399
August 17, 2011	ZELBORAF	vemurafenib	HOFFMANN LA ROCHE	NDA202429
August 10, 2011	COMPLERA	emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate	GILEAD SCIENCES INC	NDA202123
August 4, 2011	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	HOSPIRA INC	NDA200795
July 21, 2011	HEPARIN SODIUM	heparin sodium	PFIZER	NDA201370
July 20, 2011	BRILINTA	ticagrelor	ASTRAZENECA	NDA022433
July 1, 2011	ARCAPTA NEOHALER	indacaterol maleate	NOVARTIS	NDA022383
July 1, 2011	XARELTO	rivaroxaban	JANSSEN PHARMS	NDA022406
June 30, 2011	CODEINE SULFATE	codeine sulfate	HIKMA	NDA202245
June 30, 2011	LAZANDA	fentanyl citrate	BTCP PHARMA	NDA022569
June 29, 2011	ARGATROBAN IN SODIUM CHLORIDE	argatroban	CIPLA	NDA022434
June 29, 2011	DOCETAXEL	docetaxel	SANDOZ	NDA201525
June 24, 2011	LEVOTHYROXINE SODIUM	levothyroxine sodium	FRESENIUS KABI USA	NDA202231
June 23, 2011	MORPHINE SULFATE	morphine sulfate	CHARTWELL MOLECULAR	NDA201517
June 21, 2011	RECTIV	nitroglycerin	ABBVIE	NDA021359
June 17, 2011	OXAYDO	oxycodone hydrochloride	ZYLA	NDA202080
June 15, 2011	NULOJIX	belatacept	BRISTOL MYERS SQUIBB	BLA125288
June 13, 2011	CEFTAZIDIME IN DEXTROSE CONTAINER	ceftazidime	B BRAUN	NDA050823
June 13, 2011	SUPRENZA	phentermine hydrochloride	CITIUS PHARMS	NDA202088
June 10, 2011	POTIGA	ezogabine	GLAXOSMITHKLINE	NDA022345
June 8, 2011	DOCETAXEL	docetaxel	ACCORD HLTHCARE	NDA201195
June 8, 2011	REZIRA	hydrocodone bitartrate, pseudoephedrine hydrochloride	PERSION	NDA022442
June 8, 2011	ZUTRIPRO	chlorpheniramine maleate, hydrocodone bitartrate, pseudoephedrine hydrochloride	PERSION	NDA022439
May 27, 2011	DIFICID	fidaxomicin	CUBIST PHARMS LLC	NDA201699
May 23, 2011	INCIVEK	telaprevir	VERTEX PHARMS	NDA201917
May 20, 2011	EDURANT	rilpivirine hydrochloride	JANSSEN PRODS	NDA202022
May 13, 2011	VICTRELIS	boceprevir	MERCK SHARP DOHME	NDA202258
May 9, 2011	ARGATROBAN IN DEXTROSE	argatroban	SANDOZ	NDA201743
May 9, 2011	ARGATROBAN IN SODIUM CHLORIDE	argatroban	PLANO PHARMS	NDA022485
May 3, 2011	DOCETAXEL	docetaxel	SUN PHARM	NDA022534
May 2, 2011	TRADJENTA	linagliptin	BOEHRINGER INGELHEIM	NDA201280
April 29, 2011	ANDROGEL	testosterone	BESINS HLTHCARE	NDA022309
April 28, 2011	ZYTIGA	abiraterone acetate	JANSSEN BIOTECH	NDA202379
April 23, 2011	DUEXIS	famotidine, ibuprofen	HORIZON	NDA022519
April 18, 2011	PHOSLYRA	calcium acetate	FRESENIUS MEDCL CARE	NDA022581
April 15, 2011	LOTEMAX	loteprednol etabonate	BAUSCH AND LOMB	NDA200738
April 6, 2011	CAPRELSA	vandetanib	GENZYME CORP	NDA022405
April 6, 2011	HORIZANT	gabapentin enacarbil	AZURITY	NDA022399
March 25, 2011	VIRAMUNE XR	nevirapine	BOEHRINGER INGELHEIM	NDA201152
March 25, 2011	YERVOY	ipilimumab	BRISTOL MYERS SQUIBB	BLA125377
March 24, 2011	ZYCLARA	imiquimod	GRACEWAY	NDA201153
March 14, 2011	GADAVIST	gadobutrol	BAYER HLTHCARE	NDA201277
March 9, 2011	BENLYSTA	belimumab	HUMAN GENOME SCIENCES INC.	BLA125370
March 8, 2011	DOCETAXEL	docetaxel	HOSPIRA INC	NDA022234
March 3, 2011	BANZEL	rufinamide	EISAI INC	NDA201367
February 28, 2011	DALIRESP	roflumilast	ASTRAZENECA	NDA022522
February 25, 2011	EDARBI	azilsartan kamedoxomil	AZURITY	NDA200796
February 25, 2011	TOPOTECAN	topotecan hydrochloride	SANDOZ INC	NDA200199
February 23, 2011	ZIDOVUDINE	zidovudine	PHARMOBEDIENT	NDA200732
February 8, 2011	OMECLAMOX-PAK	amoxicillin, clarithromycin, omeprazole	CUMBERLAND	NDA050824
February 2, 2011	TOPOTECAN HYDROCHLORIDE	topotecan hydrochloride	HOSPIRA INC	NDA200582
January 28, 2011	GRALISE	gabapentin	ALMATICA	NDA022544
January 26, 2011	SODIUM FLUORIDE F 18	sodium fluoride f-18	NIH NCI DCTD	NDA022494
January 24, 2011	CHILDREN'S ALLEGRA HIVES	fexofenadine hydrochloride	CHATTEM SANOFI	NDA201373
January 21, 2011	VIIBRYD	vilazodone hydrochloride	ABBVIE	NDA022567
January 18, 2011	NATROBA	spinosad	CIPHER	NDA022408
January 14, 2011	DATSCAN	ioflupane i-123	GE HLTHCARE INC	NDA022454
January 14, 2011	NITHIODOTE	sodium nitrite, sodium thiosulfate	HOPE PHARMS	NDA201444
January 7, 2011	ABSTRAL	fentanyl citrate	SENTYNL THERAPS INC	NDA022510