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FDA drug approvals in 1977

FDA approved the original submission of 42 new drug and biologics license applications in 1977, from 27 sponsors. FDA marks 34 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 30, 1977	HYDERGINE	ergoloid mesylates	NOVARTIS	NDA017993
December 30, 1977	NOLVADEX	tamoxifen citrate	ASTRAZENECA	NDA017970
December 30, 1977	SODIUM PERTECHNETATE TC 99M	technetium tc-99m sodium pertechnetate	MALLINCKRODT	NDA017725
December 23, 1977	LIMBITROL	amitriptyline hydrochloride, chlordiazepoxide	CHARTWELL RX	NDA016949
December 21, 1977	MEDROL	methylprednisolone acetate	PHARMACIA AND UPJOHN	NDA018102
December 16, 1977	GALLIUM CITRATE GA 67	gallium citrate ga-67	GE HEALTHCARE	NDA017700
December 16, 1977	OSTEOLITE	technetium tc-99m medronate kit	SUN PHARM INDS INC	NDA017972
December 16, 1977	THALLOUS CHLORIDE TL 201	thallous chloride tl-201	LANTHEUS MEDCL	NDA017806
November 22, 1977	LIORESAL	baclofen	NOVARTIS	NDA017851
September 30, 1977	ATIVAN	lorazepam	BAUSCH	NDA017794
September 21, 1977	TOPICYCLINE	tetracycline hydrochloride	SHIRE	NDA050493
September 14, 1977	FLORONE	diflorasone diacetate	PFIZER	NDA017741
September 7, 1977	AQUATENSEN	methyclothiazide	MEDPOINTE PHARM HLC	NDA017364
September 1, 1977	DIDRONEL	etidronate disodium	APIL	NDA017831
September 1, 1977	NORPACE	disopyramide phosphate	PFIZER	NDA017447
August 26, 1977	FLEXERIL	cyclobenzaprine hydrochloride	JANSSEN RES AND DEV	NDA017821
August 23, 1977	PROSTIN E2	dinoprostone	PFIZER	NDA017810
August 22, 1977	CLODERM	clocortolone pivalate	LEGACY	NDA017765
August 16, 1977	TAGAMET	cimetidine	GLAXOSMITHKLINE	NDA017920
August 16, 1977	TAGAMET	cimetidine hydrochloride	GLAXOSMITHKLINE	NDA017924
August 16, 1977	TAGAMET	cimetidine hydrochloride	GLAXOSMITHKLINE	NDA017939
August 1, 1977	PAMELOR	nortriptyline hydrochloride	SPECGX LLC	NDA018012
August 1, 1977	PAMELOR	nortriptyline hydrochloride	SPECGX LLC	NDA018013
August 1, 1977	PHISO-SCRUB	hexachlorophene	SANOFI AVENTIS US	NDA017446
June 23, 1977	ORTHO-NOVUM 1/35-28	ethinyl estradiol, norethindrone	JANSSEN PHARMS	NDA017919
June 15, 1977	HALOG	halcinonide	WESTWOOD SQUIBB	NDA017818
June 15, 1977	HALOG	halcinonide	SUN PHARM INDS INC	NDA017824
June 9, 1977	NALFON	fenoprofen calcium	DISTA	NDA017710
May 25, 1977	TEPANIL TEN-TAB	diethylpropion hydrochloride	3M	NDA017956
May 4, 1977	HALOG	halcinonide	SUN PHARM INDS INC	NDA017823
April 25, 1977	LODOSYN	carbidopa	ATON	NDA017830
April 12, 1977	DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	dextrose, sodium chloride	OTSUKA ICU MEDCL	NDA017799
April 4, 1977	COLESTID	colestipol hydrochloride	PFIZER	NDA017563
April 1, 1977	MPI STANNOUS DIPHOSPHONATE	technetium tc-99m etidronate kit	GE HEALTHCARE	NDA017667
March 29, 1977	OPTIMINE	azatadine maleate	SCHERING	NDA017601
March 8, 1977	LASIX	furosemide	SANOFI AVENTIS US	NDA017688
March 7, 1977	BICNU	carmustine	AVET LIFESCIENCES	NDA017422
February 28, 1977	TOPICORT	desoximetasone	TARO	NDA017856
February 25, 1977	TAVIST-1	clemastine fumarate	NOVARTIS	NDA017661
February 22, 1977	SCRUBTEAM SURGICAL SPONGEBRUSH	hexachlorophene	3M	NDA017413
February 1, 1977	DIPROSONE	betamethasone dipropionate	SCHERING	NDA017781
February 1, 1977	LORELCO	probucol	SANOFI AVENTIS US	NDA017535