All FDA drug approvals

FDA data · free, no account

FDA drug approvals in 1998

FDA approved the original submission of 102 new drug and biologics license applications in 1998, from 75 sponsors. FDA marks 43 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

ApprovedBrandIngredientSponsorApplication
CELEBREXcelecoxibUPJOHNNDA020998
PROVIGILmodafinilNUVO PHARMSNDA020717
CHILDREN'S ADVILibuprofenHALEON US HOLDINGSNDA020944
TROVAN/ZITHROMAX COMPLIANCE PAKazithromycin dihydrate, trovafloxacin mesylatePFIZERNDA050762
ZIAGENabacavir sulfateVIIV HLTHCARENDA020977
ZIAGENabacavir sulfateVIIV HLTHCARENDA020978
DITROPAN XLoxybutynin chlorideJANSSEN PHARMSNDA020897
PROMETRIUMprogesteroneVIRTUS PHARMSNDA020843
EPIVIR-HBVlamivudineGLAXOSMITHKLINENDA021003
EPIVIR-HBVlamivudineGLAXOSMITHKLINENDA021004
THYROGENthyrotropin alfaGENZYMEBLA020898
SANDOSTATIN LARoctreotide acetateNOVARTISNDA021008
VERELAN PMverapamil hydrochlorideAZURITYNDA020943
GYNE-LOTRIMIN 3clotrimazoleBAYER HEALTHCARE LLCNDA020574
METROLOTIONmetronidazoleGALDERMA LABS LPNDA020901
ROCALTROLcalcitriolESJAY PHARMANDA021068
ACTIVELLAestradiol, norethindrone acetateAMNEALNDA020907
MICARDIStelmisartanBOEHRINGER INGELHEIMNDA020850
ACTIQfentanyl citrateCEPHALONNDA020747
ENBRELetanerceptIMMUNEXBLA103795
RENAGELsevelamer hydrochlorideGENZYMENDA020926
SONORXsimethicone-celluloseBRACCONDA020773
ROXICODONEoxycodone hydrochlorideROXANENDA020932
TOPAMAX SPRINKLEtopiramateJANSSEN PHARMSNDA020844
TIMOLOL MALEATEtimolol maleateSANDOZNDA020963
VERSEDmidazolam hydrochlorideROCHENDA020942
NEURONTINgabapentinVIATRISNDA020882
PAXILparoxetine hydrochlorideAPOTEXNDA020885
CELLCEPTmycophenolate mofetilROCHE PALONDA050759
PERIOSTATdoxycycline hyclateCOLLAGENEXNDA050744
HERCEPTINtrastuzumabGENENTECHBLA103792
VALSTAR PRESERVATIVE FREEvalrubicinENDO OPERATIONSNDA020892
PEPCID ACfamotidineKENVUE BRANDSNDA020801
AREDIApamidronate disodiumNOVARTISNDA020927
SUSTIVAefavirenzBRISTOL MYERS SQUIBBNDA020972
ACUTECTtechnetium tc-99m apcitideCIS BIO INTL SANDA020887
GLUCAGONglucagonLILLYNDA020928
VIRAMUNEnevirapineBOEHRINGER INGELHEIMNDA020933
ARAVAleflunomideSANOFI AVENTIS USNDA020905
ATRIDOXdoxycycline hyclateDEN-MATNDA050751
PREVEN EMERGENCY CONTRACEPTIVE KITethinyl estradiol, levonorgestrelTEVA BRANDED PHARMNDA020946
PROSOL 20% SULFITE FREE IN PLASTIC CONTAINERamino acidsBAXTER HLTHCARENDA020849
VITRAVENE PRESERVATIVE FREEfomivirsen sodiumNOVARTISNDA020961
LAMICTAL CDlamotrigineGLAXOSMITHKLINE LLCNDA020764
REMICADEinfliximabCENTOCOR INCBLA103772
CELLCEPTmycophenolate mofetil hydrochlorideROCHE PALONDA050758
COMBIPATCHestradiol, norethindrone acetateNOVEN PHARMS INCNDA020870
ESCLIMestradiolWOMEN FIRST HLTHCARENDA020847
CELEXAcitalopram hydrobromideABBVIENDA020822
THALOMIDthalidomideBRISTOL-MYERSNDA020785
LEVLITEethinyl estradiol, levonorgestrelBAYER HLTHCARENDA020860
AMOXILamoxicillinUS ANTIBIOTICSNDA050754
INFASURF PRESERVATIVE FREEcalfactantONYBLA020521
MAXALTrizatriptan benzoateORGANON LLCNDA020864
MAXALT-MLTrizatriptan benzoateORGANONNDA020865
GLUCAGENglucagon hydrochlorideNOVO NORDISKNDA020918
PRIFTINrifapentineSANOFI AVENTIS USNDA021024
SYNAGISpalivizumabSWEDISH ORPHANBLA103770
SULFAMYLONmafenide acetateMYLAN INSTITUTIONALNDA019832
ATACANDcandesartan cilexetilANI PHARMSNDA020838
REBETOLribavirinMERCK SHARP DOHMENDA020903
OPTIRAY 300ioversolLIEBEL-FLARSHEIMNDA020923
PEPCID RPDfamotidineMERCKNDA020752
INTEGRILINeptifibatideMSD SUB MERCKNDA020718
PERIOCHIPchlorhexidine gluconateDEXCEL PHARMANDA020774
AGGRASTATtirofiban hydrochlorideMEDICURENDA020912
AGGRASTATtirofiban hydrochlorideMEDICURENDA020913
PROMETRIUMprogesteroneACERTIS PHARMSNDA019781
SIMULECTbasiliximabNOVARTISBLA103764
STERANEprednisolone acetatePFIZERNDA011446
RETAVASEreteplaseEKR THERAPBLA103786
DICLOFENAC SODIUMdiclofenac sodiumFALCON PHARMSNDA020809
XELODAcapecitabineCHEPLAPHARMNDA020896
LAMISILterbinafineKARO HLTHCARENDA020846
MIRCETTEdesogestrel, ethinyl estradiolTEVA BRANDED PHARMNDA020713
ZEMPLARparicalcitolABBVIENDA020819
SUCRAIDsacrosidaseQOL MEDCLBLA020772
COSOPTdorzolamide hydrochloride, timolol maleateTHEA PHARMANDA020869
AZOPTbrinzolamideSANDOZNDA020816
CILOXANciprofloxacin hydrochlorideSANDOZNDA020369
MONISTAT 3miconazole nitrateMEDTECH PRODUCTSNDA020827
ACTONELrisedronate sodiumAPILNDA020835
VIAGRAsildenafil citrateVIATRISNDA020895
DETROLtolterodine tartrateUPJOHNNDA020771
ALREXloteprednol etabonateBAUSCH AND LOMBNDA020803
LOTEMAXloteprednol etabonateBAUSCH AND LOMBNDA020583
LOTEMAXloteprednol etabonatePHARMOSNDA020841
DIOVAN HCThydrochlorothiazide, valsartanNOVARTISNDA020818
ETOPOPHOS PRESERVATIVE FREEetoposide phosphateBRISTOL MYERS SQUIBBNDA020906
ZANTAC 75ranitidine hydrochlorideCHATTEM SANOFINDA020745
ZOSYN IN PLASTIC CONTAINERpiperacillin sodium, tazobactam sodiumBAXTER HLTHCARE CORPNDA050750
SINGULAIRmontelukast sodiumORGANONNDA020829
SINGULAIRmontelukast sodiumORGANONNDA020830
AMERGEnaratriptan hydrochlorideGLAXOSMITHKLINE LLCNDA020763
CIPRO HCciprofloxacin hydrochloride, hydrocortisoneSANDOZNDA020805
EMLAlidocaine, prilocaineASTRAZENECANDA020962
DAUNORUBICIN HYDROCHLORIDEdaunorubicin hydrochlorideHIKMANDA050731
INFANT'S ADVILibuprofenHALEON US HOLDINGSNDA020812
AVITAtretinoinRISINGNDA020400
TASMARtolcaponeBAUSCHNDA020697
EXCEDRIN (MIGRAINE RELIEF)acetaminophen, aspirin, caffeineHALEON US HOLDINGSNDA020802
LIPOSYN III 30%soybean oilHOSPIRANDA020181