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FDA drug approvals in 2002

FDA approved the original submission of 92 new drug and biologics license applications in 2002, from 68 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 31, 2002	HUMIRA	adalimumab	ABBVIE INC	BLA125057
December 31, 2002	ZERIT XR	stavudine	BRISTOL MYERS SQUIBB	NDA021453
December 30, 2002	ZOVIRAX	acyclovir	BAUSCH	NDA021478
December 26, 2002	RELPAX	eletriptan hydrobromide	UPJOHN	NDA021016
December 24, 2002	FINACEA	azelaic acid	LEO PHARMA AS	NDA021470
December 23, 2002	RESTASIS MULTIDOSE	cyclosporine	ABBVIE	NDA050790
December 20, 2002	DEPAKOTE ER	divalproex sodium	ABBOTT	NDA020782
December 20, 2002	EXTRANEAL	icodextrin	VANTIVE US HLTHCARE	NDA021321
December 19, 2002	ADVIL ALLERGY SINUS	chlorpheniramine maleate, ibuprofen, pseudoephedrine hydrochloride	HALEON US HOLDINGS	NDA021441
December 19, 2002	ALAVERT	loratadine	FDN CONSUMER	NDA021375
December 19, 2002	BRAVELLE	urofollitropin	FERRING	BLA021484
December 19, 2002	METHYLIN	methylphenidate hydrochloride	SPECGX LLC	NDA021419
December 17, 2002	IDKIT:HP	citric acid, urea c-13	MERIDIAN BIOSCIENCE	NDA021314
December 13, 2002	CIPRO XR	ciprofloxacin, ciprofloxacin hydrochloride	BAYER HLTHCARE	NDA021473
December 4, 2002	CENTANY	mupirocin	PADAGIS US	NDA050788
December 3, 2002	COPEGUS	ribavirin	ROCHE	NDA021511
November 27, 2002	LEXAPRO	escitalopram oxalate	ABBVIE	NDA021365
November 26, 2002	FORTEO	teriparatide	LILLY	NDA021318
November 26, 2002	STRATTERA	atomoxetine hydrochloride	LILLY	NDA021411
November 22, 2002	ALINIA	nitazoxanide	ROMARK	NDA021498
November 15, 2002	ABILIFY	aripiprazole	OTSUKA	NDA021436
November 14, 2002	MITOZYTREX	mitomycin	SUPERGEN	NDA050763
November 8, 2002	ACIPHEX	rabeprazole sodium	EISAI MEDCL RES	NDA021456
October 31, 2002	NICORETTE	nicotine polacrilex	HALEON US HOLDINGS	NDA021330
October 31, 2002	TESTIM	testosterone	ENDO OPERATIONS	NDA021454
October 25, 2002	ZETIA	ezetimibe	ORGANON	NDA021445
October 24, 2002	THYRO-TABS	levothyroxine sodium	ALVOGEN	NDA021116
October 21, 2002	METAGLIP	glipizide, metformin hydrochloride	BRISTOL MYERS SQUIBB	NDA021460
October 18, 2002	MIDOL LIQUID GELS	ibuprofen	BIONPHARMA	NDA021472
October 17, 2002	DAYPRO ALTA	oxaprozin potassium	PFIZER	NDA020776
October 17, 2002	MENTAX-TC	butenafine hydrochloride	PHARMOBEDIENT	NDA021408
October 16, 2002	PEGASYS	peginterferon alfa-2a	Pharmaand GmbH	BLA103964
October 10, 2002	AVANDAMET	metformin hydrochloride, rosiglitazone maleate	SB PHARMCO	NDA021410
October 8, 2002	SUBOXONE	buprenorphine hydrochloride, naloxone hydrochloride	INDIVIOR	NDA020733
October 8, 2002	SUBUTEX	buprenorphine hydrochloride	INDIVIOR	NDA020732
October 7, 2002	CHLORAPREP TRIPLE SWABSTICK	chlorhexidine gluconate, isopropyl alcohol	BECTON DICKINSON CO	NDA021555
September 27, 2002	INSPRA	eplerenone	UPJOHN	NDA021437
September 25, 2002	AUGMENTIN XR	amoxicillin, clavulanate potassium	US ANTIBIOTICS	NDA050785
September 20, 2002	HEPSERA	adefovir dipivoxil	GILEAD	NDA021449
September 20, 2002	ULTRAVIST (PHARMACY BULK)	iopromide	BAYER HLTHCARE	NDA021425
September 16, 2002	MINIRIN	desmopressin acetate	FERRING	NDA021333
August 30, 2002	PREVACID	lansoprazole	TAKEDA PHARMS USA	NDA021428
August 29, 2002	LEXAPRO	escitalopram oxalate	FOREST LABS	NDA021440
August 29, 2002	ZANAFLEX	tizanidine hydrochloride	LEGACY	NDA021447
August 26, 2002	DUAC	benzoyl peroxide, clindamycin phosphate	STIEFEL	NDA050741
August 22, 2002	ORTHO TRI-CYCLEN LO	ethinyl estradiol, norgestimate	JANSSEN PHARMS	NDA021241
August 14, 2002	LEXAPRO	escitalopram oxalate	ABBVIE	NDA021323
August 9, 2002	ELOXATIN	oxaliplatin	SANOFI AVENTIS US	NDA021492
July 26, 2002	SINGULAIR	montelukast sodium	ORGANON	NDA021409
July 24, 2002	ELIGARD KIT	leuprolide acetate	TOLMAR	NDA021379
July 24, 2002	SYNTHROID	levothyroxine sodium	ABBVIE	NDA021402
July 24, 2002	ZELNORM	tegaserod maleate	ALFASIGMA	NDA021200
July 17, 2002	XYREM	sodium oxybate	JAZZ PHARMS	NDA021196
July 12, 2002	ELITEK	rasburicase	SANOFI SYNTHELABO	BLA103946
July 12, 2002	MUCINEX	guaifenesin	RECKITT BENCKISER	NDA021282
June 26, 2002	ALTOPREV	lovastatin	AZURITY	NDA021316
June 26, 2002	CLARINEX	desloratadine	ORGANON	NDA021312
June 21, 2002	GEODON	ziprasidone mesylate	VIATRIS	NDA020919
June 11, 2002	CAVERJECT IMPULSE	alprostadil	PFIZER	NDA021212
June 5, 2002	RITALIN LA	methylphenidate hydrochloride	SANDOZ	NDA021284
May 31, 2002	EUTHYROX	levothyroxine sodium	EMD SERONO INC	NDA021292
May 31, 2002	IMAGENT	dimyristoyl lecithin, perflexane	VESSELON SPV LLC	NDA021191
May 30, 2002	ADVIL COLD AND SINUS	ibuprofen, pseudoephedrine hydrochloride	HALEON US HOLDINGS	NDA021374
May 24, 2002	NEURONTIN	gabapentin	PARKE DAVIS	NDA021397
May 24, 2002	NEURONTIN	gabapentin	PARKE DAVIS	NDA021423
May 24, 2002	NEURONTIN	gabapentin	PARKE DAVIS	NDA021424
May 24, 2002	VFEND	voriconazole	PF PRISM CV	NDA021266
May 24, 2002	VFEND	voriconazole	PF PRISM CV	NDA021267
May 24, 2002	ZITHROMAX	azithromycin	PFIZER	NDA050784
May 21, 2002	REMODULIN	treprostinil	UNITED THERAP	NDA021272
May 6, 2002	BRAVELLE	urofollitropin	FERRING	BLA021289
April 25, 2002	BENICAR	olmesartan medoxomil	COSETTE	NDA021286
April 25, 2002	FASLODEX	fulvestrant	ASTRAZENECA	NDA021344
April 18, 2002	CHILDREN'S ADVIL COLD	ibuprofen, pseudoephedrine hydrochloride	HALEON US HOLDINGS	NDA021373
April 5, 2002	ALORA	estradiol	WATSON LABS	NDA021310
April 4, 2002	PORCINE SECRETIN	porcine secretin	CHIRHOCLIN	NDA021209
April 4, 2002	SECREFLO	secretin synthetic porcine	CHIRHOCLIN	NDA021136
March 21, 2002	MESNEX	mesna	BAXTER HLTHCARE	NDA020855
March 20, 2002	AVINZA	morphine sulfate	KING PHARMS LLC	NDA021260
March 7, 2002	REBIF	interferon beta-1a	SERONO INC	BLA103780
March 4, 2002	PAMIDRONATE DISODIUM	pamidronate disodium	HIKMA	NDA021113
March 1, 2002	LEVO-T	levothyroxine sodium	CEDIPROF INC	NDA021342
February 22, 2002	ZOMETA	zoledronic acid	NOVARTIS	NDA021386
February 19, 2002	ZEVALIN	ibritumomab tiuxetan	SPECTRUM PHARMS	BLA125019
February 8, 2002	CLARINEX	desloratadine	SCHERING	NDA021297
February 8, 2002	CLARINEX	desloratadine	SCHERING	NDA021363
February 1, 2002	SUSTIVA	efavirenz	BRISTOL MYERS SQUIBB	NDA021360
January 31, 2002	NEULASTA	pegfilgrastim	AMGEN	BLA125031
January 23, 2002	ELIGARD KIT	leuprolide acetate	TOLMAR	NDA021343
January 18, 2002	ORFADIN	nitisinone	SWEDISH ORPHAN	NDA021232
January 18, 2002	TRI-LUMA	fluocinolone acetonide, hydroquinone, tretinoin	GALDERMA LABS LP	NDA021112
January 17, 2002	ATNAA	atropine, pralidoxime chloride	US ARMY	NDA021175