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FDA drug approvals in 2003

FDA approved the original submission of 82 new drug and biologics license applications in 2003, from 67 sponsors. FDA marks 32 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 24, 2003	SYMBYAX	fluoxetine hydrochloride, olanzapine	LILLY	NDA021520
December 19, 2003	ORAQIX	lidocaine, prilocaine	DENTSPLY PHARM	NDA021451
December 19, 2003	VFEND	voriconazole	PF PRISM CV	NDA021630
December 15, 2003	TALC	talc	SCIARRA LABS	NDA021388
December 10, 2003	ERTACZO	sertaconazole nitrate	LACER PHARMA	NDA021385
December 1, 2003	ZORBTIVE	somatropin recombinant	EMD SERONO	BLA021597
November 25, 2003	PLENAXIS	abarelix	SPECIALITY EUROPEAN	NDA021320
November 21, 2003	CIALIS	tadalafil	LILLY	NDA021368
November 21, 2003	CLIMARA PRO	estradiol, levonorgestrel	BAYER HLTHCARE	NDA021258
November 14, 2003	FEMCON FE	ethinyl estradiol, norethindrone	APIL	NDA021490
November 14, 2003	PREVACID NAPRAPAC 375 (COPACKAGED)	lansoprazole, naproxen	TAKEDA PHARMS NA	NDA021507
November 14, 2003	VFEND	voriconazole	PFIZER	NDA021464
November 14, 2003	VFEND	voriconazole	PFIZER	NDA021466
October 31, 2003	AMVAZ	amlodipine maleate	DR REDDYS LABS INC	NDA021435
October 30, 2003	KEMSTRO	baclofen	UCB INC	NDA021589
October 29, 2003	RISPERDAL CONSTA	risperidone	JANSSEN PHARMS	NDA021346
October 20, 2003	LEXIVA	fosamprenavir calcium	VIIV HLTHCARE	NDA021548
October 16, 2003	ELESTAT	epinastine hydrochloride	ALLERGAN	NDA021565
October 16, 2003	NAMENDA	memantine hydrochloride	ABBVIE	NDA021487
October 10, 2003	RESTASIS	cyclosporine	ALLERGAN	NDA021023
October 9, 2003	ESTRASORB	estradiol hemihydrate	EXELTIS USA INC	NDA021371
October 9, 2003	PROHANCE MULTIPACK	gadoteridol	BRACCO	NDA021489
October 2, 2003	RADIOGARDASE (PRUSSIAN BLUE)	ferric hexacyanoferrate(ii)	HEYL CHEMISCH	NDA021626
September 30, 2003	ZOMIG	zolmitriptan	AMNEAL	NDA021450
September 17, 2003	FOSAMAX	alendronate sodium	MERCK	NDA021575
September 12, 2003	CUBICIN	daptomycin	CUBIST PHARMS LLC	NDA021572
September 11, 2003	RIOMET	metformin hydrochloride	RANBAXY	NDA021591
September 5, 2003	SEASONALE	ethinyl estradiol, levonorgestrel	TEVA BRANDED PHARM	NDA021544
September 4, 2003	RYTHMOL SR	propafenone hydrochloride	GLAXOSMITHKLINE LLC	NDA021416
August 28, 2003	CIPRO XR	ciprofloxacin, ciprofloxacin hydrochloride	BAYER PHARMS	NDA021554
August 28, 2003	WELLBUTRIN XL	bupropion hydrochloride	BAUSCH	NDA021515
August 19, 2003	LEVITRA	vardenafil hydrochloride	BAYER HLTHCARE	NDA021400
August 12, 2003	CRESTOR	rosuvastatin calcium	ASTRAZENECA	NDA021366
August 1, 2003	PHOTOFRIN	porfimer sodium	AXCAN SCANDIPHARM	NDA021525
July 31, 2003	ZAVESCA	miglustat	ACTELION	NDA021348
July 29, 2003	REBETOL	ribavirin	SCHERING	NDA021546
July 25, 2003	ALOXI	palonosetron hydrochloride	HELSINN HLTHCARE	NDA021372
July 24, 2003	CLOBEX	clobetasol propionate	GALDERMA LABS LP	NDA021535
July 18, 2003	CIPRODEX	ciprofloxacin, dexamethasone	SANDOZ	NDA021537
July 16, 2003	PREMARIN	estrogens, conjugated	WYETH PHARMS INC	NDA021417
July 15, 2003	KEPPRA	levetiracetam	UCB INC	NDA021505
July 14, 2003	PARAPLATIN	carboplatin	CORDENPHARMA	NDA020452
July 3, 2003	PEXEVA	paroxetine mesylate	SEBELA IRELAND LTD	NDA021299
July 2, 2003	EMTRIVA	emtricitabine	GILEAD	NDA021500
June 24, 2003	PRAVIGARD PAC (COPACKAGED)	aspirin, pravastatin sodium	BRISTOL MYERS SQUIBB	NDA021387
June 20, 2003	PRILOSEC OTC	omeprazole magnesium	ASTRAZENECA	NDA021229
June 20, 2003	REYATAZ	atazanavir sulfate	BRISTOL MYERS SQUIBB	NDA021567
June 20, 2003	XOLAIR	omalizumab	GENENTECH	BLA103976
June 19, 2003	STRIANT	testosterone	AUXILIUM PHARMS LLC	NDA021543
June 12, 2003	UROXATRAL	alfuzosin hydrochloride	ADVANZ PHARMA	NDA021287
June 11, 2003	STALEVO 75	carbidopa, entacapone, levodopa	ORION PHARMA	NDA021485
June 6, 2003	LEVOLET	levothyroxine sodium	GENUS LIFESCIENCES	NDA021137
June 5, 2003	BENICAR HCT	hydrochlorothiazide, olmesartan medoxomil	COSETTE	NDA021532
June 4, 2003	PREMPRO/PREMPHASE	conjugated estrogens/medroxyprogesterone acetate	WYETH AYERST	NDA021396
May 30, 2003	ACULAR LS	ketorolac tromethamine	ABBVIE	NDA021528
May 30, 2003	ADRENACLICK	epinephrine	IMPAX	NDA020800
May 23, 2003	DUOCAINE	bupivacaine hydrochloride, lidocaine hydrochloride	AMPHASTAR PHARMS INC	NDA021496
May 16, 2003	BONIVA	ibandronate sodium	HOFFMANN LA ROCHE	NDA021455
May 13, 2003	VELCADE	bortezomib	TAKEDA PHARMS USA	NDA021602
May 5, 2003	IRESSA	gefitinib	ASTRAZENECA	NDA021399
April 30, 2003	ALDURAZYME	laronidase	BIOMARIN	BLA125058
April 30, 2003	VIRACEPT	nelfinavir mesylate	AGOURON PHARMS	NDA021503
April 24, 2003	FABRAZYME	agalsidase beta	GENZYME	BLA103979
April 18, 2003	GLEEVEC	imatinib mesylate	NOVARTIS	NDA021588
April 15, 2003	METHYLIN	methylphenidate hydrochloride	SPECGX LLC	NDA021475
April 15, 2003	VIGAMOX	moxifloxacin hydrochloride	HARROW EYE	NDA021598
April 4, 2003	FACTIVE	gemifloxacin mesylate	LG CHEM LTD	NDA021158
April 4, 2003	IPRIVASK	desirudin recombinant	BAUSCH	BLA021271
April 2, 2003	RISPERDAL	risperidone	JANSSEN PHARMS	NDA021444
March 28, 2003	ZYMAR	gatifloxacin	ALLERGAN	NDA021493
March 26, 2003	EMEND	aprepitant	MSD	NDA021549
March 25, 2003	SOMAVERT	pegvisomant	PHARMACIA	BLA021106
March 20, 2003	FEMRING	estradiol acetate	MILLICENT MFG PR	NDA021367
March 13, 2003	FUZEON	enfuvirtide	ROCHE	NDA021481
March 12, 2003	INNOPRAN XL	propranolol hydrochloride	ANI PHARMS	NDA021438
February 28, 2003	LOPROX	ciclopirox	BAUSCH	NDA021159
February 26, 2003	OXYTROL	oxybutynin	ALLERGAN	NDA021351
February 13, 2003	ELIGARD KIT	leuprolide acetate	TOLMAR	NDA021488
February 6, 2003	CARDIZEM LA	diltiazem hydrochloride	BAUSCH	NDA021392
February 5, 2003	PYRIDOSTIGMINE BROMIDE	pyridostigmine bromide	US ARMY	NDA020414
January 24, 2003	HICON	sodium iodide i-131	JUBILANT	NDA021305
January 17, 2003	XANAX XR	alprazolam	UPJOHN	NDA021434