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FDA drug approvals in 1981

FDA approved the original submission of 71 new drug and biologics license applications in 1981, 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, 1981	PROCARDIA	nifedipine	PFIZER	NDA018482
December 30, 1981	DEMULEN 1/35-21	ethinyl estradiol, ethynodiol diacetate	GD SEARLE LLC	NDA018168
December 30, 1981	DEMULEN 1/35-28	ethinyl estradiol, ethynodiol diacetate	GD SEARLE LLC	NDA018160
December 30, 1981	SENSORCAINE	bupivacaine hydrochloride, epinephrine bitartrate	FRESENIUS KABI USA	NDA018304
December 29, 1981	BUPRENEX	buprenorphine hydrochloride	INDIVIOR	NDA018401
December 29, 1981	PIPRACIL	piperacillin sodium	WYETH PHARMS INC	NDA050545
December 24, 1981	DESYREL	trazodone hydrochloride	PRAGMA	NDA018207
December 24, 1981	EMCYT	estramustine phosphate sodium	PHARMACIA AND UPJOHN	NDA018045
December 24, 1981	FLAGYL I.V. RTU IN PLASTIC CONTAINER	metronidazole	BAXTER HLTHCARE	NDA018657
December 21, 1981	LOPID	gemfibrozil	PFIZER PHARMS	NDA018422
December 14, 1981	TEGRETOL	carbamazepine	NOVARTIS	NDA018281
December 11, 1981	TIMOLIDE 10-25	hydrochlorothiazide, timolol maleate	MERCK	NDA018061
November 30, 1981	BRETHINE	terbutaline sulfate	PHARMACARE	NDA018571
November 25, 1981	BLOCADREN	timolol maleate	MERCK	NDA018017
November 25, 1981	TOBREX	tobramycin	NOVARTIS	NDA050555
November 13, 1981	CYCLOCORT	amcinonide	ASTELLAS	NDA018498
November 6, 1981	M.V.C. 9+3	ascorbic acid, biotin, cyanocobalamin, dexpanthenol, ergocalciferol, folic acid, niacinamide, pyridoxine hydrochloride, riboflavin 5'-phosphate sodium, thiamine hydrochloride, vitamin a, vitamin e	ABRAXIS PHARM	NDA018440
October 30, 1981	CARAFATE	sucralfate	ABBVIE	NDA018333
October 30, 1981	METRONIDAZOLE	metronidazole	IVAX SUB TEVA PHARMS	NDA018517
October 29, 1981	DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER	calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate, sodium acetate	B BRAUN	NDA018460
October 28, 1981	BSS PLUS	calcium chloride, dextrose, glutathione disulfide, magnesium chloride, potassium chloride, sodium bicarbonate, sodium chloride, sodium phosphate	ALCON	NDA018469
October 28, 1981	FANSIDAR	pyrimethamine, sulfadoxine	ROCHE	NDA018557
October 26, 1981	LIPOSYN 20%	safflower oil	ABBOTT	NDA018614
October 19, 1981	FUROSEMIDE	furosemide	EPIC PHARMA LLC	NDA018569
October 19, 1981	TRANSDERM-NITRO	nitroglycerin	NOVARTIS	NDA020144
October 16, 1981	PROSTIN VR PEDIATRIC	alprostadil	PFIZER	NDA018484
October 16, 1981	XANAX	alprazolam	UPJOHN	NDA018276
October 6, 1981	NITROGLYCERIN	nitroglycerin	HOSPIRA	NDA018531
October 6, 1981	TIS-U-SOL IN PLASTIC CONTAINER	magnesium sulfate, potassium chloride, potassium phosphate, monobasic, sodium chloride, sodium phosphate	BAXTER HLTHCARE	NDA018336
October 5, 1981	MIDAMOR	amiloride hydrochloride	PADAGIS US	NDA018200
October 5, 1981	MODURETIC 5-50	amiloride hydrochloride, hydrochlorothiazide	MERCK	NDA018201
September 30, 1981	BECONASE	beclomethasone dipropionate	GLAXOSMITHKLINE	NDA018584
September 30, 1981	TRIDIL	nitroglycerin	HOSPIRA	NDA018537
September 24, 1981	NASALIDE	flunisolide	IVAX RES	NDA018148
September 24, 1981	PAXIPAM	halazepam	SCHERING	NDA017736
September 24, 1981	VANCENASE	beclomethasone dipropionate	SCHERING	NDA018521
September 21, 1981	MEZLIN	mezlocillin sodium monohydrate	BAYER PHARMS	NDA050549
September 8, 1981	NITROPRESS	sodium nitroprusside	ABBVIE	NDA018450
August 28, 1981	ALDOMET	methyldopa	MERCK	NDA018389
August 27, 1981	FUROSEMIDE	furosemide	PHARMOBEDIENT	NDA018487
August 27, 1981	HIBICLENS	chlorhexidine gluconate	MOLNLYCKE HLTH	NDA018423
August 19, 1981	TENORMIN	atenolol	TWI PHARMS	NDA018240
August 14, 1981	CHOLOVUE	iodoxamate meglumine	BRACCO	NDA018076
August 14, 1981	CHOLOVUE	iodoxamate meglumine	BRACCO	NDA018077
August 12, 1981	ISOPTIN	verapamil hydrochloride	MT ADAMS	NDA018485
July 29, 1981	LYMPHAZURIN	isosulfan blue	COVIDIEN	NDA018310
July 6, 1981	DOPAMINE HYDROCHLORIDE	dopamine hydrochloride	BAXTER HLTHCARE	NDA018398
June 23, 1981	BACTRIM	sulfamethoxazole, trimethoprim	SUN PHARM INDS INC	NDA018374
June 23, 1981	SEPTRA	sulfamethoxazole, trimethoprim	MONARCH PHARMS	NDA018452
June 12, 1981	NIZORAL	ketoconazole	JANSSEN PHARMS	NDA018533
June 1, 1981	LACRISERT	hydroxypropyl cellulose	BAUSCH AND LOMB INC	NDA018771
May 29, 1981	TENATHAN	bethanidine sulfate	ROBINS AH	NDA017675
May 21, 1981	IBU	ibuprofen	BASF	NDA018197
May 19, 1981	DOPAMINE HYDROCHLORIDE	dopamine hydrochloride	INTL MEDICATION	NDA018014
May 19, 1981	DOPAMINE HYDROCHLORIDE	dopamine hydrochloride	HOSPIRA	NDA018132
May 19, 1981	FUROSEMIDE	furosemide	HIKMA	NDA018267
May 19, 1981	SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole, trimethoprim	TEVA	NDA018242
May 1, 1981	PROVENTIL	albuterol	SCHERING	NDA017559
May 1, 1981	VENTOLIN	albuterol	GLAXOSMITHKLINE	NDA018473
April 22, 1981	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	lidocaine hydrochloride	BAXTER HLTHCARE	NDA018461
April 6, 1981	CAPOTEN	captopril	AARXION ANDA HLDING	NDA018343
March 31, 1981	CHLOR-TRIMETON	chlorpheniramine maleate, pseudoephedrine sulfate	BAYER HEALTHCARE LLC	NDA018397
March 26, 1981	PROFERDEX	iron dextran	NEW RIVER	NDA017807
March 11, 1981	CLAFORAN	cefotaxime sodium	STERIMAX	NDA050547
February 27, 1981	RESTORIL	temazepam	SPECGX LLC	NDA018163
February 24, 1981	DIULO	metolazone	GD SEARLE LLC	NDA018535
February 18, 1981	TECHNESCAN HDP	technetium tc-99m oxidronate kit	CURIUM	NDA018321
February 17, 1981	TECHNETIUM TC-99M MEDRONATE KIT	technetium tc-99m medronate kit	CARDINAL HEALTH 414	NDA018107
January 30, 1981	HYDERGINE	ergoloid mesylates	NOVARTIS	NDA018418
January 26, 1981	ERYC	erythromycin	DR REDDYS LABS SA	NDA050536
January 23, 1981	INTRALIPID 20%	soybean oil	FRESENIUS	NDA018449