FDA data · free, no account

FDA drug approvals in 1988

FDA approved the original submission of 59 new drug and biologics license applications in 1988, from 43 sponsors. FDA marks 30 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 30, 1988	CERADON	cefotiam hydrochloride	TAKEDA	NDA050601
December 30, 1988	CERETEC	technetium tc-99m exametazime kit	GE HEALTHCARE	NDA019829
December 30, 1988	LOPROX	ciclopirox	EUROFARMA	NDA019824
December 30, 1988	MESNEX	mesna	BAXTER HLTHCARE	NDA019884
December 30, 1988	OPTIRAY 350	ioversol	LIEBEL-FLARSHEIM	NDA019710
December 30, 1988	OXISTAT	oxiconazole nitrate	FOUGERA	NDA019828
December 30, 1988	PERMAX	pergolide mesylate	VALEANT PHARM INTL	NDA019385
December 30, 1988	ZANTAC	ranitidine hydrochloride	GLAXO GRP LTD	NDA019675
December 28, 1988	CARTROL	carteolol hydrochloride	ABBVIE	NDA019204
December 28, 1988	NIMOTOP	nimodipine	BAYER PHARMS	NDA018869
December 27, 1988	CYTOTEC	misoprostol	PFIZER	NDA019268
December 23, 1988	PROFENAL	suprofen	ALCON	NDA019387
December 22, 1988	ETHAMOLIN	ethanolamine oleate	QOL MEDCL	NDA019357
December 21, 1988	CARDENE	nicardipine hydrochloride	CHIESI	NDA019488
December 20, 1988	THALITONE	chlorthalidone	CASPER PHARMA LLC	NDA019574
December 5, 1988	QUESTRAN LIGHT	cholestyramine	BRISTOL MYERS	NDA019669
December 2, 1988	PHARMASEAL SCRUB CARE	chlorhexidine gluconate	CAREFUSION 2200	NDA019793
November 22, 1988	METROGEL	metronidazole	GALDERMA LABS LP	NDA019737
November 7, 1988	AMINOSYN II 5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER	amino acids, calcium chloride, dextrose, magnesium chloride, potassium chloride, potassium phosphate, dibasic, sodium chloride	HOSPIRA INC	NDA019683
November 1, 1988	AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER	amino acids, dextrose	HOSPIRA	NDA019681
November 1, 1988	AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER	amino acids, dextrose, magnesium chloride, potassium acetate, potassium chloride, potassium phosphate, dibasic, sodium chloride, sodium phosphate, dibasic, heptahydrate	HOSPIRA INC	NDA019682
October 31, 1988	ANSAID	flurbiprofen	PHARMACIA AND UPJOHN	NDA018766
October 21, 1988	SANDOSTATIN	octreotide acetate	NOVARTIS	NDA019667
October 20, 1988	POLYTRIM	polymyxin b sulfate, trimethoprim sulfate	ALLERGAN	NDA050567
October 17, 1988	POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	calcium chloride, dextrose, potassium chloride, sodium chloride, sodium lactate	OTSUKA ICU MEDCL	NDA019685
October 17, 1988	POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	potassium chloride, sodium chloride	OTSUKA ICU MEDCL	NDA019686
October 13, 1988	POTASSIUM CITRATE	potassium citrate	UT SW MEDCTR	NDA019647
September 28, 1988	TOBRADEX	dexamethasone, tobramycin	NOVARTIS	NDA050616
September 23, 1988	TRAVASOL 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER	amino acids, dextrose	BAXTER HLTHCARE	NDA019520
September 16, 1988	RETIN-A	tretinoin	BAUSCH	NDA019049
September 2, 1988	DILATRATE-SR	isosorbide dinitrate	ENDO OPERATIONS	NDA019790
August 26, 1988	MICRO-K LS	potassium chloride	KV PHARM	NDA019561
August 26, 1988	VASOCIDIN	prednisolone sodium phosphate, sulfacetamide sodium	NOVARTIS	NDA018988
August 18, 1988	TOBRADEX	dexamethasone, tobramycin	SANDOZ	NDA050592
August 17, 1988	ROGAINE (FOR WOMEN)	minoxidil	KENVUE BRANDS	NDA019501
August 11, 1988	THIOLA	tiopronin	MISSION PHARMA	NDA019569
August 2, 1988	PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate, pseudoephedrine hydrochloride	CENT PHARMS	NDA019428
August 1, 1988	DIPROLENE	betamethasone dipropionate	ORGANON	NDA019716
July 28, 1988	VOLTAREN	diclofenac sodium	NOVARTIS	NDA019201
June 13, 1988	CYCLOCORT	amcinonide	ASTELLAS	NDA019729
June 10, 1988	PRED-G	gentamicin sulfate, prednisolone acetate	ALLERGAN	NDA050586
June 8, 1988	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	sodium chloride	HOSPIRA	NDA019759
June 2, 1988	MAGNEVIST	gadopentetate dimeglumine	BAYER HLTHCARE	NDA019596
May 24, 1988	TERAZOL 3	terconazole	JANSSEN PHARMS	NDA019641
May 19, 1988	ZESTRIL	lisinopril	TWI PHARMS	NDA019777
May 4, 1988	VENTOLIN ROTACAPS	albuterol sulfate	GLAXOSMITHKLINE	NDA019489
April 12, 1988	AXID	nizatidine	SMITHKLINE BEECHAM	NDA019508
March 24, 1988	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	dextrose, potassium chloride, sodium chloride	OTSUKA ICU MEDCL	NDA019691
March 9, 1988	SODIUM CHLORIDE 5% IN PLASTIC CONTAINER	sodium chloride	B BRAUN	NDA019635
March 1, 1988	IMODIUM A-D	loperamide hydrochloride	KENVUE BRANDS	NDA019487
February 29, 1988	LACTATED RINGER'S IN PLASTIC CONTAINER	calcium chloride, potassium chloride, sodium chloride, sodium lactate	B BRAUN	NDA019632
February 29, 1988	NAFTIN	naftifine hydrochloride	LEGACY	NDA019599
February 29, 1988	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	sterile water for injection	B BRAUN	NDA019633
February 24, 1988	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	dextrose, sodium chloride	B BRAUN	NDA019631
February 24, 1988	DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER	calcium chloride, dextrose, potassium chloride, sodium chloride, sodium lactate	B BRAUN	NDA019634
February 17, 1988	POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	dextrose, potassium chloride, sodium chloride	B BRAUN	NDA019630
February 9, 1988	VASOTEC	enalaprilat	BIOVAIL LABS INTL	NDA019309
February 3, 1988	DERMA-SMOOTHE/FS	fluocinolone acetonide	HILL DERMAC	NDA019452
February 2, 1988	DEXTROSE 70% IN PLASTIC CONTAINER	dextrose	B BRAUN	NDA019626