All FDA drug approvals

FDA data · free, no account

FDA drug approvals in 1991

FDA approved the original submission of 64 new drug and biologics license applications in 1991, from 48 sponsors. FDA marks 42 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

ApprovedBrandIngredientSponsorApplication
LORABIDloracarbefKING PHARMSNDA050667
LORABIDloracarbefKING PHARMSNDA050668
PENETREXenoxacinSANOFI AVENTIS USNDA019616
TRIOSTATliothyronine sodiumPH HEALTHNDA020105
ISMOisosorbide mononitratePROMIUS PHARMANDA019091
ZOLOFTsertraline hydrochlorideVIATRISNDA019839
CARDIZEM CDdiltiazem hydrochlorideBAUSCHNDA020062
MACROBIDnitrofurantoin, nitrofurantoin, macrocrystallineALMATICANDA020064
RELAFENnabumetoneSMITHKLINE BEECHAMNDA019583
SUPPRELINhistrelin acetateSHIRENDA019836
CEFZILcefprozilCORDEN PHARMANDA050664
CEFZILcefprozilCORDEN PHARMANDA050665
ZOCORsimvastatinORGANONNDA019766
ROMAZICONflumazenilHOFFMANN LA ROCHENDA020073
TORADOLketorolac tromethamineROCHE PALONDA019645
AMINOSYN II 10% IN PLASTIC CONTAINERamino acidsOTSUKA ICU MEDCLNDA020015
AMINOSYN II 15% IN PLASTIC CONTAINERamino acidsOTSUKA ICU MEDCLNDA020041
STADOLbutorphanol tartrateBRISTOL MYERS SQUIBBNDA019890
BOTOX COSMETIConabotulinumtoxinaALLERGANBLA103000
HABITROLnicotineDR REDDYS LABS SANDA020076
METHOTREXATE SODIUMcalcium chloride, dextrose, glutathione disulfide, magnesium chloride, potassium chloride, sodium bicarbonate, sodium chloride, sodium phosphateEPIC PHARMA LLCNDA020079
ACCUPRILquinapril hydrochloridePFIZER PHARMSNDA019885
NICODERM CQnicotineCHATTEM SANOFINDA020165
ENLON-PLUSatropine sulfate, edrophonium chloridePHARMOBEDIENTNDA019677
ENLON-PLUSatropine sulfate, edrophonium chloridePHARMOBEDIENTNDA019678
ZITHROMAXazithromycinPFIZERNDA050670
AREDIApamidronate disodiumNOVARTISNDA020036
BIAXINclarithromycinABBVIENDA050662
PRAVACHOLpravastatin sodiumBRISTOL MYERS SQUIBBNDA019898
TICLIDticlopidine hydrochlorideROCHE PALONDA019979
CARDIZEMdiltiazem hydrochlorideBIOVAIL LABS INTLNDA020027
NIPENTpentostatinHOSPIRA INCNDA020122
VIDEXdidanosineBRISTOL MYERS SQUIBBNDA020154
VIDEXdidanosineBRISTOL MYERS SQUIBBNDA020155
VIDEXdidanosineBRISTOLNDA020156
FOSCAVIRfoscarnet sodiumCLINIGEN HLTHCARENDA020068
DERMATOPprednicarbateVALEANT PHARMS NORTHNDA019568
ORAMORPH SRmorphine sulfateXANODYNE PHARMS INCNDA019977
PLENDILfelodipineASTRAZENECANDA019834
NASACORTtriamcinolone acetonideCHATTEM SANOFINDA019798
DEXTROSE 60% IN PLASTIC CONTAINERdextroseBAXTER HLTHCARENDA020047
NOVOLIN Ninsulin susp isophane recombinant humanNOVO NORDISK INCBLA019959
SURVANTAberactantABBVIEBLA020032
LOTENSINbenazepril hydrochlorideVALIDUS PHARMSNDA019851
NOVOLIN 70/30insulin recombinant human, insulin susp isophane recombinant humanNOVO NORDISK INCBLA019991
NOVOLIN Rinsulin recombinant humanNOVO NORDISK INCBLA019938
CHIBROXINnorfloxacinMERCKNDA019757
ULTRATAGtechnetium tc-99m red blood cell kitCURIUMNDA019981
SINEMET CRcarbidopa, levodopaORGANON LLCNDA019856
MONOPRILfosinopril sodiumBRISTOL MYERS SQUIBBNDA019915
ZOVIRAXacyclovirPHARMOBEDIENTNDA020089
PROZACfluoxetine hydrochlorideLILLYNDA020101
NULYTELYpolyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chlorideAZURITYNDA019797
FLUDARAfludarabine phosphateGENZYME CORPNDA020038
VOLTARENdiclofenac sodiumNOVARTISNDA020037
NUROMAXdoxacurium chlorideABBVIENDA019946
LEUKINEsargramostimBERLEX LABSBLA103362
TERAZOL 3terconazoleJANSSEN PHARMSNDA019964
NEUPOGENfilgrastimAMGENBLA103353
LODINEetodolacWYETH PHARMS INCNDA018922
CHEMETsuccimerRECORDATI RARENDA019998
ALTACEramiprilKING PHARMS LLCNDA019901
GANITEgallium nitrateCHAPTER 7 TRUSTEENDA019961
ZOFRANondansetron hydrochlorideSANDOZNDA020007