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FDA drug approvals in 1980

FDA approved the original submission of 82 new drug and biologics license applications in 1980, from 40 sponsors. FDA marks 59 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 30, 1980	REGLAN	metoclopramide hydrochloride	ANI PHARMS	NDA017854
December 29, 1980	AZULFIDINE	sulfasalazine	PHARMACIA AND UPJOHN	NDA018605
December 23, 1980	LITHIUM CITRATE	lithium citrate	HIKMA	NDA018421
December 22, 1980	SPECTROBID	bacampicillin hydrochloride	PFIZER	NDA050520
December 19, 1980	LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER	lidocaine hydrochloride	HOSPIRA	NDA018388
December 12, 1980	TOBREX	tobramycin	NOVARTIS	NDA050541
December 12, 1980	YUTOPAR	ritodrine hydrochloride	ASTRAZENECA	NDA018555
December 1, 1980	LUDIOMIL	maprotiline hydrochloride	NOVARTIS	NDA017543
November 28, 1980	AMINOSYN-RF 5.2%	amino acids	ICU MEDICAL INC	NDA018429
November 28, 1980	FLAGYL I.V. RTU IN PLASTIC CONTAINER	metronidazole, metronidazole hydrochloride	PFIZER	NDA018353
November 26, 1980	LITHIUM CARBONATE	lithium carbonate	HIKMA	NDA017812
November 19, 1980	PITOCIN	oxytocin	PH HEALTH	NDA018261
November 3, 1980	SYMMETREL	amantadine hydrochloride	ENDO PHARMS	NDA018101
October 30, 1980	AFRINOL	pseudoephedrine sulfate	SCHERING PLOUGH	NDA018191
October 29, 1980	CYTADREN	aminoglutethimide	NOVARTIS	NDA018202
October 21, 1980	AMOXIL	amoxicillin	US ANTIBIOTICS	NDA050542
October 17, 1980	MICRO-K	potassium chloride	NESHER PHARMS	NDA018238
October 6, 1980	ISOLYTE H W/ DEXTROSE 5% IN PLASTIC CONTAINER	dextrose, magnesium chloride, potassium chloride, sodium acetate, sodium chloride	B BRAUN	NDA018273
October 3, 1980	ISOLYTE E W/ DEXTROSE 5% IN PLASTIC CONTAINER	calcium chloride, dextrose, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium citrate	B BRAUN	NDA018269
October 3, 1980	ISOLYTE M W/ DEXTROSE 5% IN PLASTIC CONTAINER	dextrose, potassium chloride, potassium phosphate, dibasic, sodium acetate, sodium chloride	B BRAUN	NDA018270
October 3, 1980	ISOLYTE R W/ DEXTROSE 5% IN PLASTIC CONTAINER	calcium chloride, dextrose, magnesium chloride, potassium chloride, sodium acetate, sodium chloride	B BRAUN	NDA018271
September 22, 1980	ASENDIN	amoxapine	LEDERLE	NDA018021
September 18, 1980	ALUPENT	metaproterenol sulfate	BOEHRINGER INGELHEIM	NDA017659
September 12, 1980	DURICEF	cefadroxil/cefadroxil hemihydrate	WARNER CHILCOTT	NDA050527
September 5, 1980	DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075%	dextrose, potassium chloride, sodium chloride	B BRAUN	NDA018268
September 4, 1980	ANAPROX DS	naproxen sodium	ATNAHS PHARMA US	NDA018164
September 3, 1980	DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER	calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate	FRESENIUS MEDCL	NDA018379
August 29, 1980	ACHROMYCIN	hydrocortisone, tetracycline hydrochloride	LEDERLE	NDA050272
August 28, 1980	MAZANOR	mazindol	WYETH AYERST	NDA017980
August 25, 1980	PHYSIOSOL PH 7.4 IN PLASTIC CONTAINER	magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium gluconate	HOSPIRA INC	NDA018406
August 11, 1980	ISOLYTE S W/ DEXTROSE 5% IN PLASTIC CONTAINER	dextrose, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium gluconate	B BRAUN	NDA018274
August 6, 1980	DURICEF	cefadroxil/cefadroxil hemihydrate	WARNER CHILCOTT	NDA050528
August 5, 1980	CALDEROL	calcifediol	ORGANON USA INC	NDA018312
August 5, 1980	ISOLYTE S IN PLASTIC CONTAINER	magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium gluconate	B BRAUN	NDA018252
August 5, 1980	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	sodium chloride	HOSPIRA	NDA018380
July 25, 1980	ATIVAN	lorazepam	HIKMA	NDA018140
July 25, 1980	SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER	sodium lactate	HOSPIRA	NDA018249
July 23, 1980	VANSIL	oxamniquine	PFIZER	NDA018069
July 11, 1980	DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	dextrose, sodium chloride	B BRAUN	NDA018386
July 11, 1980	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	dextrose, sodium chloride	B BRAUN	NDA018376
July 9, 1980	CLEOCIN	clindamycin phosphate	PFIZER	NDA050537
July 9, 1980	OXYTOCIN	oxytocin	FRESENIUS KABI USA	NDA018248
June 25, 1980	MECLOMEN	meclofenamate sodium	PARKE DAVIS	NDA018006
June 24, 1980	BECLOVENT	beclomethasone dipropionate	GLAXOSMITHKLINE	NDA018153
June 13, 1980	CINOBAC	cinoxacin	LILLY	NDA018067
June 13, 1980	DEPO-TESTADIOL	estradiol cypionate, testosterone cypionate	PHARMACIA AND UPJOHN	NDA017968
June 13, 1980	MINIZIDE	polythiazide, prazosin hydrochloride	PFIZER	NDA017986
June 12, 1980	MPI KRYPTON 81M GENERATOR	krypton, kr-81m	GE HEALTHCARE	NDA018088
June 10, 1980	LOPURIN	allopurinol	ABBOTT	NDA018297
June 9, 1980	K-TAB	potassium chloride	ABBVIE	NDA018279
June 3, 1980	ERYTHROMYCIN	erythromycin	LILLY	NDA050532
June 3, 1980	STATICIN	erythromycin	WESTWOOD SQUIBB	NDA050526
May 30, 1980	AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER	glycine	BAXTER HLTHCARE	NDA017865
May 30, 1980	PROLOPRIM	trimethoprim	MONARCH PHARMS	NDA017943
May 30, 1980	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	sodium chloride	BAXTER HLTHCARE	NDA017864
May 30, 1980	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	BAXTER HLTHCARE	NDA017867
May 30, 1980	SORBITOL 3% IN PLASTIC CONTAINER	sorbitol	BAXTER HLTHCARE	NDA017863
May 30, 1980	STERILE WATER IN PLASTIC CONTAINER	sterile water for irrigation	BAXTER HLTHCARE	NDA017866
May 30, 1980	TRIMPEX 200	trimethoprim	ROCHE	NDA017952
May 29, 1980	POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER	dextrose, potassium chloride, sodium chloride	OTSUKA ICU MEDCL	NDA018365
May 29, 1980	POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER	dextrose, potassium chloride	OTSUKA ICU MEDCL	NDA018371
May 29, 1980	POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	dextrose, potassium chloride, sodium chloride	OTSUKA ICU MEDCL	NDA018362
May 23, 1980	HIBISTAT	chlorhexidine gluconate	MOLNLYCKE HLTH	NDA018300
May 22, 1980	KLOTRIX	potassium chloride	APOTHECON	NDA017850
May 16, 1980	RINGER'S IN PLASTIC CONTAINER	calcium chloride, potassium chloride, sodium chloride	OTSUKA ICU MEDCL	NDA018251
May 2, 1980	PROPINE	dipivefrin hydrochloride	ALLERGAN	NDA018239
April 29, 1980	DEXTROSE 2.5% IN PLASTIC CONTAINER	dextrose	B BRAUN	NDA018358
April 29, 1980	OXYTOCIN	oxytocin	HIKMA	NDA018243
April 22, 1980	ACETAMINOPHEN	acetaminophen	TARO	NDA018337
April 17, 1980	DEXTROSE 5% IN ACETATED RINGER'S IN PLASTIC CONTAINER	calcium chloride, dextrose, potassium chloride, sodium acetate, sodium chloride	B BRAUN	NDA018258
April 17, 1980	SYNTOCINON	oxytocin	NOVARTIS	NDA018245
April 10, 1980	VIROPTIC	trifluridine	MONARCH PHARMS	NDA018299
March 28, 1980	TOPICORT LP	desoximetasone	TARO	NDA018309
February 22, 1980	GLYCINE 1.5% IN PLASTIC CONTAINER	glycine	OTSUKA ICU MEDCL	NDA018315
February 22, 1980	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	OTSUKA ICU MEDCL	NDA018314
February 22, 1980	SORBITOL-MANNITOL IN PLASTIC CONTAINER	mannitol, sorbitol	OTSUKA ICU MEDCL	NDA018316
February 22, 1980	STERILE WATER IN PLASTIC CONTAINER	sterile water for irrigation	OTSUKA ICU MEDCL	NDA018313
February 18, 1980	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	sterile water for injection	OTSUKA ICU MEDCL	NDA018233
February 8, 1980	LEUCOVORIN CALCIUM	leucovorin calcium	XANODYNE PHARM	NDA018459
January 24, 1980	HALOG-E	halcinonide	SUN PHARM INDS INC	NDA018234
January 15, 1980	DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER	calcium chloride, dextrose, potassium chloride, sodium chloride	HOSPIRA	NDA018254
January 15, 1980	VIBRA-TABS	doxycycline hyclate	PFIZER	NDA050533