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FDA drug approvals in 1968

FDA approved the original submission of 22 new drug and biologics license applications in 1968, from 17 sponsors. FDA marks 18 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 9, 1968	ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE	chloroquine phosphate, primaquine phosphate	SANOFI AVENTIS US	NDA014860
November 26, 1968	OVRAL-28	ethinyl estradiol, norgestrel	WYETH PHARMS	NDA016806
November 15, 1968	VISTARIL	hydroxyzine pamoate	PFIZER	NDA011459
November 8, 1968	NORINYL 1+80 28-DAY	mestranol, norethindrone	GD SEARLE LLC	NDA016725
November 7, 1968	NEOPAP	acetaminophen	POLYMEDICA	NDA016401
November 6, 1968	NORINYL 1+80 21-DAY	mestranol, norethindrone	GD SEARLE LLC	NDA016724
November 4, 1968	XYLOCAINE 1.5% W/ DEXTROSE 7.5%	lidocaine hydrochloride	FRESENIUS KABI USA	NDA016297
August 21, 1968	ORTHO-NOVUM 1/50 28	mestranol, norethindrone	ORTHO MCNEIL JANSSEN	NDA016709
May 24, 1968	HIPPURAN I 131	iodohippurate sodium i-131	MALLINCKRODT	NDA016666
May 9, 1968	PATHOCIL	dicloxacillin sodium	WYETH AYERST	NDA050011
April 22, 1968	PATHOCIL	dicloxacillin sodium	WYETH AYERST	NDA050092
April 16, 1968	OVRAL	ethinyl estradiol, norgestrel	WYETH PHARMS	NDA016672
April 10, 1968	PERTOFRANE	desipramine hydrochloride	SANOFI AVENTIS US	NDA013621
April 1, 1968	DESFERAL	deferoxamine mesylate	MITEM PHARMA	NDA016267
March 20, 1968	ALDOCLOR-250	chlorothiazide, methyldopa	MERCK	NDA016016
March 20, 1968	CHLOROPTIC	chloramphenicol	ALLERGAN	NDA050091
March 20, 1968	IMURAN	azathioprine	LEGACY	NDA016324
March 20, 1968	LASIX	furosemide	SANOFI AVENTIS US	NDA016363
March 11, 1968	TEGRETOL	carbamazepine	NOVARTIS	NDA016608
February 19, 1968	SUBLIMAZE PRESERVATIVE FREE	fentanyl citrate	RISING	NDA016619
February 14, 1968	SYMMETREL	amantadine hydrochloride	ENDO PHARMS	NDA016023
January 16, 1968	SORBITRATE	isosorbide dinitrate	ASTRAZENECA	NDA016192