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FDA drug approvals in 1992

FDA approved the original submission of 89 new drug and biologics license applications in 1992, from 55 sponsors. FDA marks 54 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

Approved	Brand	Ingredient	Sponsor	Application
December 31, 1992	SINE-AID IB	ibuprofen, pseudoephedrine hydrochloride	KENVUE BRANDS	NDA019899
December 31, 1992	ZOFRAN	ondansetron hydrochloride	SANDOZ	NDA020103
December 30, 1992	EMLA	lidocaine, prilocaine	TEVA BRANDED PHARM	NDA019941
December 30, 1992	LAMISIL	terbinafine hydrochloride	NOVARTIS	NDA020192
December 30, 1992	TILADE	nedocromil sodium	KING PHARMS LLC	NDA019660
December 29, 1992	INDICLOR	indium in-111 chloride	GE HEALTHCARE	NDA019862
December 29, 1992	PAXIL	paroxetine hydrochloride	APOTEX	NDA020031
December 29, 1992	TAXOL	paclitaxel	HQ SPCLT PHARMA	NDA020262
December 29, 1992	ZEFAZONE IN PLASTIC CONTAINER	cefmetazole sodium	PHARMACIA AND UPJOHN	NDA050683
December 28, 1992	IMITREX STATDOSE	sumatriptan succinate	GLAXOSMITHKLINE	NDA020080
December 23, 1992	MYCOBUTIN	rifabutin	PFIZER	NDA050689
December 23, 1992	VOLMAX	albuterol sulfate	MURO	NDA019604
December 16, 1992	AMBIEN	zolpidem tartrate	COSETTE	NDA019908
December 16, 1992	CARNITOR	levocarnitine	LEADIANT BIOSCI INC	NDA020182
December 15, 1992	SUDAFED 24 HOUR	pseudoephedrine hydrochloride	KENVUE BRANDS	NDA020021
December 14, 1992	ORTHO-CEPT	desogestrel, ethinyl estradiol	JANSSEN PHARMS	NDA020301
December 10, 1992	DESOGEN	desogestrel, ethinyl estradiol	ORGANON USA INC	NDA020071
December 9, 1992	PREPIDIL	dinoprostone	PFIZER	NDA019617
December 7, 1992	DEXTROSE 5% IN PLASTIC CONTAINER	dextrose	BAXTER HLTHCARE	NDA020179
December 7, 1992	DILAUDID	hydromorphone hydrochloride	RHODES PHARMS	NDA019891
December 7, 1992	DILAUDID	hydromorphone hydrochloride	RHODES PHARMS	NDA019892
December 7, 1992	SHADE UVAGUARD	avobenzone, octinoxate, oxybenzone	BAYER HEALTHCARE LLC	NDA020045
December 7, 1992	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	BAXTER HLTHCARE	NDA020178
December 4, 1992	DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER	calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate	VANTIVE US HLTHCARE	NDA020183
December 4, 1992	DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER	calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate	VANTIVE US HLTHCARE	NDA020163
November 30, 1992	MAXAIR	pirbuterol acetate	BAUSCH	NDA020014
November 30, 1992	POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER	potassium chloride	OTSUKA ICU MEDCL	NDA020161
November 25, 1992	MEPRON	atovaquone	GLAXOSMITHKLINE LLC	NDA020259
November 20, 1992	PSORCON	diflorasone diacetate	TARO PHARMS NORTH	NDA020205
November 18, 1992	ALKERAN	melphalan hydrochloride	APOTEX	NDA020207
November 16, 1992	PROHANCE	gadoteridol	BRACCO	NDA020131
November 9, 1992	ACULAR	ketorolac tromethamine	ABBVIE	NDA019700
October 30, 1992	BETAPACE	sotalol hydrochloride	LEGACY	NDA019865
October 30, 1992	KERLEDEX	betaxolol hydrochloride, chlorthalidone	SANOFI AVENTIS US	NDA019807
October 30, 1992	MORPHINE SULFATE	morphine sulfate	ICU MEDICAL INC	NDA019916
October 30, 1992	MORPHINE SULFATE	morphine sulfate	ICU MEDICAL INC	NDA019917
October 29, 1992	DAYPRO	oxaprozin	PFIZER	NDA018841
October 29, 1992	DEPO-PROVERA	medroxyprogesterone acetate	PFIZER	NDA020246
September 30, 1992	OXISTAT	oxiconazole nitrate	ANI PHARMS	NDA020209
September 18, 1992	SUPRANE	desflurane	BAXTER HLTHCARE	NDA020118
September 11, 1992	SPORANOX	itraconazole	JANSSEN PHARMS	NDA020083
September 4, 1992	ACTINEX	masoprocol	UNIV AZ CANCER CTR	NDA019940
September 3, 1992	BRONCHO SALINE	sodium chloride	BLAIREX	NDA019912
September 3, 1992	BUPIVACAINE HYDROCHLORIDE KIT	bupivacaine hydrochloride	HOSPIRA	NDA019978
August 21, 1992	TAVIST-1	clemastine fumarate	HALEON US HOLDINGS	NDA020925
August 19, 1992	DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER	calcium chloride, dextrose, magnesium chloride, sodium chloride, sodium lactate	FRESENIUS MEDCL	NDA020171
August 17, 1992	METROGEL-VAGINAL	metronidazole	BAUSCH	NDA020208
August 14, 1992	THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER	theophylline	B BRAUN	NDA019826
August 11, 1992	CLEOCIN	clindamycin phosphate	PFIZER	NDA050680
August 7, 1992	BANAN	cefpodoxime proxetil	SANKYO	NDA050687
August 7, 1992	BANAN	cefpodoxime proxetil	SANKYO	NDA050688
August 7, 1992	VANTIN	cefpodoxime proxetil	PFIZER	NDA050674
August 7, 1992	VANTIN	cefpodoxime proxetil	PFIZER	NDA050675
July 31, 1992	NORVASC	amlodipine besylate	VIATRIS	NDA019787
July 31, 1992	ZEBETA	bisoprolol fumarate	TEVA BRANDED PHARM	NDA019982
July 30, 1992	FIORICET W/ CODEINE	acetaminophen, butalbital, caffeine, codeine phosphate	ACTAVIS LABS UT INC	NDA020232
July 24, 1992	HALFAN	halofantrine hydrochloride	GLAXOSMITHKLINE	NDA020250
July 20, 1992	HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER	heparin sodium	B BRAUN	NDA019952
July 20, 1992	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	heparin sodium	B BRAUN	NDA019953
July 20, 1992	HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	heparin sodium	B BRAUN	NDA019802
July 14, 1992	VUMON	teniposide	HQ SPECLT PHARMA	NDA020119
July 3, 1992	ORTHO TRI-CYCLEN	ethinyl estradiol, norgestimate	JANSSEN PHARMS	NDA019697
June 19, 1992	HIVID	zalcitabine	ROCHE	NDA020199
June 19, 1992	PROSCAR	finasteride	ORGANON	NDA020180
June 17, 1992	LIORESAL	baclofen	AMNEAL	NDA020075
June 11, 1992	RBC-SCAN	technetium tc-99m red blood cell kit	CADEMA	NDA020063
June 8, 1992	NICORETTE	nicotine polacrilex	HALEON US HOLDINGS	NDA020066
May 29, 1992	DILACOR XR	diltiazem hydrochloride	ALLERGAN	NDA020092
May 19, 1992	LOTENSIN HCT	benazepril hydrochloride, hydrochlorothiazide	VALIDUS PHARMS	NDA020033
May 5, 1992	PROLEUKIN	aldesleukin	CHIRON	BLA103293
April 23, 1992	VENTOLIN	albuterol sulfate	GLAXOSMITHKLINE	NDA019773
April 21, 1992	SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER	sodium lactate	B BRAUN	NDA020004
April 17, 1992	DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER	calcium chloride, dextrose, potassium chloride, sodium chloride	B BRAUN	NDA020000
April 17, 1992	GLYBURIDE (MICRONIZED)	glyburide	SANOFI AVENTIS US	NDA020055
April 17, 1992	RINGER'S IN PLASTIC CONTAINER	calcium chloride, potassium chloride, sodium chloride	B BRAUN	NDA020002
April 8, 1992	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	lidocaine hydrochloride	B BRAUN	NDA019830
March 31, 1992	FLOXIN	ofloxacin	ORTHO MCNEIL PHARM	NDA020087
March 4, 1992	GLYNASE	glyburide	PFIZER	NDA020051
February 21, 1992	CARDENE SR	nicardipine hydrochloride	CHIESI	NDA020005
February 21, 1992	MAXAQUIN	lomefloxacin hydrochloride	PHARMACIA	NDA020013
February 19, 1992	TORNALATE	bitolterol mesylate	SANOFI AVENTIS US	NDA019548
February 14, 1992	SODIUM THIOSULFATE	sodium thiosulfate	US ARMY	NDA020166
January 31, 1992	ASACOL	mesalamine	APIL	NDA019651
January 30, 1992	CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER	nicardipine hydrochloride	CHIESI	NDA019734
January 30, 1992	PAREMYD	hydroxyamphetamine hydrobromide, tropicamide	EPIC PHARMA LLC	NDA019261
January 29, 1992	MINIPRESS XL	prazosin hydrochloride	PFIZER	NDA019775
January 28, 1992	PROSTEP	nicotine	AVEVA	NDA019983
January 22, 1992	MIVACRON	mivacurium chloride	ABBVIE	NDA020098
January 10, 1992	TOPROL-XL	metoprolol succinate	MELINTA THERAP	NDA019962