All FDA drug approvals

FDA data · free, no account

FDA drug approvals in 1995

FDA approved the original submission of 89 new drug and biologics license applications in 1995, from 59 sponsors. FDA marks 43 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

ApprovedBrandIngredientSponsorApplication
NUTROPIN AQ PENsomatropinGENENTECHBLA020522
RENOVAtretinoinVALEANT PHARMS NORTHNDA019963
CORVERTibutilide fumaratePFIZERNDA020491
ARIMIDEXanastrozoleANI PHARMSNDA020541
PHOTOFRINporfimer sodiumPINNACLE BIOLGSNDA020451
LUPRON DEPOTleuprolide acetateABBVIE ENDOCRINE INCNDA020517
FEMSTAT 3butoconazole nitrateBAYERNDA020421
IONTOCAINEepinephrine, lidocaine hydrochlorideIOMEDNDA020530
OXILAN-350ioxilanGUERBETNDA020316
CEDAXceftibuten dihydrateBURKE THERAPNDA050685
CEDAXceftibuten dihydrateBURKE THERAPNDA050686
RETROVIRzidovudineVIIV HLTHCARENDA020518
ZANTAC 75ranitidine hydrochlorideCHATTEM SANOFINDA020520
ZOLADEXgoserelinTERSERANDA020515
NIMBEX PRESERVATIVE FREEcisatracurium besylateABBVIENDA020551
VALTREXvalacyclovir hydrochlorideGLAXOSMITHKLINENDA020550
RILUTEKriluzoleAZURITYNDA020599
ETHYOLamifostineLEGACYNDA020221
ZYRTEC HIVEScetirizine hydrochlorideKENVUE BRANDSNDA019835
INVIRASEsaquinavir mesylateHOFFMANN LA ROCHENDA020628
AMARYLglimepirideSANOFI AVENTIS USNDA020496
VESANOIDtretinoinCHEPLAPHARMNDA020438
ABELCETamphotericin bLEADIANT BIOSCI INCNDA050724
DOXIL (LIPOSOMAL)doxorubicin hydrochlorideBAXTER HLTHCARE CORPNDA050718
EPIVIRlamivudineVIIV HLTHCARENDA020564
EPIVIRlamivudineVIIV HLTHCARENDA020596
PREMPROestrogens, conjugated, medroxyprogesterone acetateWYETH PHARMSNDA020527
TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINERamino acids, magnesium chloride, potassium phosphate, dibasic, sodium acetate, sodium chlorideBAXTER HLTHCARENDA020173
OMNIPAQUE 350iohexolGE HEALTHCARENDA020608
TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINERamino acids, magnesium chloride, potassium phosphate, dibasic, sodium acetate, sodium chlorideBAXTER HLTHCARENDA020177
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINERamino acids, dextrose, magnesium chloride, potassium phosphate, dibasic, sodium acetate, sodium chlorideBAXTER HLTHCARENDA020147
ATROVENTipratropium bromideBOEHRINGER INGELHEIMNDA020393
ATROVENTipratropium bromideBOEHRINGER INGELHEIMNDA020394
ZITHROMAXazithromycinPFIZERNDA050710
ACTRONketoprofenBAYERNDA020499
ORUDIS KTketoprofenWYETH CONSNDA020429
CASODEXbicalutamideANI PHARMSNDA020498
ANDRODERMtestosteroneABBVIENDA020489
FOSAMAXalendronate sodiumORGANONNDA020560
DEXTROSE 5% IN PLASTIC CONTAINERdextroseDHLNDA019971
FLOLANepoprostenol sodiumGLAXOSMITHKLINE LLCNDA020444
METROCREAMmetronidazoleGALDERMA LABS LPNDA020531
BACTROBANmupirocin calciumGLAXOSMITHKLINENDA050703
PROPULSIDcisapride monohydrateJANSSEN PHARMSNDA020398
COREGcarvedilolWAYLIS THERAPNDA020297
AZELEXazelaic acidALMIRALLNDA020428
TIAZACdiltiazem hydrochlorideBAUSCHNDA020401
DDAVPdesmopressin acetateFERRING PHARMS INCNDA019955
PRECOSEacarboseBAYER HLTHCARENDA020482
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5%dopamine hydrochlorideHOSPIRANDA020542
GENOTROPIN PRESERVATIVE FREEsomatropinPHARMACIABLA020280
MIACALCINcalcitonin salmonSAPTALIS PHARMSNDA020313
CORDARONEamiodarone hydrochlorideWYETH PHARMS INCNDA020377
NEORALcyclosporineNOVARTISNDA050715
NEORALcyclosporineNOVARTISNDA050716
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINERmagnesium sulfateHOSPIRANDA020488
CAVERJECTalprostadilPFIZERNDA020379
PRIMSOLtrimethoprim hydrochloridePANGEANDA074374
VALTREXvalacyclovir hydrochlorideGLAXOSMITHKLINENDA020487
DYNABACdirithromycinLILLY RES LABSNDA050678
TAGAMET HBcimetidineMEDTECH PRODUCTSNDA020238
CHILDREN'S MOTRINibuprofenKENVUE BRANDSNDA020516
ULTANEsevofluraneABBVIENDA020478
IMITREXsumatriptan succinateGLAXOSMITHKLINENDA020132
ZINECARDdexrazoxane hydrochloridePFIZERNDA020212
MOTRINibuprofenMCNEILNDA020476
ZOMACTONsomatropinFERRINGBLA019774
ADENOSCANadenosineASTELLASNDA020059
PREVACIDlansoprazoleTAKEDA PHARMS USANDA020406
ULTRAVIST 150iopromideBAYER HLTHCARENDA020220
CELLCEPTmycophenolate mofetilROCHE PALONDA050722
FLAGYLmetronidazolePFIZERNDA020334
HYZAARhydrochlorothiazide, losartan potassiumORGANONNDA020387
PEPCID ACfamotidineKENVUE BRANDSNDA020325
ADVIL LIQUI-GELSibuprofenHALEON US HOLDINGSNDA020402
UNIVASCmoexipril hydrochlorideUCB INCNDA020312
REVEXnalmefene hydrochlorideHIKMANDA020459
COZAARlosartan potassiumORGANONNDA020386
BETIMOLtimololTHEA PHARMANDA020439
CERVIDILdinoprostoneFERRING PHARMS INCNDA020411
LUPRON DEPOTleuprolide acetateABBVIE ENDOCRINE INCNDA019943
KYTRILgranisetron hydrochlorideROCHENDA020305
NASARELflunisolideTEVA BRANDED PHARMNDA020409
GLUCOPHAGEmetformin hydrochlorideEMD SERONO INCNDA020357
LOTRELamlodipine besylate, benazepril hydrochlorideSANDOZNDA020364
ULTRAMtramadol hydrochlorideJANSSEN PHARMSNDA020281
MEPRONatovaquoneGLAXOSMITHKLINE LLCNDA020500
SULARnisoldipineAZURITYNDA020356
ZOFRAN AND DEXTROSE IN PLASTIC CONTAINERondansetron hydrochlorideGLAXOSMITHKLINENDA020403