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FDA drug approvals in 2008

FDA approved the original submission of 85 new drug and biologics license applications in 2008, from 64 sponsors. FDA marks 31 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 30, 2008	RYZOLT	tramadol hydrochloride	PURDUE PHARMA	NDA021745
December 24, 2008	FIRMAGON	degarelix acetate	FERRING	NDA022201
December 24, 2008	LATISSE	bimatoprost	ABBVIE	NDA022369
December 24, 2008	NEXTERONE	amiodarone hydrochloride	BAXTER HLTHCARE	NDA022325
December 22, 2008	ABLAVAR	gadofosveset trisodium	LANTHEUS MEDCL	NDA021711
December 19, 2008	CASODEX	bicalutamide	ASTRAZENECA	NDA022310
December 19, 2008	ZOLPIMIST	zolpidem tartrate	AYTU	NDA022196
December 18, 2008	OFORTA	fludarabine phosphate	SANOFI AVENTIS US	NDA022273
December 15, 2008	MOZOBIL	plerixafor	GENZYME	NDA022311
December 15, 2008	TRILIPIX	choline fenofibrate	ABBVIE	NDA022224
December 8, 2008	EPIDUO	adapalene, benzoyl peroxide	GALDERMA LABS LP	NDA022320
December 8, 2008	LUSEDRA	fospropofol disodium	EISAI INC	NDA022244
December 5, 2008	ARIMIDEX	anastrozole	ASTRAZENECA	NDA022214
November 28, 2008	SYNTHETIC CONJUGATED ESTROGENS A	estrogens, conjugated synthetic a	TEVA WOMENS	NDA021788
November 20, 2008	NUCYNTA	tapentadol hydrochloride	COLLEGIUM PHARM INC	NDA022304
November 20, 2008	PROMACTA	eltrombopag olamine	NOVARTIS	NDA022291
November 14, 2008	BANZEL	rufinamide	EISAI INC	NDA021911
October 31, 2008	APRISO	mesalamine	SALIX	NDA022301
October 31, 2008	TOVIAZ	fesoterodine fumarate	PFIZER	NDA022030
October 31, 2008	TREANDA	bendamustine hydrochloride	CEPHALON	NDA022303
October 28, 2008	VIMPAT	lacosamide	UCB INC	NDA022253
October 28, 2008	VIMPAT	lacosamide	UCB INC	NDA022254
October 24, 2008	LOSEASONIQUE	ethinyl estradiol, levonorgestrel	TEVA BRANDED PHARM	NDA022262
October 23, 2008	ACANYA	benzoyl peroxide, clindamycin phosphate	BAUSCH	NDA050819
October 15, 2008	ASTEPRO	azelastine hydrochloride	VIATRIS	NDA022203
October 8, 2008	RAPAFLO	silodosin	ABBVIE	NDA022206
October 7, 2008	AKTEN	lidocaine hydrochloride	THEA PHARMA	NDA022221
September 19, 2008	ADREVIEW	iobenguane sulfate i-123	GE HEALTHCARE	NDA022290
September 12, 2008	KEPPRA XR	levetiracetam	UCB INC	NDA022285
September 12, 2008	SANCUSO	granisetron	APOTEX	NDA022198
August 26, 2008	NOVOLOG MIX 50/50	insulin aspart protamine recombinant, insulin aspart recombinant	NOVO NORDISK INC	BLA021810
August 22, 2008	ALOXI	palonosetron hydrochloride	HELSINN HLTHCARE	NDA022233
August 22, 2008	NPLATE	romiplostim	AMGEN	BLA125268
August 15, 2008	XENAZINE	tetrabenazine	BAUSCH	NDA021894
August 8, 2008	AK-FLUOR 25%	fluorescein sodium	LONG GROVE PHARMS	NDA022186
August 5, 2008	CEFEPIME IN PLASTIC CONTAINER	cefepime hydrochloride	BAXTER HLTHCARE	NDA050817
August 1, 2008	CLEVIPREX	clevidipine	CHIESI	NDA022156
July 29, 2008	STAVZOR	valproic acid	BIONPHARMA	NDA022152
July 24, 2008	NAVSTEL	calcium chloride, dextrose, magnesium chloride, oxiglutatione, potassium chloride, sodium bicarbonate, sodium chloride, sodium phosphate	ALCON PHARMS LTD	NDA022193
July 24, 2008	NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	nicardipine hydrochloride	HIKMA INTL PHARMS	NDA022276
July 3, 2008	EOVIST	gadoxetate disodium	BAYER HLTHCARE	NDA022090
June 27, 2008	VELETRI	epoprostenol sodium	ACTELION	NDA022260
June 23, 2008	APTIVUS	tipranavir	BOEHRINGER INGELHEIM	NDA021822
June 23, 2008	APTIVUS	tipranavir	BOEHRINGER INGELHEIM	NDA022292
June 23, 2008	DUREZOL	difluprednate	SANDOZ	NDA022212
June 23, 2008	PRANDIMET	metformin hydrochloride, repaglinide	NOVO NORDISK INC	NDA022386
June 16, 2008	CLARITIN	loratadine	BAYER HEALTHCARE LLC	NDA021952
June 16, 2008	TRIVARIS	triamcinolone acetonide	ALLERGAN	NDA022220
June 13, 2008	CYMBALTA	duloxetine hydrochloride	LILLY	NDA022148
June 13, 2008	REQUIP XL	ropinirole hydrochloride	GLAXOSMITHKLINE LLC	NDA022008
May 29, 2008	ASACOL HD	mesalamine	ABBVIE	NDA021830
May 20, 2008	ENTEREG	alvimopan	CUBIST PHARMS	NDA021775
May 20, 2008	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	OSMOTICA PHARM US	NDA022104
May 9, 2008	ORAVERSE	phentolamine mesylate	SEPTODONT HOLDING	NDA022159
May 9, 2008	TACLONEX	betamethasone dipropionate, calcipotriene, calcipotriene hydrate	LEO PHARMA AS	NDA022185
May 8, 2008	DESMOPRESSIN ACETATE	desmopressin acetate	FERRING	NDA021795
May 7, 2008	UROLOGIC G IN PLASTIC CONTAINER	citric acid, magnesium oxide, sodium carbonate	HOSPIRA	NDA018904
April 24, 2008	RELISTOR	methylnaltrexone bromide	SALIX PHARMS	NDA021964
April 23, 2008	APLENZIN	bupropion hydrobromide	BAUSCH	NDA022108
April 22, 2008	CIMZIA	certolizumab pegol	UCB INC	BLA125160
April 15, 2008	PATANASE	olopatadine hydrochloride	NOVARTIS	NDA021861
April 15, 2008	TREXIMET	naproxen sodium, sumatriptan succinate	AZURITY	NDA021926
April 14, 2008	LUVOX	fluvoxamine maleate	JAZZ	NDA022235
April 10, 2008	LEXISCAN	regadenoson	ASTELLAS	NDA022161
March 31, 2008	ANTHELIOS 40	avobenzone, ecamsule, octocrylene, titanium dioxide	LOREAL USA	NDA022009
March 24, 2008	DEPAKOTE ER	divalproex sodium	ABBVIE INC	NDA022267
March 20, 2008	PRILOSEC	omeprazole magnesium	AZURITY	NDA022056
March 20, 2008	TREANDA	bendamustine hydrochloride	CEPHALON	NDA022249
March 17, 2008	MORPHINE SULFATE	morphine sulfate	HIKMA	NDA022195
March 17, 2008	MORPHINE SULFATE	morphine sulfate	HIKMA	NDA022207
March 7, 2008	FUSILEV	levoleucovorin calcium	ACROTECH BIOPHARMA	NDA020140
February 29, 2008	PRISTIQ	desvenlafaxine succinate	PF PRISM CV	NDA021992
February 28, 2008	LUVOX CR	fluvoxamine maleate	JAZZ PHARMS	NDA022033
February 27, 2008	ARCALYST	rilonacept	KINIKSA PHARMACEUTICALS (UK), LTD.	BLA125249
February 27, 2008	NEXIUM	esomeprazole magnesium	ASTRAZENECA	NDA022101
February 21, 2008	COSYNTROPIN	cosyntropin	SANDOZ	NDA022028
February 20, 2008	SALONPAS	menthol, methyl salicylate	HISAMITSU PHARM CO	NDA022029
January 28, 2008	XYZAL	levocetirizine dihydrochloride	CHATTEM SANOFI	NDA022157
January 25, 2008	EMEND	fosaprepitant dimeglumine	MERCK AND CO INC	NDA022023
January 23, 2008	ACCRETROPIN	somatropin	EMERGENT	BLA021538
January 23, 2008	MOXATAG	amoxicillin	PRAGMA	NDA050813
January 18, 2008	INTELENCE	etravirine	JANSSEN R AND D	NDA022187
January 18, 2008	TEKTURNA HCT	aliskiren hemifumarate, hydrochlorothiazide	NODEN PHARMA	NDA022107
January 17, 2008	FLO-PRED	prednisolone acetate	SUN PHARMA CANADA	NDA022067
January 10, 2008	ALVESCO	ciclesonide	AZURITY	NDA021658