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FDA drug approvals in 1985

FDA approved the original submission of 82 new drug and biologics license applications in 1985, from 52 sponsors. FDA marks 51 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 31, 1985	ISOVUE-250	iopamidol	BRACCO	NDA018735
December 31, 1985	NIZORAL	ketoconazole	JANSSEN PHARMA	NDA019084
December 31, 1985	TRANDATE	labetalol hydrochloride	SEBELA IRELAND LTD	NDA019425
December 31, 1985	VIRAZOLE	ribavirin	BAUSCH	NDA018859
December 30, 1985	MEXITIL	mexiletine hydrochloride	BOEHRINGER INGELHEIM	NDA018873
December 30, 1985	WELLBUTRIN	bupropion hydrochloride	GLAXOSMITHKLINE	NDA018644
December 27, 1985	CARNITOR	levocarnitine	LEADIANT BIOSCI INC	NDA018948
December 27, 1985	CEFOTAN	cefotetan disodium	PAI HOLDINGS PHARM	NDA050588
December 27, 1985	DORAL	quazepam	GALT PHARMS	NDA018708
December 27, 1985	TEMOVATE	clobetasol propionate	FOUGERA	NDA019322
December 27, 1985	TEMOVATE	clobetasol propionate	FOUGERA	NDA019323
December 26, 1985	CESAMET	nabilone	BAUSCH	NDA018677
December 26, 1985	OMNIPAQUE 140	iohexol	GE HEALTHCARE	NDA018956
December 24, 1985	CORDARONE	amiodarone hydrochloride	WYETH PHARMS	NDA018972
December 24, 1985	INDIUM IN 111 OXYQUINOLINE	indium in-111 oxyquinoline	GE HEALTHCARE	NDA019044
December 24, 1985	VASOTEC	enalapril maleate	BAUSCH	NDA018998
December 23, 1985	THERMAZENE	silver sulfadiazine	THEPHARMANETWORK LLC	NDA018810
December 20, 1985	VERSED	midazolam hydrochloride	HLR	NDA018654
December 19, 1985	BETAGAN	levobunolol hydrochloride	ALLERGAN	NDA019219
December 17, 1985	DYNA-HEX 2	chlorhexidine gluconate	XTTRIUM	NDA019422
December 17, 1985	EXIDINE	chlorhexidine gluconate	XTTRIUM	NDA019421
December 10, 1985	NITRO-DUR	nitroglycerin	USPHARMA	NDA020145
December 5, 1985	INTAL	cromolyn sodium	KING PHARMS LLC	NDA018887
November 29, 1985	E-Z SCRUB 201	povidone-iodine	BECTON DICKINSON	NDA019240
November 27, 1985	ADALAT	nifedipine	BAYER PHARMS	NDA019478
November 26, 1985	PRIMAXIN	cilastatin sodium, imipenem	MERCK	NDA050587
November 8, 1985	SYPRINE	trientine hydrochloride	BAUSCH	NDA019194
October 31, 1985	NITROLINGUAL	nitroglycerin	POHL BOSKAMP	NDA018705
October 31, 1985	TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	cimetidine hydrochloride	GLAXOSMITHKLINE	NDA019434
October 31, 1985	TAMBOCOR	flecainide acetate	ALVOGEN	NDA018830
October 29, 1985	MOCTANIN	monoctanoin	ETHITEK	NDA019368
October 10, 1985	INDOCIN	indomethacin	COSETTE	NDA018332
September 17, 1985	DEXTROSE 5% IN PLASTIC CONTAINER	dextrose	HOSPIRA	NDA019479
September 17, 1985	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	HOSPIRA	NDA019480
September 6, 1985	AMINOSYN-PF 7%	amino acids	OTSUKA ICU MEDCL	NDA019398
September 4, 1985	FML	fluorometholone	ALLERGAN	NDA017760
August 30, 1985	BETOPTIC	betaxolol hydrochloride	SANDOZ	NDA019270
August 30, 1985	EXELDERM	sulconazole nitrate	JOURNEY	NDA018738
August 30, 1985	UROCIT-K	potassium citrate	MISSION PHARMA	NDA019071
August 28, 1985	FLORONE E	diflorasone diacetate	PFIZER	NDA019259
August 28, 1985	PSORCON	diflorasone diacetate	PFIZER	NDA019260
August 7, 1985	BAROS	sodium bicarbonate, tartaric acid	MALLINCKRODT INC	NDA018509
July 26, 1985	HEXABRIX	ioxaglate meglumine, ioxaglate sodium	GUERBET	NDA018905
July 22, 1985	AUGMENTIN '125'	amoxicillin, clavulanate potassium	US ANTIBIOTICS	NDA050597
July 22, 1985	DORYX	doxycycline hyclate	MAYNE PHARMA	NDA050582
July 22, 1985	ERYC SPRINKLES	erythromycin	HOSPIRA	NDA050593
July 19, 1985	FORTAZ	ceftazidime	PAI HOLDINGS PHARM	NDA050578
July 18, 1985	LITHANE	lithium carbonate	BAYER PHARMS	NDA018833
July 15, 1985	DEXTROSE 5% IN PLASTIC CONTAINER	dextrose	HOSPIRA	NDA019466
July 15, 1985	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	HOSPIRA	NDA019465
July 12, 1985	AMINOSYN-HBC 7%	amino acids	ICU MEDICAL INC	NDA019374
July 9, 1985	LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER	lidocaine hydrochloride	ABBOTT	NDA018954
July 3, 1985	INDERIDE LA 160/50	hydrochlorothiazide, propranolol hydrochloride	WYETH AYERST	NDA019059
June 28, 1985	TAVIST	clemastine fumarate	NOVARTIS	NDA018675
May 31, 1985	MARINOL	dronabinol	ALKEM LABS LTD	NDA018651
May 24, 1985	RIDAURA	auranofin	LEGACY	NDA018689
May 20, 1985	CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER	cefotaxime sodium	STERIMAX	NDA050596
May 17, 1985	SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER	sodium chloride	BAXTER HLTHCARE	NDA019319
April 25, 1985	COLD CAPSULE IV	chlorpheniramine maleate, phenylpropanolamine hydrochloride	GRAHAM DM	NDA018793
April 24, 1985	LAC-HYDRIN	ammonium lactate	SUN PHARM INDS INC	NDA019155
April 23, 1985	COLD CAPSULE V	chlorpheniramine maleate, phenylpropanolamine hydrochloride	GRAHAM DM	NDA018794
April 9, 1985	LUPRON	leuprolide acetate	ABBVIE ENDOCRINE INC	NDA019010
April 5, 1985	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	dextrose, potassium chloride, sodium chloride	BAXTER HLTHCARE	NDA019308
April 5, 1985	POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	calcium chloride, dextrose, potassium chloride, sodium chloride, sodium lactate	BAXTER HLTHCARE	NDA019367
April 1, 1985	TIMENTIN	clavulanate potassium, ticarcillin disodium	GLAXOSMITHKLINE	NDA050590
March 29, 1985	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	heparin sodium	B BRAUN	NDA019134
March 29, 1985	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	heparin sodium	B BRAUN	NDA019135
March 29, 1985	HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	heparin sodium	B BRAUN	NDA019042
March 29, 1985	OXYTOCIN 10 USP UNITS IN DEXTROSE 5%	oxytocin	ABBOTT	NDA019185
March 27, 1985	HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	heparin sodium	HOSPIRA	NDA019339
March 20, 1985	PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate, pseudoephedrine hydrochloride	GRAHAM DM	NDA018844
March 19, 1985	BRICANYL	terbutaline sulfate	SANOFI AVENTIS US	NDA018000
March 18, 1985	PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate, pseudoephedrine hydrochloride	GRAHAM DM	NDA018843
February 15, 1985	ERYCETTE	erythromycin	JOHNSON AND JOHNSON	NDA050594
January 30, 1985	HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%	heparin sodium	HOSPIRA	NDA018911
January 30, 1985	INDOCIN	indomethacin sodium	RECORDATI RARE	NDA018878
January 26, 1985	DEXTROSE 30% IN PLASTIC CONTAINER	dextrose	OTSUKA ICU MEDCL	NDA019345
January 25, 1985	DEXTROSE 60% IN PLASTIC CONTAINER	dextrose	HOSPIRA	NDA019346
January 25, 1985	ZOVIRAX	acyclovir	PHARMOBEDIENT	NDA018828
January 17, 1985	TOPICORT	desoximetasone	TARO	NDA018594
January 12, 1985	FENTANYL CITRATE	fentanyl citrate	HOSPIRA	NDA019115
January 10, 1985	AKNE-MYCIN	erythromycin	BAUSCH	NDA050584