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FDA drug approvals in 2009

FDA approved the original submission of 90 new drug and biologics license applications in 2009, from 62 sponsors. FDA marks 24 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 11, 2009	ZYPREXA RELPREVV	olanzapine pamoate	CHEPLAPHARM	NDA022173
December 4, 2009	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide, omeprazole, sodium bicarbonate	SANTARUS	NDA022456
December 3, 2009	CLONIDINE	clonidine	TRIS PHARMA INC	NDA022499
December 3, 2009	NEXICLON XR	clonidine	ROSEMOUNT	NDA022500
December 1, 2009	KALBITOR	ecallantide	DYAX CORP.	BLA125277
December 1, 2009	ZEGERID OTC	omeprazole, sodium bicarbonate	RILEY CONSUMER	NDA022281
November 25, 2009	NEXCEDE	ketoprofen	NOVARTIS	NDA022470
November 18, 2009	REVATIO	sildenafil citrate	VIATRIS	NDA022473
November 17, 2009	NICARDIPINE HYDROCHLORIDE	nicardipine hydrochloride	SUN PHARM	NDA078405
November 16, 2009	QUTENZA	capsaicin	AVERITAS	NDA022395
November 13, 2009	LYSTEDA	tranexamic acid	J MOLNER	NDA022430
November 5, 2009	ISTODAX	romidepsin	BRISTOL-MYERS	NDA022393
November 4, 2009	PENNSAID	diclofenac sodium	NUVO PHARMS INC	NDA020947
October 30, 2009	BYETTA	exenatide synthetic	AMYLIN	NDA021919
October 26, 2009	KESIMPTA	ofatumumab	NOVARTIS	BLA125326
October 19, 2009	VOTRIENT	pazopanib hydrochloride	NOVARTIS	NDA022465
October 16, 2009	COLCRYS	colchicine	AR HOLDING CO INC	NDA022353
October 16, 2009	TWYNSTA	amlodipine besylate, telmisartan	BOEHRINGER INGELHEIM	NDA022401
October 2, 2009	WELCHOL	colesevelam hydrochloride	COSETTE	NDA022362
September 29, 2009	KAPVAY	clonidine hydrochloride	CONCORDIA PHARMS INC	NDA022331
September 25, 2009	STELARA	ustekinumab	CENTOCOR ORTHO BIOTECH INC	BLA125261
September 24, 2009	FOLOTYN	pralatrexate	ACROTECH BIOPHARMA	NDA022468
September 16, 2009	VALTURNA	aliskiren hemifumarate, valsartan	NOVARTIS	NDA022217
September 15, 2009	ZIRGAN	ganciclovir	BAUSCH AND LOMB	NDA022211
September 11, 2009	VIBATIV	telavancin hydrochloride	APOTEX	NDA022110
September 8, 2009	BEPREVE	bepotastine besilate	BAUSCH AND LOMB INC	NDA022288
September 4, 2009	METOZOLV ODT	metoclopramide hydrochloride	SALIX PHARMS	NDA022246
September 2, 2009	INTUNIV	guanfacine hydrochloride	TAKEDA PHARMS USA	NDA022037
August 31, 2009	ASTEPRO	azelastine hydrochrloride	MEDA PHARMS	NDA022371
August 28, 2009	VALCYTE	valganciclovir hydrochloride	CHEPLAPHARM	NDA022257
August 27, 2009	ZENPEP	pancrelipase (amylase, lipase, protease)	EURAND PHARMA LTD	BLA022210
August 21, 2009	SABRIL	vigabatrin	LUNDBECK PHARMS LLC	NDA020427
August 21, 2009	SABRIL	vigabatrin	LUNDBECK PHARMS LLC	NDA022006
August 14, 2009	FIBRICOR	fenofibric acid	ROSEMOUNT	NDA022418
August 13, 2009	EMBEDA	morphine sulfate, naltrexone hydrochloride	ALPHARMA PHARMS	NDA022321
August 13, 2009	SAPHRIS	asenapine maleate	ABBVIE	NDA022117
August 12, 2009	RENVELA	sevelamer carbonate	GENZYME	NDA022318
August 7, 2009	OXALIPLATIN	oxaliplatin	TEVA PHARMS	NDA022160
August 3, 2009	LIVALO	pitavastatin calcium	KOWA CO	NDA022363
July 31, 2009	INVEGA SUSTENNA	paliperidone palmitate	JANSSEN PHARMS	NDA022264
July 31, 2009	ONGLYZA	saxagliptin hydrochloride	ASTRAZENECA AB	NDA022350
July 31, 2009	XERESE	acyclovir, hydrocortisone	BAUSCH	NDA022436
July 30, 2009	COLCRYS	colchicine	AR HOLDING CO INC	NDA022351
July 30, 2009	TYVASO	treprostinil	UNITED THERAP	NDA022387
July 29, 2009	COLCRYS	colchicine	TAKEDA PHARMS USA	NDA022352
July 23, 2009	CETIRIZINE HYDROCHLORIDE ALLERGY	cetirizine hydrochloride	BIONPHARMA	NDA022429
July 23, 2009	ZIDOVUDINE	zidovudine	AUROBINDO PHARMA	NDA022294
July 22, 2009	ACUVAIL	ketorolac tromethamine	ABBVIE	NDA022427
July 16, 2009	CODEINE SULFATE	codeine sulfate	HIKMA	NDA022402
July 16, 2009	ONSOLIS	fentanyl citrate	ADALVO	NDA022266
July 15, 2009	SUMAVEL DOSEPRO	sumatriptan succinate	ENDO OPERATIONS	NDA022239
July 10, 2009	EFFIENT	prasugrel hydrochloride	COSETTE	NDA022307
July 10, 2009	PLAN B ONE-STEP	levonorgestrel	FDN CONSUMER	NDA021998
July 2, 2009	SOTALOL HYDROCHLORIDE	sotalol hydrochloride	ALTATHERA PHARMS LLC	NDA022306
July 1, 2009	MULTAQ	dronedarone hydrochloride	SANOFI AVENTIS US	NDA022425
June 30, 2009	FERAHEME	ferumoxytol	AZURITY	NDA022180
June 17, 2009	CAMBIA	diclofenac potassium	COSETTE	NDA022165
June 17, 2009	ILARIS	canakinumab	NOVARTIS PHARMS	BLA125319
June 17, 2009	OZURDEX	dexamethasone	ABBVIE	NDA022315
June 16, 2009	ZIPSOR	diclofenac potassium	COSETTE	NDA022202
June 11, 2009	CALDOLOR	ibuprofen	APOTEX	NDA022348
May 29, 2009	LAMICTAL XR	lamotrigine	GLAXOSMITHKLINE LLC	NDA022115
May 28, 2009	BESIVANCE	besifloxacin hydrochloride	BAUSCH AND LOMB	NDA022308
May 22, 2009	ADCIRCA	tadalafil	ELI LILLY CO	NDA022332
May 19, 2009	SAMSCA	tolvaptan	OTSUKA	NDA022275
May 18, 2009	NICORETTE	nicotine polacrilex	HALEON US HOLDINGS	NDA022360
May 18, 2009	PREVACID 24 HR	lansoprazole	PERRIGO PHARMA INTL	NDA022327
May 12, 2009	ACTOPLUS MET XR	metformin hydrochloride, pioglitazone hydrochloride	TAKEDA PHARMS USA	NDA022024
May 8, 2009	LAMICTAL ODT	lamotrigine	GLAXOSMITHKLINE LLC	NDA022251
May 6, 2009	FANAPT	iloperidone	VANDA PHARMS INC	NDA022192
May 5, 2009	CYCLOSET	bromocriptine mesylate	VEROSCIENCE	NDA020866
May 1, 2009	CETRAXAL	ciprofloxacin hydrochloride	LAB SALVAT	NDA021918
April 30, 2009	CREON	pancrelipase (amylase, lipase, protease)	ABBVIE	BLA020725
April 30, 2009	EXFORGE HCT	amlodipine besylate, hydrochlorothiazide, valsartan	NOVARTIS	NDA022314
April 29, 2009	DYSPORT	abobotulinumtoxina	IPSEN BIOPHARM LTD	BLA125274
April 28, 2009	TYZEKA	telbivudine	NOVARTIS	NDA022154
April 24, 2009	SIMPONI	golimumab	CENTOCOR ORTHO BIOTECH INC	BLA125289
April 9, 2009	ULESFIA	benzyl alcohol	SHIONOGI	NDA022129
April 7, 2009	COARTEM	artemether, lumefantrine	NOVARTIS	NDA022268
March 30, 2009	AFINITOR	everolimus	NOVARTIS	NDA022334
March 13, 2009	EDLUAR	zolpidem tartrate	VIATRIS	NDA021997
March 13, 2009	MYCIFRADIN	neomycin sulfate	PHARMACIA AND UPJOHN	NDA050285
February 27, 2009	TEMODAR	temozolomide	MERCK SHARP DOHME	NDA022277
February 20, 2009	MEMBRANEBLUE	trypan blue	DORC	NDA022278
February 13, 2009	TOBRADEX ST	dexamethasone, tobramycin	HARROW EYE	NDA050818
February 13, 2009	ULORIC	febuxostat	TAKEDA PHARMS USA	NDA021856
January 30, 2009	DEXILANT	dexlansoprazole	TAKEDA PHARMS USA	NDA022287
January 27, 2009	GELNIQUE	oxybutynin chloride	ABBVIE	NDA022204
January 23, 2009	VECTICAL	calcitriol	GALDERMA LABS LP	NDA022087
January 14, 2009	SAVELLA	milnacipran hydrochloride	ABBVIE	NDA022256