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FDA drug approvals in 1996

FDA approved the original submission of 144 new drug and biologics license applications in 1996, from 94 sponsors. FDA marks 79 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 31, 1996	MENTAX	butenafine hydrochloride	MYLAN BERTEK	NDA020663
December 30, 1996	DEPACON	valproate sodium	ABBVIE	NDA020593
December 27, 1996	LEXXEL	enalapril maleate, felodipine	ASTRAZENECA	NDA020668
December 27, 1996	MICROZIDE	hydrochlorothiazide	TEVA BRANDED PHARM	NDA020504
December 24, 1996	ORGARAN	danaparoid sodium	ASPEN GLOBAL INC	NDA020430
December 24, 1996	TOPAMAX	topiramate	JANSSEN PHARMS	NDA020505
December 24, 1996	VANCERIL DOUBLE STRENGTH	beclomethasone dipropionate	SCHERING	NDA020486
December 23, 1996	CLARITIN HIVES RELIEF REDITAB	loratadine	BAYER HEALTHCARE LLC	NDA020704
December 23, 1996	DIOVAN	valsartan	NOVARTIS	NDA020665
December 23, 1996	DOSTINEX	cabergoline	PFIZER	NDA020664
December 23, 1996	KLARON	sulfacetamide sodium	BAUSCH	NDA019931
December 20, 1996	ALORA	estradiol	ABBVIE	NDA020655
December 20, 1996	COPAXONE	glatiramer acetate	TEVA PHARMS USA	NDA020622
December 20, 1996	LEVAQUIN	levofloxacin	JANSSEN PHARMS	NDA020634
December 20, 1996	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	JANSSEN PHARMS	NDA020635
December 19, 1996	MONUROL	fosfomycin tromethamine	ZAMBON SPA	NDA050717
December 19, 1996	ZAGAM	sparfloxacin	MYLAN	NDA020677
December 18, 1996	GLYSET	miglitol	PFIZER	NDA020682
December 18, 1996	PATADAY TWICE DAILY RELIEF	olopatadine hydrochloride	ALCON LABS INC	NDA020688
December 17, 1996	APHTHASOL	amlexanox	ULURU	NDA020511
December 17, 1996	LIPITOR	atorvastatin calcium	UPJOHN	NDA020702
December 13, 1996	JUNIOR STRENGTH ADVIL	ibuprofen	HALEON US HOLDINGS	NDA020267
December 9, 1996	COTAZYM	pancrelipase (amylase, lipase, protease)	ORGANON USA INC	BLA020580
December 9, 1996	ZYFLO	zileuton	CHIESI	NDA020471
December 6, 1996	GASTROMARK	ferumoxsil	AMAG PHARMS INC	NDA020410
December 6, 1996	SPORANOX	itraconazole	JANSSEN PHARMA	NDA020694
December 3, 1996	FEMPATCH	estradiol	PARKE DAVIS	NDA020417
November 27, 1996	ZANAFLEX	tizanidine hydrochloride	LEGACY	NDA020397
November 25, 1996	ARICEPT	donepezil hydrochloride	EISAI INC	NDA020690
November 22, 1996	AMPHOTEC	amphotericin b	ALKOPHARMA USA	NDA050729
November 22, 1996	STROMECTOL	ivermectin	MERCK SHARP DOHME	NDA050742
November 19, 1996	MUSE	alprostadil	VIATRIS	NDA020700
November 15, 1996	JUNIOR STRENGTH MOTRIN	ibuprofen	KENVUE BRANDS	NDA020601
November 5, 1996	NASCOBAL	cyanocobalamin	ENDO OPERATIONS	NDA019722
November 1, 1996	ASTELIN	azelastine hydrochloride	RISING	NDA020114
November 1, 1996	JADELLE	levonorgestrel	POPULATION COUNCIL	NDA020544
October 28, 1996	PROSTASCINT	capromab pendetide	CYTOGEN	BLA103608
October 28, 1996	SORIATANE	acitretin	STIEFEL LABS INC	NDA019821
October 25, 1996	CYSTADANE	betaine	RECORDATI RARE	NDA020576
October 25, 1996	LODINE XL	etodolac	WYETH PHARMS INC	NDA020584
October 24, 1996	COMBIVENT	albuterol sulfate, ipratropium bromide	BOEHRINGER INGELHEIM	NDA020291
October 22, 1996	TARKA	trandolapril, verapamil hydrochloride	ABBVIE	NDA020591
October 18, 1996	MENTAX	butenafine hydrochloride	PHARMOBEDIENT	NDA020524
October 17, 1996	AZULFIDINE	sulfasalazine	PHARMACIA AND UPJOHN	NDA020465
October 10, 1996	CLARITIN HIVES RELIEF	loratadine	BAYER HEALTHCARE LLC	NDA020641
October 9, 1996	ESTROSTEP 21	ethinyl estradiol, norethindrone acetate	APIL	NDA020130
October 8, 1996	SAIZEN	somatropin	EMD SERONO	BLA019764
October 4, 1996	TECZEM	diltiazem malate, enalapril maleate	BIOVAIL	NDA020507
October 4, 1996	TIAMATE	diltiazem malate	MERCK	NDA020506
October 4, 1996	WELLBUTRIN SR	bupropion hydrochloride	GLAXOSMITHKLINE	NDA020358
October 2, 1996	DURACLON	clonidine hydrochloride	MYLAN INSTITUTIONAL	NDA020615
September 30, 1996	ZYPREXA	olanzapine	CHEPLAPHARM	NDA020592
September 27, 1996	ELLIOTTS B SOLUTION	calcium chloride, dextrose, magnesium sulfate, potassium chloride, sodium bicarbonate, sodium chloride, sodium phosphate, dibasic, heptahydrate	LUKARE MEDICAL LLC	NDA020577
September 27, 1996	ZYRTEC	cetirizine hydrochloride	J AND J CONSUMER INC	NDA020346
September 26, 1996	ACCOLATE	zafirlukast	STRIDES PHARMA INTL	NDA020547
September 26, 1996	ELMIRON	pentosan polysulfate sodium	JANSSEN PHARMS	NDA020193
September 24, 1996	DENAVIR	penciclovir	MYLAN	NDA020629
September 24, 1996	NAROPIN	ropivacaine hydrochloride	FRESENIUS KABI USA	NDA020533
September 23, 1996	GLIADEL	carmustine	AZURITY	NDA020637
September 19, 1996	NILANDRON	nilutamide	ADVANZ PHARMA	NDA020169
September 17, 1996	MERETEK UBT KIT (W/ PRANACTIN)	urea c-13	OTSUKA AMERICA	NDA020586
September 6, 1996	ALPHAGAN	brimonidine tartrate	ALLERGAN	NDA020613
September 6, 1996	PROAMATINE	midodrine hydrochloride	TAKEDA PHARMS USA	NDA019815
September 6, 1996	ZERIT	stavudine	BRISTOL	NDA020413
August 30, 1996	FERIDEX I.V.	ferumoxides	AMAG PHARMS INC	NDA020416
August 29, 1996	LAC-HYDRIN	ammonium lactate	SUN PHARM INDS INC	NDA020508
August 26, 1996	IVY BLOCK	bentoquatam	STAND HOMEOPATH	NDA020532
August 23, 1996	CLARITIN-D 24 HOUR	loratadine, pseudoephedrine sulfate	BAYER HEALTHCARE LLC	NDA020470
August 23, 1996	SEROSTIM	somatropin	EMD SERONO	BLA020604
August 15, 1996	HELIDAC	bismuth subsalicylate, metronidazole, tetracycline hydrochloride	CASPER PHARMA LLC	NDA050719
August 15, 1996	LEVONORGESTREL	levonorgestrel	WYETH PHARMS INC	NDA020627
August 15, 1996	PROVENTIL-HFA	albuterol sulfate	KINDEVA	NDA020503
August 7, 1996	INTRALIPID 20%	soybean oil	FRESENIUS	NDA020248
August 5, 1996	CEREBYX	fosphenytoin sodium	PARKE DAVIS	NDA020450
July 31, 1996	ESTRADIOL	estradiol	SANDOZ	NDA020538
July 29, 1996	GYNE-LOTRIMIN 3	clotrimazole	BAYER HEALTHCARE LLC	NDA020525
July 29, 1996	GYNE-LOTRIMIN 3 COMBINATION PACK	clotrimazole	BAYER HEALTHCARE LLC	NDA020526
July 25, 1996	ALLEGRA	fexofenadine hydrochloride	CHATTEM SANOFI	NDA020625
July 22, 1996	DOVONEX	calcipotriene	LEO PHARMA AS	NDA020554
July 18, 1996	ZITHROMAX	azithromycin	PFIZER	NDA050711
July 12, 1996	ULTIVA	remifentanil hydrochloride	MYLAN INSTITUTIONAL	NDA020630
July 3, 1996	KADIAN	morphine sulfate	ALLERGAN	NDA020616
July 3, 1996	MORPHINE SULFATE	morphine sulfate	SPECGX LLC	NDA020631
July 3, 1996	MYOSCINT	imciromab pentetate	CENTOCOR INC	BLA103634
July 3, 1996	NICOTROL	nicotine	MCNEIL CONS	NDA020536
June 28, 1996	CECLOR CD	cefaclor	LILLY	NDA050673
June 27, 1996	CHILDREN'S ADVIL-FLAVORED	ibuprofen	HALEON US HOLDINGS	NDA020589
June 26, 1996	VANCENASE AQ	beclomethasone dipropionate monohydrate	SCHERING	NDA020469
June 26, 1996	VISTIDE	cidofovir	GILEAD SCIENCES INC	NDA020638
June 21, 1996	MERREM IV	meropenem	PFIZER	NDA050706
June 21, 1996	VIRAMUNE	nevirapine	BOEHRINGER INGELHEIM	NDA020636
June 14, 1996	CAMPTOSAR	irinotecan hydrochloride	PFIZER INC	NDA020571
June 14, 1996	HUMALOG KWIKPEN	insulin lispro recombinant	LILLY	BLA020563
June 14, 1996	REMERON	mirtazapine	ORGANON	NDA020415
June 12, 1996	ZITHROMAX	azithromycin	PFIZER	NDA050730
June 11, 1996	ALBENZA	albendazole	IMPAX LABS INC	NDA020666
June 10, 1996	CHILDREN'S MOTRIN	ibuprofen	KENVUE BRANDS	NDA020603
June 10, 1996	JUNIOR STRENGTH MOTRIN	ibuprofen	KENVUE BRANDS	NDA020602
June 10, 1996	RISPERDAL	risperidone	JANSSEN PHARMS	NDA020588
June 5, 1996	XALATAN	latanoprost	UPJOHN	NDA020597
May 31, 1996	AUGMENTIN '200'	amoxicillin, clavulanate potassium	US ANTIBIOTICS	NDA050726
May 31, 1996	AUGMENTIN '400'	amoxicillin, clavulanate potassium	US ANTIBIOTICS	NDA050725
May 31, 1996	DIFFERIN	adapalene	GALDERMA LABS LP	NDA020338
May 31, 1996	DIFFERIN	adapalene	GALDERMA LABS LP	NDA020380
May 28, 1996	HYCAMTIN	topotecan hydrochloride	SANDOZ	NDA020671
May 23, 1996	ACTHREL	corticorelin ovine triflutate	FERRING	BLA020162
May 21, 1996	DENTIPATCH	lidocaine	NOVEN	NDA020575
May 20, 1996	NASACORT ALLERGY 24 HOUR	triamcinolone acetonide	CHATTEM SANOFI	NDA020468
May 17, 1996	ALOPRIM	allopurinol sodium	MYLAN	NDA020298
May 17, 1996	AVONEX	interferon beta-1a	BIOGEN	BLA103628
May 17, 1996	ETOPOPHOS PRESERVATIVE FREE	etoposide phosphate	CHEPLAPHARM	NDA020457
May 15, 1996	ELDEPRYL	selegiline hydrochloride	QUAGEN	NDA020647
May 15, 1996	GEMZAR	gemcitabine hydrochloride	LILLY	NDA020509
May 14, 1996	TAXOTERE	docetaxel	SANOFI AVENTIS US	NDA020449
May 13, 1996	BUPHENYL	sodium phenylbutyrate	HORIZON THERAP US	NDA020572
May 10, 1996	LAMISIL	terbinafine hydrochloride	NOVARTIS	NDA020539
May 9, 1996	AXID AR	nizatidine	HALEON US HOLDINGS	NDA020555
April 30, 1996	BUPHENYL	sodium phenylbutyrate	HORIZON THERAP US	NDA020573
April 26, 1996	ANGIO-CONRAY	iothalamate sodium	MALLINCKRODT	NDA013319
April 26, 1996	ESTRING	estradiol	PFIZER	NDA020472
April 26, 1996	ESTROVIS	quinestrol	PARKE DAVIS	NDA016768
April 26, 1996	MAVIK	trandolapril	ABBVIE	NDA020528
April 16, 1996	MONISTAT 3 COMBINATION PACK	miconazole nitrate	MEDTECH PRODUCTS	NDA020670
April 8, 1996	DAUNOXOME	daunorubicin citrate	GALEN (UK)	NDA050704
March 29, 1996	EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE	brompheniramine maleate, pseudoephedrine hydrochloride	ALZA	NDA019672
March 27, 1996	FLOVENT	fluticasone propionate	GLAXOSMITHKLINE	NDA020548
March 25, 1996	TEGRETOL-XR	carbamazepine	NOVARTIS	NDA020234
March 22, 1996	NICOTROL	nicotine	PFIZER INC	NDA020385
March 22, 1996	VISIPAQUE 270	iodixanol	GE HEALTHCARE	NDA020351
March 13, 1996	CRIXIVAN	indinavir sulfate	MERCK SHARP DOHME	NDA020685
March 8, 1996	VOLTAREN-XR	diclofenac sodium	NOVARTIS	NDA020254
March 4, 1996	VITRASERT	ganciclovir	BAUSCH AND LOMB	NDA020569
March 1, 1996	NORVIR	ritonavir	ABBVIE	NDA020659
March 1, 1996	NORVIR	ritonavir	ABBOTT	NDA020680
February 29, 1996	GASTROCROM	cromolyn sodium	VIATRIS SPECIALTY	NDA020479
February 26, 1996	COVERA-HS	verapamil hydrochloride	PFIZER	NDA020552
February 23, 1996	DEXFERRUM	iron dextran	AM REGENT	NDA040024
February 13, 1996	AUGMENTIN '875'	amoxicillin, clavulanate potassium	US ANTIBIOTICS	NDA050720
February 9, 1996	MYOVIEW	technetium tc-99m tetrofosmin kit	MEDI-PHYSICS	NDA020372
January 31, 1996	PROCANBID	procainamide hydrochloride	KING PHARMS	NDA020545
January 31, 1996	VISINE	naphazoline hydrochloride, pheniramine maleate	KENVUE BRANDS	NDA020485
January 18, 1996	MAXIPIME	cefepime hydrochloride	HOSPIRA INC	NDA050679
January 11, 1996	ZOLADEX	goserelin acetate	TERSERA	NDA020578
January 5, 1996	NAPRELAN	naproxen sodium	TWI PHARMS	NDA020353