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FDA drug approvals in 1964

FDA approved the original submission of 38 new drug and biologics license applications in 1964, from 32 sponsors. FDA marks 31 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 29, 1964	LINCOCIN	lincomycin hydrochloride	PHARMACIA AND UPJOHN	NDA050316
December 29, 1964	LINCOCIN	lincomycin hydrochloride	PFIZER	NDA050317
December 23, 1964	DYMELOR	acetohexamide	LILLY	NDA013378
December 18, 1964	CORTISPORIN	hydrocortisone, neomycin sulfate, polymyxin b sulfate	MONARCH PHARMS	NDA050169
December 12, 1964	MEPROBAMATE	meprobamate	WEST WARD	NDA015417
December 10, 1964	COSMEGEN	dactinomycin	RECORDATI RARE	NDA050682
December 4, 1964	HEXADROL	dexamethasone sodium phosphate	ASPEN GLOBAL INC	NDA014694
November 20, 1964	NORPRAMIN	desipramine hydrochloride	VALIDUS PHARMS	NDA014399
November 6, 1964	AVENTYL	nortriptyline hydrochloride	RANBAXY	NDA014685
November 6, 1964	AVENTYL HYDROCHLORIDE	nortriptyline hydrochloride	LILLY	NDA014684
October 19, 1964	NEO-CORT-DOME	hydrocortisone, neomycin sulfate	BAYER PHARMS	NDA050237
September 22, 1964	DECLOMYCIN	demeclocycline hydrochloride	COREPHARMA	NDA050261
September 8, 1964	TERRAMYCIN	oxytetracycline hydrochloride	PFIZER	NDA050286
September 4, 1964	ALBAMYCIN	novobiocin sodium	PHARMACIA AND UPJOHN	NDA050339
August 10, 1964	DYRENIUM	triamterene	ADVANZ PHARMA	NDA013174
July 30, 1964	MANNITOL 20%	mannitol	B BRAUN	NDA014738
July 24, 1964	TRISORALEN	trioxsalen	VALEANT PHARM INTL	NDA012697
June 29, 1964	ILOTYCIN	erythromycin	DISTA	NDA050368
June 25, 1964	ERYTHROCIN	erythromycin lactobionate	HOSPIRA	NDA050182
June 8, 1964	AMICAR	aminocaproic acid	EPIC PHARMA LLC	NDA015229
June 8, 1964	OSMITROL 20% IN WATER IN PLASTIC CONTAINER	mannitol	BAXTER HLTHCARE	NDA013684
June 4, 1964	AMICAR	aminocaproic acid	HIKMA	NDA015230
June 3, 1964	AMICAR	aminocaproic acid	HIKMA	NDA015197
May 28, 1964	MAXIBOLIN	ethylestrenol	ORGANON USA INC	NDA014005
May 27, 1964	SYNALAR	fluocinolone acetonide	EUROFARMA	NDA015296
May 8, 1964	REGROTON	chlorthalidone, reserpine	SANOFI AVENTIS US	NDA015103
April 13, 1964	CELESTONE	betamethasone	MERCK SHARP DOHME	NDA014215
April 13, 1964	MEPROBAMATE	meprobamate	MALLARD	NDA015072
April 6, 1964	STOXIL	idoxuridine	GLAXOSMITHKLINE	NDA013934
April 1, 1964	ELASE-CHLOROMYCETIN	chloramphenicol, desoxyribonuclease, fibrinolysin	PARKE DAVIS	BLA050294
March 12, 1964	PROTOPAM CHLORIDE	pralidoxime chloride	WYETH AYERST	NDA014122
March 11, 1964	PROTOPAM CHLORIDE	pralidoxime chloride	BAXTER HLTHCARE CORP	NDA014134
March 11, 1964	XYLOCAINE	lidocaine	ASTRAZENECA	NDA014127
March 6, 1964	NEGGRAM	nalidixic acid	SANOFI AVENTIS US	NDA014214
March 6, 1964	XYLOCAINE	lidocaine	ASTRAZENECA	NDA013077
March 5, 1964	NORINYL	mestranol, norethindrone	ACTAVIS LABS UT INC	NDA013625
March 4, 1964	NORGESIC FORTE	aspirin, caffeine, orphenadrine citrate	BAUSCH	NDA013416
January 17, 1964	ALKERAN	melphalan	APOTEX	NDA014691