FDA data · free, no account

FDA drug approvals in 1953

FDA approved the original submission of 35 new drug and biologics license applications in 1953, from 29 sponsors. FDA marks 29 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 24, 1953	DELATESTRYL	testosterone enanthate	ENDO PHARMS	NDA009165
December 23, 1953	FURADANTIN	nitrofurantoin	CASPER PHARMA LLC	NDA009175
December 22, 1953	HYDROXYSTILBAMIDINE ISETHIONATE	hydroxystilbamidine isethionate	SANOFI AVENTIS US	NDA009166
December 9, 1953	CHLOROMYCETIN HYDROCORTISONE	chloramphenicol, hydrocortisone acetate	PARKEDALE	NDA050202
December 7, 1953	METHOTREXATE SODIUM	methotrexate sodium	STRIDES PHARMA INTL	NDA008085
December 4, 1953	GANTRISIN PEDIATRIC	sulfisoxazole acetyl	ROCHE	NDA009182
December 3, 1953	CORTRIL	hydrocortisone	PFIZER	NDA009127
November 19, 1953	ACHROMYCIN	tetracycline hydrochloride	LEDERLE	NDA050273
November 5, 1953	HYDERGINE	ergoloid mesylates	NOVARTIS	NDA009087
October 28, 1953	THIOSULFIL	sulfamethizole	WYETH AYERST	NDA008565
September 28, 1953	NEOTHYLLINE	dyphylline	TEVA	NDA009088
September 11, 1953	PURINETHOL	mercaptopurine	STASON PHARMS	NDA009053
September 8, 1953	MILONTIN	phensuximide	PARKE DAVIS	NDA008855
July 28, 1953	CORTEF ACETATE	hydrocortisone acetate	PHARMACIA AND UPJOHN	NDA008917
July 27, 1953	DIAMOX	acetazolamide	TEVA BRANDED PHARM	NDA008943
July 22, 1953	PAGITANE	cycrimine hydrochloride	LILLY	NDA008951
July 16, 1953	CALCIUM DISODIUM VERSENATE	edetate calcium disodium	BAUSCH	NDA008922
July 1, 1953	OPHTHAINE	proparacaine hydrochloride	APOTHECON	NDA008883
May 18, 1953	BICILLIN C-R	penicillin g benzathine, penicillin g procaine	KING PHARMS LLC	NDA050138
May 1, 1953	QUELICIN PRESERVATIVE FREE	succinylcholine chloride	HOSPIRA	NDA008845
April 30, 1953	SALPIX	acetrizoate sodium	ORTHO MCNEIL PHARM	NDA009008
April 24, 1953	CAFERGOT	caffeine, ergotamine tartrate	NOVARTIS	NDA009000
April 24, 1953	SUCOSTRIN	succinylcholine chloride	APOTHECON	NDA008847
April 9, 1953	PAMINE FORTE	methscopolamine bromide	FOUGERA	NDA008848
April 2, 1953	PRO-BANTHINE	propantheline bromide	SHIRE	NDA008732
March 30, 1953	CHLOROMYCETIN	chloramphenicol	PARKEDALE	NDA050205
March 12, 1953	XYLOCAINE	lidocaine hydrochloride	EPIC PHARMA LLC	NDA008816
February 20, 1953	M.V.I.-12 ADULT	ascorbic acid, biotin, cyanocobalamin, dexpanthenol, ergocalciferol, folic acid, niacinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, vitamin a, vitamin e, riboflavin 5'-phosphate sodium	HOSPIRA	NDA008809
February 6, 1953	FURADANTIN	nitrofurantoin	PROCTER AND GAMBLE	NDA008693
January 26, 1953	DIBENZYLINE	phenoxybenzamine hydrochloride	ADVANZ PHARMA	NDA008708
January 23, 1953	DARAPRIM	pyrimethamine	TILDE SCIENCES	NDA008578
January 15, 1953	APRESOLINE	hydralazine hydrochloride	NOVARTIS	NDA008303
January 8, 1953	LEVO-DROMORAN	levorphanol tartrate	VALEANT PHARM INTL	NDA008719
January 8, 1953	LEVO-DROMORAN	levorphanol tartrate	VALEANT PHARM INTL	NDA008720
January 6, 1953	DILANTIN-125	phenytoin	VIATRIS	NDA008762