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FDA drug approvals in 1983

FDA approved the original submission of 70 new drug and biologics license applications in 1983, from 47 sponsors. FDA marks 51 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 29, 1983	CHYMEX	bentiromide	SAVAGE LABS	NDA018366
December 22, 1983	NILSTAT	nystatin	STRIDES PHARMA INTL	NDA050576
December 9, 1983	GAVISCON	aluminum hydroxide, magnesium trisilicate	CHATTEM SANOFI	NDA018685
November 30, 1983	FUROSEMIDE	furosemide	CHARTWELL RX	NDA018413
November 30, 1983	FUROSEMIDE	furosemide	AM REGENT	NDA018579
November 23, 1983	TRACRIUM PRESERVATIVE FREE	atracurium besylate	HOSPIRA	NDA018831
November 18, 1983	METRONIDAZOLE	metronidazole	ABBOTT	NDA018889
November 18, 1983	METRONIDAZOLE IN PLASTIC CONTAINER	metronidazole	HOSPIRA	NDA018890
November 14, 1983	SANDIMMUNE	cyclosporine	NOVARTIS	NDA050573
November 14, 1983	SANDIMMUNE	cyclosporine	NOVARTIS	NDA050574
November 10, 1983	FUROSEMIDE	furosemide	HIKMA	NDA018823
November 10, 1983	VEPESID	etoposide	CORDEN PHARMA	NDA018768
November 1, 1983	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	sodium chloride	BAXTER HLTHCARE	NDA019022
October 31, 1983	HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER	heparin sodium	BAXTER HLTHCARE	NDA018814
October 31, 1983	ISOLYTE E IN PLASTIC CONTAINER	calcium chloride, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium citrate	B BRAUN	NDA018899
October 19, 1983	ZINACEF	cefuroxime sodium	PAI HOLDINGS PHARM	NDA050558
October 6, 1983	FUROSEMIDE	furosemide	SUN PHARM INDS INC	NDA018790
October 3, 1983	TOPICORT	desoximetasone	TARO	NDA018763
September 30, 1983	DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER	dopamine hydrochloride	HOSPIRA	NDA018826
September 29, 1983	METRO I.V. IN PLASTIC CONTAINER	metronidazole	B BRAUN	NDA018900
September 15, 1983	CEFIZOX	ceftizoxime sodium	ASTELLAS	NDA050560
September 12, 1983	LIBRELEASE	chlordiazepoxide	VALEANT PHARM INTL	NDA017813
August 31, 1983	BETAMETHASONE VALERATE	betamethasone valerate	FOUGERA	NDA018861
August 31, 1983	BETAMETHASONE VALERATE	betamethasone valerate	FOUGERA	NDA018865
August 31, 1983	BETAMETHASONE VALERATE	betamethasone valerate	FOUGERA	NDA018866
August 31, 1983	BETATREX	betamethasone valerate	SAVAGE LABS	NDA018862
August 31, 1983	BETATREX	betamethasone valerate	SAVAGE LABS	NDA018863
August 31, 1983	BETATREX	betamethasone valerate	SAVAGE LABS	NDA018867
August 26, 1983	DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER	calcium chloride, dextrose, magnesium chloride, sodium acetate, sodium chloride	B BRAUN	NDA018807
August 18, 1983	METRONIDAZOLE	metronidazole	CHARTWELL MOLECULES	NDA018845
August 18, 1983	METRONIDAZOLE	metronidazole	CHARTWELL MOLECULES	NDA018930
August 8, 1983	WESTCORT	hydrocortisone valerate	SUN PHARM INDS INC	NDA018726
July 28, 1983	CHENIX	chenodiol	LEADIANT BIOSCI INC	NDA018513
July 27, 1983	DIPROLENE	betamethasone dipropionate	ORGANON	NDA018741
July 13, 1983	BUPIVACAINE HYDROCHLORIDE	bupivacaine hydrochloride, epinephrine bitartrate	HOSPIRA	NDA022046
July 8, 1983	WELLCOVORIN	leucovorin calcium	GLAXOSMITHKLINE	NDA018342
July 6, 1983	LOZOL	indapamide	SANOFI AVENTIS US	NDA018538
June 30, 1983	ALUPENT	metaproterenol sulfate	BOEHRINGER INGELHEIM	NDA018761
June 30, 1983	BETADERM	betamethasone valerate	ROACO	NDA018839
June 29, 1983	DEXTROSE 5% AND ELECTROLYTE NO. 75 IN PLASTIC CONTAINER	dextrose, potassium chloride, potassium phosphate, monobasic, sodium chloride, sodium lactate	BAXTER HLTHCARE	NDA018840
June 29, 1983	SOYACAL 10%	soybean oil	ALPHA THERA	NDA018465
June 29, 1983	SOYACAL 20%	soybean oil	ALPHA THERA	NDA018786
June 28, 1983	DOPAMINE HYDROCHLORIDE	dopamine hydrochloride	TELIGENT	NDA018656
June 17, 1983	MYCELEX	clotrimazole	BAYER HLTHCARE	NDA018713
June 9, 1983	ZANTAC 300	ranitidine hydrochloride	GLAXO GRP LTD	NDA018703
May 31, 1983	LITHOSTAT	acetohydroxamic acid	MISSION PHARMA	NDA018749
May 25, 1983	CORZIDE	bendroflumethiazide, nadolol	KING PHARMS LLC	NDA018647
May 10, 1983	SODIUM PHOSPHATES IN PLASTIC CONTAINER	sodium phosphate, dibasic, heptahydrate, sodium phosphate, monobasic, monohydrate	HOSPIRA	NDA018892
May 9, 1983	SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole, trimethoprim	WATSON LABS	NDA018852
May 9, 1983	SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH	sulfamethoxazole, trimethoprim	WATSON LABS	NDA018854
May 4, 1983	SODIUM ACETATE	sodium acetate	HOSPIRA	NDA018893
April 26, 1983	PRALIDOXIME CHLORIDE (AUTOINJECTOR)	pralidoxime chloride	MERIDIAN MEDCL TECHN	NDA018986
April 19, 1983	INDERAL LA	propranolol hydrochloride	ANI PHARMS	NDA018553
April 6, 1983	M.V.I. PEDIATRIC	ascorbic acid, biotin, cyanocobalamin, dexpanthenol, ergocalciferol, folic acid, niacinamide, phytonadione, pyridoxine hydrochloride, riboflavin 5'-phosphate sodium, thiamine hydrochloride, vitamin a, vitamin e	HOSPIRA	NDA018920
April 1, 1983	TODAY	nonoxynol-9	MAYER LABS INC	NDA018683
March 25, 1983	MICROLITE	technetium tc-99m albumin colloid kit	PHARMALUCENCE	BLA018263
March 25, 1983	REGLAN	metoclopramide hydrochloride	ROBINS AH	NDA018821
March 24, 1983	BETA-VAL	betamethasone valerate	COSETTE PHARMS NC	NDA018642
March 10, 1983	DEPAKOTE	divalproex sodium	ABBVIE	NDA018723
March 2, 1983	PROTOSTAT	metronidazole	ORTHO MCNEIL PHARM	NDA018871
February 28, 1983	BUMEX	bumetanide	VALIDUS PHARMS	NDA018225
February 28, 1983	BUMEX	bumetanide	VALIDUS PHARMS	NDA018226
February 28, 1983	NETROMYCIN	netilmicin sulfate	SCHERING	NDA050544
February 18, 1983	TZ-3	tioconazole	PFIZER	NDA018682
February 16, 1983	METRONIDAZOLE	metronidazole	MUTUAL PHARM	NDA018818
January 28, 1983	SULFAMETHOXAZOLE AND TRIMETHOPRIM	sulfamethoxazole, trimethoprim	TEVA	NDA018812
January 19, 1983	NITROL	nitroglycerin	RORER	NDA018774
January 19, 1983	PROVENTIL	albuterol sulfate	SCHERING	NDA018062
January 18, 1983	HYDERGINE LC	ergoloid mesylates	NOVARTIS	NDA018706
January 7, 1983	SULFATRIM	sulfamethoxazole, trimethoprim	PHARM ASSOC	NDA018615