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FDA drug approvals in 1982

FDA approved the original submission of 103 new drug and biologics license applications in 1982, from 54 sponsors. FDA marks 64 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 30, 1982	LOPROX	ciclopirox	EUROFARMA	NDA018748
December 30, 1982	THALLOUS CHLORIDE TL 201	thallous chloride tl-201	BRACCO	NDA018548
December 29, 1982	BILTRICIDE	praziquantel	BAYER HLTHCARE	NDA018714
December 29, 1982	HYLOREL	guanadrel sulfate	PHARMACIA AND UPJOHN	NDA018104
December 28, 1982	CALCIBIND	cellulose sodium phosphate	MISSION PHARMA	NDA018757
December 27, 1982	LACTATED RINGER'S IN PLASTIC CONTAINER	calcium chloride, potassium chloride, sodium chloride, sodium lactate	B BRAUN	NDA018681
December 23, 1982	SPECTAZOLE	econazole nitrate	ALVOGEN	NDA018751
December 16, 1982	TALWIN NX	naloxone hydrochloride, pentazocine hydrochloride	SANOFI AVENTIS US	NDA018733
December 14, 1982	ACLOVATE	alclometasone dipropionate	FOUGERA	NDA018702
December 14, 1982	ACLOVATE	alclometasone dipropionate	FOUGERA	NDA018707
December 13, 1982	PROTOPAM CHLORIDE	pralidoxime chloride	BAXTER HLTHCARE CORP	NDA018799
November 29, 1982	ACETATED RINGER'S IN PLASTIC CONTAINER	calcium chloride, potassium chloride, sodium acetate, sodium chloride	B BRAUN	NDA018725
November 18, 1982	CEFOBID	cefoperazone sodium	PFIZER	NDA050551
November 15, 1982	HALCION	triazolam	PFIZER	NDA017892
November 10, 1982	CHYMODIACTIN	chymopapain	DISCURE MEDICAL, LLC	BLA018663
November 9, 1982	POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER	dextrose, potassium chloride	B BRAUN	NDA018744
November 9, 1982	RINGER'S IN PLASTIC CONTAINER	calcium chloride, potassium chloride, sodium chloride	B BRAUN	NDA018721
November 9, 1982	SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	potassium chloride, sodium chloride	B BRAUN	NDA018722
November 5, 1982	CARDIZEM	diltiazem hydrochloride	BAUSCH	NDA018602
October 29, 1982	AMINOCAPROIC ACID	aminocaproic acid	BAXTER HLTHCARE	NDA018590
October 29, 1982	BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	HOSPIRA	NDA018800
October 29, 1982	LOCOID	hydrocortisone butyrate	PRECISION DERMAT	NDA018652
October 29, 1982	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	HOSPIRA	NDA018803
October 28, 1982	HUMULIN N	insulin susp isophane recombinant human	LILLY	BLA018781
October 28, 1982	HUMULIN R PEN	insulin recombinant human, insulin human	LILLY	BLA018780
October 27, 1982	BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER	sterile water for injection	HOSPIRA	NDA018802
October 27, 1982	STERILE WATER FOR INJECTION	sterile water for injection	HOSPIRA	NDA018801
October 22, 1982	METRONIDAZOLE	metronidazole	FOSUN PHARMA	NDA018740
October 22, 1982	ZOVIRAX	acyclovir sodium	GLAXOSMITHKLINE	NDA018603
October 14, 1982	IOSAT	potassium iodide	ANBEX	NDA018664
October 8, 1982	DELSYM	dextromethorphan polistirex	RECKITT BENCKISER	NDA018658
October 1, 1982	XENON XE 127	xenon xe-127	MALLINCKRODT	NDA018536
September 30, 1982	FACTREL	gonadorelin hydrochloride	HIKMA	NDA018123
September 23, 1982	TALACEN	acetaminophen, pentazocine hydrochloride	SANOFI AVENTIS US	NDA018458
September 17, 1982	METRONIDAZOLE	metronidazole	WATSON LABS	NDA018764
September 7, 1982	AMIDATE	etomidate	HOSPIRA	NDA018227
September 7, 1982	WYTENSIN	guanabenz acetate	WYETH AYERST	NDA018587
September 3, 1982	VISKEN	pindolol	NOVARTIS	NDA018285
August 31, 1982	METRO I.V.	metronidazole	B BRAUN	NDA018674
August 10, 1982	MINOCYCLINE HYDROCHLORIDE	minocycline hydrochloride	TRIAX PHARMS	NDA050451
August 5, 1982	AMERSCAN MDP KIT	technetium tc-99m medronate kit	GE HEALTHCARE	NDA018335
August 3, 1982	HEPATAMINE 8%	amino acids	B BRAUN	NDA018676
August 2, 1982	OVIDE	malathion	TARO	NDA018613
July 30, 1982	TRIMETHOPRIM	trimethoprim	DR REDDYS LABS SA	NDA018679
July 28, 1982	SODIUM NITROPRUSSIDE	sodium nitroprusside	BAXTER HLTHCARE	NDA018581
July 27, 1982	FUROSEMIDE	furosemide	ESJAY PHARMA	NDA018415
July 26, 1982	LANOXICAPS	digoxin	GLAXOSMITHKLINE LLC	NDA018118
July 26, 1982	THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER	theophylline	BAXTER HLTHCARE	NDA018649
July 21, 1982	NORDETTE-28	ethinyl estradiol, levonorgestrel	TEVA BRANDED PHARM	NDA018782
July 20, 1982	NORPACE CR	disopyramide phosphate	PFIZER	NDA018655
July 13, 1982	MVC PLUS	ascorbic acid, biotin, cyanocobalamin, dexpanthenol, ergocalciferol, folic acid, niacinamide, pyridoxine hydrochloride, riboflavin 5'-phosphate sodium, thiamine hydrochloride, vitamin a, vitamin e	WATSON LABS	NDA018439
June 30, 1982	STERILE WATER FOR INJECTION IN PLASTIC CONTAINER	sterile water for injection	BAXTER HLTHCARE	NDA018632
June 22, 1982	IRRIGATING SOLUTION G IN PLASTIC CONTAINER	citric acid, magnesium oxide, sodium carbonate	BAXTER HLTHCARE	NDA018519
May 28, 1982	FUROSEMIDE	furosemide	HOSPIRA	NDA018667
May 28, 1982	INTAL	cromolyn sodium	KING PHARMS LLC	NDA018596
May 27, 1982	SODIUM IODIDE I 123	sodium iodide i-123	CARDINAL HEALTH 418	NDA018671
May 19, 1982	SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH	sulfamethoxazole, trimethoprim	FOSUN PHARMA	NDA018598
May 18, 1982	MPI DMSA KIDNEY REAGENT	technetium tc-99m succimer kit	GE HEALTHCARE	NDA017944
May 14, 1982	FUROSEMIDE	furosemide	WATSON LABS	NDA018369
May 10, 1982	NORDETTE-21	ethinyl estradiol, levonorgestrel	TEVA BRANDED PHARM	NDA018668
May 7, 1982	ACCUTANE	isotretinoin	HOFFMANN LA ROCHE	NDA018662
May 7, 1982	PROVENTIL	albuterol sulfate	SCHERING	NDA017853
May 7, 1982	ZANOSAR	streptozocin	TEVA PHARMS USA	NDA050577
May 6, 1982	PROCALAMINE	amino acids, calcium acetate, glycerin, magnesium acetate, phosphoric acid, potassium chloride, sodium acetate, sodium chloride	B BRAUN	NDA018582
April 28, 1982	HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	heparin sodium	BAXTER HLTHCARE	NDA018609
April 23, 1982	AZMACORT	triamcinolone acetonide	ABBVIE	NDA018117
April 21, 1982	AYGESTIN	norethindrone acetate	DURAMED RES	NDA018405
April 19, 1982	DOLOBID	diflunisal	MERCK	NDA018445
April 6, 1982	FELDENE	piroxicam	PFIZER	NDA018147
March 31, 1982	LOCOID	hydrocortisone butyrate	BAUSCH	NDA018514
March 30, 1982	RITALIN-SR	methylphenidate hydrochloride	NOVARTIS	NDA018029
March 29, 1982	ESKALITH CR	lithium carbonate	JDS PHARMS	NDA018152
March 29, 1982	TOPICORT	desoximetasone	TARO	NDA018586
March 29, 1982	ZOVIRAX	acyclovir	BAUSCH	NDA018604
March 23, 1982	DEXTROSE 20% IN PLASTIC CONTAINER	dextrose	OTSUKA ICU MEDCL	NDA018564
March 23, 1982	DEXTROSE 40% IN PLASTIC CONTAINER	dextrose	OTSUKA ICU MEDCL	NDA018562
March 23, 1982	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER	dextrose, potassium chloride, sodium chloride	BAXTER HLTHCARE	NDA018629
March 23, 1982	DEXTROSE 50% IN PLASTIC CONTAINER	dextrose	OTSUKA ICU MEDCL	NDA018563
March 23, 1982	DEXTROSE 70% IN PLASTIC CONTAINER	dextrose	OTSUKA ICU MEDCL	NDA018561
March 23, 1982	SPECTROBID	bacampicillin hydrochloride	PFIZER	NDA050556
March 23, 1982	TRINALIN	azatadine maleate, pseudoephedrine sulfate	SCHERING	NDA018506
March 22, 1982	SEROPHENE	clomiphene citrate	EMD SERONO	NDA018361
March 16, 1982	HEPATOLITE	technetium tc-99m disofenin kit	SUN PHARM INDS INC	NDA018467
March 15, 1982	MONISTAT 7	miconazole nitrate	MEDTECH PRODUCTS	NDA018520
March 9, 1982	XENON XE 133	xenon xe-133	CURIUM	NDA018327
March 8, 1982	ISOPTIN	verapamil hydrochloride	MT ADAMS	NDA018593
March 4, 1982	METRONIDAZOLE	metronidazole	FOSUN PHARMA	NDA018620
February 26, 1982	PLEGISOL IN PLASTIC CONTAINER	calcium chloride, magnesium chloride, potassium chloride, sodium chloride	HOSPIRA	NDA018608
February 26, 1982	TRAVAMULSION 10%	soybean oil	BAXTER HLTHCARE	NDA018660
February 25, 1982	SSD AF	silver sulfadiazine	DR REDDYS	NDA018578
February 23, 1982	INDOCIN SR	indomethacin	ZYLA	NDA018185
February 19, 1982	ACETIC ACID 0.25% IN PLASTIC CONTAINER	acetic acid, glacial	BAXTER HLTHCARE	NDA018523
February 19, 1982	LACTATED RINGER'S IN PLASTIC CONTAINER	calcium chloride, potassium chloride, sodium chloride, sodium lactate	BAXTER HLTHCARE	NDA018494
February 19, 1982	POTASSIUM IODIDE	potassium iodide	ROXANE	NDA018551
February 19, 1982	RINGER'S IN PLASTIC CONTAINER	calcium chloride, potassium chloride, sodium chloride	BAXTER HLTHCARE	NDA018495
February 19, 1982	TIS-U-SOL	magnesium sulfate, potassium chloride, potassium phosphate, monobasic, sodium chloride, sodium phosphate	BAXTER HLTHCARE	NDA018508
February 18, 1982	MPI INDIUM DTPA IN 111	indium in-111 pentetate disodium	GE HEALTHCARE	NDA017707
February 12, 1982	CORTIFOAM	hydrocortisone acetate	VIATRIS	NDA017351
February 1, 1982	THALLOUS CHLORIDE TL 201	thallous chloride tl-201	GE HEALTHCARE	NDA018110
January 29, 1982	LITHIUM CARBONATE	lithium carbonate	HIKMA	NDA018558
January 27, 1982	TECHNESCAN GLUCEPTATE	technetium tc-99m gluceptate kit	DRAXIMAGE	NDA018272
January 11, 1982	ORTHO-NOVUM 10/11-28	ethinyl estradiol, norethindrone	ORTHO MCNEIL JANSSEN	NDA018354
January 5, 1982	NITRO-BID	nitroglycerin	SANOFI AVENTIS US	NDA018621