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FDA drug approvals in 1986

FDA approved the original submission of 80 new drug and biologics license applications in 1986, from 46 sponsors. FDA marks 48 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 31, 1986	AZACTAM	aztreonam	LABS DELBERT	NDA050580
December 31, 1986	BREVIBLOC	esmolol hydrochloride	BAXTER HLTHCARE	NDA019386
December 31, 1986	OCUFEN	flurbiprofen sodium	ALLERGAN	NDA019404
December 31, 1986	UNASYN	ampicillin sodium, sulbactam sodium	PFIZER	NDA050608
December 30, 1986	CYKLOKAPRON	tranexamic acid	PHARMACIA AND UPJOHN	NDA019280
December 30, 1986	CYKLOKAPRON	tranexamic acid	PFIZER	NDA019281
December 30, 1986	MAXAIR	pirbuterol acetate	BAUSCH	NDA019009
December 30, 1986	VEPESID	etoposide	ONESOURCE SPECIALTY	NDA019557
December 29, 1986	ALFENTA	alfentanil hydrochloride	RISING	NDA019353
December 29, 1986	ATROVENT	ipratropium bromide	BOEHRINGER INGELHEIM	NDA019085
December 17, 1986	AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER	amino acids, dextrose	ABBOTT	NDA019565
December 17, 1986	BETADINE	povidone-iodine	ALCON PHARMS LTD	NDA018634
December 17, 1986	ZANTAC IN PLASTIC CONTAINER	ranitidine hydrochloride	PAI HOLDINGS PHARM	NDA019593
December 16, 1986	AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER	amino acids, dextrose, magnesium chloride, potassium chloride, sodium chloride, sodium phosphate, dibasic, heptahydrate, potassium phosphate, dibasic	ABBOTT	NDA019564
December 16, 1986	CALAN SR	verapamil hydrochloride	PFIZER	NDA019152
December 15, 1986	LAMPRENE	clofazimine	NOVARTIS	NDA019500
December 12, 1986	INDERAL	propranolol hydrochloride	WYETH AYERST	NDA019536
November 5, 1986	TIMOPTIC IN OCUDOSE	timolol maleate	BAUSCH AND LOMB INC	NDA019463
November 4, 1986	PEPCID PRESERVATIVE FREE	famotidine	MERCK	NDA019510
October 31, 1986	CIBACALCIN	calcitonin human	NOVARTIS	NDA018470
October 31, 1986	NOROXIN	norfloxacin	MERCK	NDA019384
October 31, 1986	PROVOCHOLINE	methacholine chloride	METHAPHARM	NDA019193
October 31, 1986	TECHNESCAN HIDA	technetium tc-99m lidofenin kit	DRAXIMAGE	NDA018489
October 31, 1986	VASERETIC	enalapril maleate, hydrochlorothiazide	BAUSCH	NDA019221
October 30, 1986	OXSORALEN-ULTRA	methoxsalen	BAUSCH	NDA019600
October 27, 1986	TENEX	guanfacine hydrochloride	PROMIUS PHARMA	NDA019032
October 22, 1986	CYSTEINE HYDROCHLORIDE	cysteine hydrochloride	HOSPIRA	NDA019523
October 17, 1986	AMINOSYN-PF 10%	amino acids	OTSUKA ICU MEDCL	NDA019492
October 16, 1986	HUMATROPE	somatropin	LILLY	BLA019640
October 15, 1986	DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%	dopamine hydrochloride	B BRAUN	NDA019099
October 15, 1986	PEPCID	famotidine	BAUSCH	NDA019462
September 30, 1986	TEGISON	etretinate	ROCHE	NDA019369
September 29, 1986	BUSPAR	buspirone hydrochloride	BRISTOL MYERS SQUIBB	NDA018731
September 25, 1986	CALCIJEX	calcitriol	ABBVIE	NDA018874
September 24, 1986	ERYTHROCIN	erythromycin lactobionate	HOSPIRA	NDA050609
September 18, 1986	FERTINEX	urofollitropin	SERONO	NDA019415
September 10, 1986	ESTRADERM	estradiol	NOVARTIS	NDA019081
September 9, 1986	PCE	erythromycin	AZURITY	NDA050611
September 8, 1986	MAGNESIUM SULFATE	magnesium sulfate	FRESENIUS KABI USA	NDA019316
August 13, 1986	PERIDEX	chlorhexidine gluconate	SOLVENTUM	NDA019028
August 6, 1986	EXTRA-STRENGTH AIM	sodium monofluorophosphate	CHESEBROUGH PONDS	NDA019518
July 23, 1986	CEFOBID IN PLASTIC CONTAINER	cefoperazone sodium	PFIZER	NDA050613
July 22, 1986	CIDA-STAT	chlorhexidine gluconate	ECOLAB	NDA019258
July 18, 1986	NORQUEST FE	ethinyl estradiol, ferrous fumarate, norethindrone	PFIZER	NDA018926
July 10, 1986	VENTOLIN	albuterol sulfate	GLAXOSMITHKLINE	NDA019112
July 3, 1986	MIACALCIN	calcitonin salmon	MYLAN IRELAND LTD	NDA017808
June 26, 1986	CHROMIC CHLORIDE IN PLASTIC CONTAINER	chromic chloride	HOSPIRA	NDA018961
June 26, 1986	CUPRIC CHLORIDE IN PLASTIC CONTAINER	cupric chloride	HOSPIRA	NDA018960
June 26, 1986	MANGANESE CHLORIDE IN PLASTIC CONTAINER	manganese chloride	HOSPIRA	NDA018962
June 26, 1986	ZINC CHLORIDE IN PLASTIC CONTAINER	zinc chloride	HOSPIRA	NDA018959
June 13, 1986	POTASSIUM CHLORIDE	potassium chloride	SCHERING	NDA019439
June 4, 1986	INTRON A	interferon alfa-2b	SCHERING	BLA103132
June 3, 1986	DEXTROSE 50%	dextrose	HOSPIRA	NDA019445
June 3, 1986	SODIUM BICARBONATE IN PLASTIC CONTAINER	sodium bicarbonate	ABBOTT	NDA019443
May 30, 1986	OCUCLEAR	oxymetazoline hydrochloride	BAYER HEALTHCARE LLC	NDA018471
May 28, 1986	PEDIAPRED	prednisolone sodium phosphate	PAI HOLDINGS	NDA019157
May 8, 1986	IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER	dextrose, magnesium chloride, potassium chloride, potassium phosphate, dibasic, sodium chloride, sodium lactate, sodium phosphate, monobasic anhydrous	HOSPIRA	NDA019515
May 8, 1986	IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER	dextrose, magnesium chloride, potassium chloride, potassium phosphate, monobasic, sodium lactate, sodium phosphate, monobasic anhydrous	OTSUKA ICU MEDCL	NDA019513
May 8, 1986	IONOSOL T AND DEXTROSE 5% IN PLASTIC CONTAINER	dextrose, potassium chloride, potassium lactate, sodium chloride, sodium phosphate, monobasic anhydrous	HOSPIRA	NDA019514
April 30, 1986	OCL	polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride, sodium sulfate	HOSPIRA	NDA019284
April 29, 1986	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	bretylium tosylate	B BRAUN	NDA019121
April 23, 1986	FML FORTE	fluorometholone	ABBVIE	NDA019216
April 17, 1986	KLOR-CON	potassium chloride	UPSHER SMITH LABS	NDA019123
April 16, 1986	BRETYLIUM TOSYLATE	bretylium tosylate	HOSPIRA	NDA019030
April 16, 1986	BRETYLIUM TOSYLATE	bretylium tosylate	HOSPIRA	NDA019033
April 16, 1986	BRETYLIUM TOSYLATE IN DEXTROSE 5%	bretylium tosylate	ABBOTT	NDA019005
April 16, 1986	BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER	bretylium tosylate	HOSPIRA INC	NDA019008
April 15, 1986	VANCOCIN HYDROCHLORIDE	vancomycin hydrochloride	ANI PHARMS	NDA050606
April 10, 1986	CARNITOR SF	levocarnitine	LEADIANT BIOSCI INC	NDA019257
April 3, 1986	AMINOSYN II 10%	amino acids	ICU MEDICAL INC	NDA019438
April 3, 1986	AMINOSYN II 8.5% W/ELECTROLYTES	amino acids, magnesium chloride, potassium chloride, sodium chloride, sodium phosphate, dibasic, potassium phosphate, dibasic, sodium phosphate, dibasic, heptahydrate	ICU MEDICAL INC	NDA019437
March 31, 1986	NIX	permethrin	GLAXOSMITHKLINE	NDA019435
March 26, 1986	INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER	calcium chloride, dextrose, sodium chloride, sodium lactate	FRESENIUS MEDCL	NDA019395
March 6, 1986	ISOCLOR	chlorpheniramine maleate, pseudoephedrine hydrochloride	FISONS	NDA018747
February 11, 1986	FLAREX	fluorometholone acetate	HARROW EYE	NDA019079
January 31, 1986	DIPROLENE	betamethasone dipropionate	SCHERING	NDA019408
January 17, 1986	LACTATED RINGER'S IN PLASTIC CONTAINER	calcium chloride, potassium chloride, sodium chloride, sodium lactate	OTSUKA ICU MEDCL	NDA019416
January 17, 1986	POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	dextrose, potassium chloride, sodium chloride	ICU MEDICAL INC	NDA018876
January 14, 1986	HALDOL	haloperidol decanoate	JANSSEN PHARMS	NDA018701
January 9, 1986	ORUDIS	ketoprofen	WYETH AYERST	NDA018754