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FDA drug approvals in 1978

FDA approved the original submission of 66 new drug and biologics license applications in 1978, from 46 sponsors. FDA marks 43 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 21, 1978	HEPARIN SODIUM	heparin sodium	ABRAXIS PHARM	NDA017979
December 19, 1978	PLATINOL-AQ	cisplatin	HQ SPCLT PHARMA	NDA018057
November 28, 1978	DRAXIMAGE MDP-10	technetium tc-99m medronate	JUBILANT	NDA018035
November 8, 1978	DEPEN	penicillamine	MYLAN SPECIALITY LP	NDA019854
November 8, 1978	GYNE-LOTRIMIN	clotrimazole	BAYER HEALTHCARE LLC	NDA018052
October 30, 1978	NATACYN	natamycin	HARROW EYE	NDA050514
October 18, 1978	MEFOXIN	cefoxitin sodium	PHARMOBEDIENT	NDA050517
October 18, 1978	MELLARIL-S	thioridazine	NOVARTIS	NDA017923
October 18, 1978	UNISOM	doxylamine succinate	CHATTEM	NDA018066
October 18, 1978	VIRA-A	vidarabine	PARKEDALE	NDA050523
October 17, 1978	RETIN-A	tretinoin	BAUSCH	NDA017955
October 16, 1978	PREMARIN	estrogens, conjugated	WYETH PHARMS	NDA020216
October 12, 1978	PRE-OP II	hexachlorophene	DAVIS AND GECK	NDA017433
October 4, 1978	MONISTAT	miconazole	JANSSEN PHARMA	NDA018040
September 27, 1978	CLINORIL	sulindac	MERCK	NDA017911
September 27, 1978	DIANEAL LOW CALCIUM W/DEXTROSE 4.25% IN PLASTIC CONTAINER	calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate	VANTIVE US HLTHCARE	NDA017512
September 27, 1978	EMETE-CON	benzquinamide hydrochloride	ROERIG	NDA016818
September 27, 1978	MANDOL	cefamandole nafate	LILLY	NDA050504
August 23, 1978	AMIPAQUE	metrizamide	GE HEALTHCARE	NDA017982
August 22, 1978	STADOL	butorphanol tartrate	APOTHECON	NDA017857
August 17, 1978	ROCALTROL	calcitriol	ESJAY PHARMA	NDA018044
August 17, 1978	TIMOPTIC	timolol maleate	BAUSCH AND LOMB INC	NDA018086
August 7, 1978	LOPRESSOR	metoprolol tartrate	VALIDUS PHARMS	NDA017963
July 25, 1978	RENOVUE-65	iodamide meglumine	BRACCO	NDA017902
July 25, 1978	RENOVUE-DIP	iodamide meglumine	BRACCO	NDA017903
July 18, 1978	DOBUTREX	dobutamine hydrochloride	LILLY	NDA017820
July 18, 1978	THYREL TRH	protirelin	FERRING	NDA018087
July 14, 1978	MOTOFEN HALF-STRENGTH	atropine sulfate, difenoxin hydrochloride	LEGACY	NDA017744
July 5, 1978	OVCON-35	ethinyl estradiol, norethindrone	WARNER CHILCOTT	NDA018127
July 5, 1978	OVCON-50	ethinyl estradiol, norethindrone	WARNER CHILCOTT	NDA018128
June 28, 1978	PARLODEL	bromocriptine mesylate	ESJAY PHARMA	NDA017962
May 25, 1978	GLUCOSCAN	technetium tc-99m gluceptate kit	BRISTOL MYERS SQUIBB	NDA017907
May 11, 1978	PROGESTERONE	progesterone	ACTAVIS LABS UT INC	NDA017362
May 1, 1978	NEOSCAN	gallium citrate ga-67	GE HEALTHCARE	NDA017655
April 24, 1978	DEXTROSE 60% IN PLASTIC CONTAINER	dextrose	B BRAUN	NDA017995
April 21, 1978	HEPARIN SODIUM	heparin sodium	PHARM SPEC	NDA017780
April 17, 1978	AN-SULFUR COLLOID	technetium tc-99m sulfur colloid kit	SUN PHARM INDS INC	NDA017858
April 17, 1978	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride	HOSPIRA	NDA018053
April 17, 1978	CALCIMAR	calcitonin salmon	SANOFI AVENTIS US	NDA017769
April 4, 1978	RIMSO-50	dimethyl sulfoxide	MYLAN INSTITUTIONAL	NDA017788
March 17, 1978	WESTCORT	hydrocortisone valerate	SUN PHARM INDS INC	NDA017950
March 1, 1978	PSORCON E	diflorasone diacetate	PFIZER	NDA017994
February 28, 1978	DEPAKENE	valproic acid	ABBVIE	NDA018081
February 28, 1978	DEPAKENE	valproic acid	ABBVIE	NDA018082
February 24, 1978	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	dextrose, sodium chloride	B BRAUN	NDA018030
February 24, 1978	NEPHRAMINE 5.4%	amino acids	B BRAUN	NDA017766
February 21, 1978	DDAVP (NEEDS NO REFRIGERATION)	desmopressin acetate	FERRING PHARMS INC	NDA017922
February 21, 1978	DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	dextrose, sodium chloride	B BRAUN	NDA018047
February 21, 1978	DEXTROSE 10% IN PLASTIC CONTAINER	dextrose	B BRAUN	NDA018046
February 21, 1978	LACTATED RINGER'S IN PLASTIC CONTAINER	calcium chloride, potassium chloride, sodium chloride, sodium lactate	B BRAUN	NDA018023
February 21, 1978	NORMINEST FE	ethinyl estradiol, norethindrone, ferrous fumarate	GD SEARLE LLC	NDA017948
February 21, 1978	TRIDESILON	acetic acid, glacial, desonide	BAYER PHARMS	NDA017914
February 17, 1978	DURICEF	cefadroxil/cefadroxil hemihydrate	WARNER CHILCOTT	NDA050512
February 16, 1978	SORBITOL 3.3% IN PLASTIC CONTAINER	sorbitol	B BRAUN	NDA016741
February 10, 1978	HEPARIN SODIUM	heparin sodium	FRESENIUS KABI USA	NDA017651
February 10, 1978	RESECTISOL IN PLASTIC CONTAINER	mannitol	B BRAUN	NDA016772
February 9, 1978	ACEPHEN	acetaminophen	COSETTE	NDA018060
February 8, 1978	DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	dextrose, sodium chloride	B BRAUN	NDA018026
February 8, 1978	DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER	calcium chloride, dextrose, potassium chloride, sodium chloride, sodium lactate	B BRAUN	NDA017510
February 8, 1978	PHYSIOSOL IN PLASTIC CONTAINER	magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium gluconate	OTSUKA ICU MEDCL	NDA017637
February 8, 1978	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	B BRAUN	NDA017464
February 6, 1978	GLYCINE 1.5% IN PLASTIC CONTAINER	glycine	B BRAUN	NDA016784
February 3, 1978	GERMA-MEDICA	hexachlorophene	HUNTINGTON LABS	NDA017412
January 16, 1978	KINLYTIC	urokinase	MICROBIX BIOSYSTEMS	BLA021846
January 10, 1978	ELSPAR	asparaginase	MERCK	BLA101063
January 3, 1978	NOVAMINE 15%	amino acids, magnesium chloride, potassium acetate, potassium chloride, sodium acetate	HOSPIRA INC	NDA017957