All FDA drug approvals

FDA data · free, no account

FDA drug approvals in 2005

FDA approved the original submission of 83 new drug and biologics license applications in 2005, from 67 sponsors. FDA marks 32 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

ApprovedBrandIngredientSponsorApplication
VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINERconivaptan hydrochlorideAPOTEXNDA021697
CLIMARA PROestradiol, levonorgestrelBERLEX LABSNDA021885
REVLIMIDlenalidomideBRISTOL MYERS SQUIBBNDA021880
ORENCIAabataceptBRISTOL MYERS SQUIBBBLA125118
ADVIL PMdiphenhydramine hydrochloride, ibuprofenHALEON US HOLDINGSNDA021393
ADVIL PMdiphenhydramine citrate, ibuprofenHALEON US HOLDINGSNDA021394
CITALOPRAM HYDROBROMIDEcitalopram hydrobromideBIOVAIL LABS INTLNDA021763
IPLEXmecasermin rinfabate recombinantINSMEDBLA021884
HYLENEX RECOMBINANThyaluronidase recombinant humanHALOZYME THERAPBLA021859
NEXAVARsorafenib tosylateBAYER HLTHCARENDA021923
AVANDARYLglimepiride, rosiglitazone maleateSB PHARMCONDA021700
EXJADEdeferasiroxNOVARTISNDA021882
SOLTAMOXtamoxifen citrateMAYNE PHARMA COMMRCLNDA021807
ARRANONnelarabineSANDOZNDA021877
KALETRAlopinavir, ritonavirABBVIENDA021906
CLOBEXclobetasol propionateGALDERMA LABS LPNDA021835
HYDASEhyaluronidaseAKORN INCBLA021716
LEVEMIRinsulin detemirNOVO NORDISKBLA021878
LORATADINEloratadineSUN PHARMA CANADANDA021734
ANGELIQdrospirenone, estradiolBAYER HLTHCARENDA021355
EMTRIVAemtricitabineGILEADNDA021896
ULTRAM ERtramadol hydrochlorideVALEANT PHARMSNDA021692
AMBIEN CRzolpidem tartrateCOSETTENDA021774
INCRELEXmecasermin recombinantIPSEN INCBLA021839
ACTOPLUS METmetformin hydrochloride, pioglitazone hydrochlorideTAKEDA PHARMS USANDA021842
FOLLISTIM AQfollitropin alfa/betaORGANON USA INCBLA021273
ALPHAGAN Pbrimonidine tartrateABBVIENDA021770
FLUDEOXYGLUCOSE F18fludeoxyglucose f-18FEINSTEINNDA021870
NEVANACnepafenacHARROW EYENDA021862
ACTONEL WITH CALCIUM (COPACKAGED)calcium carbonate, risedronate sodiumWARNER CHILCOTTNDA021823
FORTICALcalcitonin salmon recombinantUPSHER SMITH LABSNDA021406
QUALAQUINquinine sulfateSUN PHARM INDUSTRIESNDA021799
LOPERAMIDE HYDROCHLORIDEloperamide hydrochlorideBIONPHARMANDA021855
ROZEREMramelteonTAKEDA PHARMS USANDA021782
ACZONEdapsoneALMIRALLNDA021794
MEGACE ESmegestrol acetateENDO OPERATIONSNDA021778
METROGELmetronidazoleGALDERMA LABS LPNDA021789
BIDILhydralazine hydrochloride, isosorbide dinitrateAZURITYNDA020727
SYNERAlidocaine, tetracaineGALEN SPECIALTYNDA021623
APTIVUStipranavirBOEHRINGER INGELHEIMNDA021814
ALINIAnitazoxanideROMARKNDA021818
LEVEMIR FLEXTOUCHinsulin detemir recombinantNOVO NORDISK INCBLA021536
TYGACILtigecyclinePF PRISM CVNDA021821
LYRICApregabalinCP PHARMSNDA021724
REGLAN ODTmetoclopramide hydrochlorideMEDA PHARMSNDA021793
ZMAXazithromycinPF PRISM CVNDA050797
GLUMETZAmetformin hydrochlorideSANTARUS INCNDA021748
PREVANTICS SWABSTICKchlorhexidine gluconate, isopropyl alcoholPROF DSPLSNDA021524
REVATIOsildenafil citrateVIATRISNDA021845
NAGLAZYMEgalsulfaseBIOMARINBLA125117
FOCALIN XRdexmethylphenidate hydrochlorideSANDOZNDA021802
ZEMPLARparicalcitolABBVIENDA021606
VANDAZOLEmetronidazoleTEVA PHARMSNDA021806
PROQUIN XRciprofloxacin hydrochlorideDEPOMED INCNDA021744
ORTHO TRI-CYCLEN 28ethinyl estradiol, norgestimateORTHO MCNEIL PHARMNDA021690
TRIGLIDEfenofibrateJAGOTECNDA021350
DORYX MPCdoxycycline hyclateMAYNE PHARMANDA050795
RYBIX ODTtramadol hydrochlorideSHIONOGI INCNDA021693
BYETTAexenatide syntheticASTRAZENECA ABNDA021773
CHLORHEXIDINE GLUCONATEchlorhexidine gluconateSAGE PRODSNDA021669
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINERceftriaxone sodiumB BRAUNNDA050796
NAMENDAmemantine hydrochlorideALLERGANNDA021627
RETISERTfluocinolone acetonideBAUSCH AND LOMBNDA021737
FOSAMAX PLUS Dalendronate sodium, cholecalciferolORGANON LLCNDA021762
RAZADYNE ERgalantamine hydrobromideJANSSEN PHARMSNDA021615
CUTIVATEfluticasone propionateFOUGERANDA021152
NEXIUM IVesomeprazole sodiumASTRAZENECANDA021689
ASMANEX TWISTHALERmometasone furoateORGANON LLCNDA021067
BARACLUDEentecavirBRISTOL MYERS SQUIBBNDA021797
BARACLUDEentecavirBRISTOL MYERS SQUIBBNDA021798
BROMDAYbromfenac sodiumBAUSCH AND LOMB INCNDA021664
MYCAMINEmicafungin sodiumASTELLASNDA021506
MYCAMINEmicafungin sodiumFUJISAWA HLTHCARENDA021754
SYMLINpramlintide acetateASTRAZENECA ABNDA021332
XOPENEX HFAlevalbuterol tartrateLUPINNDA021730
CLARINEX D 24 HOURdesloratadine, pseudoephedrine sulfateORGANONNDA021605
CARDURA XLdoxazosin mesylateVIATRISNDA021269
AMMONULsodium benzoate, sodium phenylacetateBAUSCHNDA020645
VANOSfluocinonideBAUSCHNDA021758
ELOXATINoxaliplatinSANOFI AVENTIS USNDA021759
NASCOBALcyanocobalaminENDO OPERATIONSNDA021642
NIRAVAMalprazolamUCB INCNDA021726
ABRAXANEpaclitaxelBRISTOL-MYERSNDA021660