All FDA drug approvals

FDA data · free, no account

FDA drug approvals in 2000

FDA approved the original submission of 105 new drug and biologics license applications in 2000, from 77 sponsors. FDA marks 39 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

ApprovedBrandIngredientSponsorApplication
DETROL LAtolterodine tartrateUPJOHNNDA021228
STARLIXnateglinideNOVARTISNDA021204
BENZACLINbenzoyl peroxide, clindamycin phosphateBAUSCHNDA050756
BUSPARbuspirone hydrochlorideBRISTOL MYERS SQUIBBNDA021190
CYCLESSAdesogestrel, ethinyl estradiolASPEN GLOBAL INCNDA021090
ANGIOMAXbivalirudinSANDOZNDA020873
TAMIFLUoseltamivir phosphateROCHENDA021246
LOTRISONEbetamethasone dipropionate, clotrimazoleMERCK SHARP DOHMENDA020010
MYOBLOCbotulinum toxin type bELAN PHARMBLA103846
PROTOPICtacrolimusLEO PHARMA ASNDA050777
MIRENAlevonorgestrelBAYER HLTHCARENDA021225
IMODIUM MULTI-SYMPTOM RELIEFloperamide hydrochloride, simethiconeKENVUE BRANDSNDA021140
AKTIPAKbenzoyl peroxide, erythromycinBIOFRONTERANDA050769
CLINDAGELclindamycin phosphateBAUSCHNDA050782
MICARDIS HCThydrochlorothiazide, telmisartanBOEHRINGER INGELHEIMNDA021162
TRIZIVIRabacavir sulfate, lamivudine, zidovudineVIIV HLTHCARENDA021205
VENOFERiron sucroseAM REGENTNDA021135
VIDEX ECdidanosineBRISTOL MYERS SQUIBBNDA021183
CARACfluorouracilEXTROVISNDA020985
PEPCID COMPLETEcalcium carbonate, famotidine, magnesium hydroxideKENVUE BRANDSNDA020958
SOLARAZEdiclofenac sodiumFOUGERANDA021005
GLUCOPHAGE XRmetformin hydrochlorideEMD SERONO INCNDA021202
NOVANTRONEmitoxantrone hydrochlorideSERONO INCNDA021120
NEURONTINgabapentinPARKE DAVISNDA021216
LESCOL XLfluvastatin sodiumSANDOZNDA021192
LUNELLEestradiol cypionate, medroxyprogesterone acetatePHARMACIA AND UPJOHNNDA020874
FLOVENT DISKUS 250fluticasone propionateGLAXO GRP LTDNDA020833
TAZORACtazaroteneALMIRALLNDA021184
MIFEPREXmifepristoneDANCO LABS LLCNDA020687
TRISENOXarsenic trioxideCEPHALONNDA021248
VISICOLsodium phosphate, dibasic, anhydrous, sodium phosphate, monobasic, monohydrateSALIX PHARMSNDA021097
OVIDRELchoriogonadotropin alfaEMD SERONOBLA021149
KALETRAlopinavir, ritonavirABBVIENDA021226
KALETRAlopinavir, ritonavirABBVIENDA021251
QVAR 80beclomethasone dipropionateTEVA BRANDED PHARMNDA020911
ATACAND HCTcandesartan cilexetil, hydrochlorothiazideANI PHARMSNDA021093
RENOVAtretinoinVALEANT PHARMS NORTHNDA021108
ROXICODONEoxycodone hydrochlorideSPECGX LLCNDA021011
RAPAMUNEsirolimusPF PRISM CVNDA021110
ADVAIR DISKUS 500/50fluticasone propionate, salmeterol xinafoateGLAXO GRP LTDNDA021077
UNITHROIDlevothyroxine sodiumSTEVENS JNDA021210
AZULFIDINE EN-TABSsulfasalazinePHARMACIA UPJOHNNDA021243
QUIXINlevofloxacinSANTENNDA021199
VIVELLEestradiolNOVARTISNDA021167
CETROTIDEcetrorelix acetateEMD SERONO INCNDA021197
PULMICORT RESPULESbudesonideASTRAZENECANDA020929
DEPAKOTE ERdivalproex sodiumABBVIENDA021168
RESCULAunoprostone isopropylSUCAMPO PHARMA LLCNDA021214
CHILDREN'S MOTRIN COLDibuprofen, pseudoephedrine hydrochlorideKENVUE BRANDSNDA021128
CONCERTAmethylphenidate hydrochlorideJANSSEN PHARMSNDA021121
GLUCOVANCEglyburide, metformin hydrochlorideBRISTOL MYERS SQUIBBNDA021178
CEFAZOLIN AND DEXTROSEcefazolin sodiumB BRAUNNDA050779
VANIQAeflornithine hydrochlorideABBVIENDA021145
ABREVAdocosanolHALEON US HOLDINGSNDA020941
COLAZALbalsalazide disodiumVALEANT PHARMS INTLNDA020610
CHLORAPREP ONE-STEPchlorhexidine gluconate, isopropyl alcoholBECTON DICKINSON CONDA020832
INNOHEPtinzaparin sodiumLEO PHARMA ASNDA020484
MALARONE PEDIATRICatovaquone, proguanil hydrochlorideGLAXOSMITHKLINENDA021078
RENAGELsevelamer hydrochlorideGENZYMENDA021179
ARGATROBANargatrobanSANDOZNDA020883
TARGRETINbexaroteneBAUSCHNDA021056
NORDITROPIN FLEXPROsomatropinNOVO NORDISK INCBLA021148
TRELSTARtriptorelin pamoateVERITYNDA020715
NOVOLOG PENFILLinsulin aspart recombinantNOVO NORDISK INCBLA020986
TNKASEtenecteplaseGENENTECHBLA103909
DIFFERINadapaleneGALDERMA LABS LPNDA020748
OLUXclobetasol propionateQUAGENNDA021142
WELCHOLcolesevelam hydrochlorideCOSETTENDA021141
WELCHOLcolesevelam hydrochlorideCOSETTENDA021176
OPTIVARazelastine hydrochlorideRISINGNDA021127
INFUVITE ADULTalpha-tocopherol acetate, ascorbic acid, biotin, cholecalciferol, cyanocobalamin, dexpanthenol, folic acid, niacinamide, pyridoxine hydrochloride, riboflavin 5'-phosphate sodium, thiamine hydrochloride, vitamin a palmitate, vitamin kSANDOZ CANADA INCNDA021163
NITROSTATnitroglycerinVIATRISNDA021134
EXELONrivastigmine tartrateNOVARTISNDA020823
EXELONrivastigmine tartrateNOVARTISNDA021025
LANTUS SOLOSTARinsulin glargine recombinantSANOFI AVENTIS USBLA021081
ZYVOXlinezolidPFIZERNDA021130
ZYVOXlinezolidPFIZERNDA021131
ZYVOXlinezolidPFIZERNDA021132
MOBICmeloxicamBOEHRINGER INGELHEIMNDA020938
TRIVAGIZOLE 3clotrimazoleSUN PHARMA CANADANDA021143
VISUDYNEverteporfinBAUSCH LOMB IRELANDNDA021119
ACTIVELLAestradiol, norethindrone acetateNOVO NORDISKNDA021103
HECTOROLdoxercalciferolSANOFINDA021027
ZYPREXA ZYDISolanzapineCHEPLAPHARMNDA021086
SEPTOCAINEarticaine hydrochloride, epinephrine bitartrateDEPROCONDA020971
ZONEGRANzonisamideADVANZ PHARMANDA020789
LAMISIL ATterbinafine hydrochlorideKARO HLTHCARENDA021124
MAGNEVISTgadopentetate dimeglumineBAYER HLTHCARENDA021037
RID MOUSSEpiperonyl butoxide, pyrethrinsBAYER HEALTHCARE LLCNDA021043
BIAXIN XLclarithromycinABBVIENDA050775
VIADURleuprolide acetateORTHO MCNEIL JANSSENNDA021088
NEURONTINgabapentinVIATRISNDA021129
ANDROGELtestosteroneBESINS HLTHCARENDA021015
ALLEGRA HIVESfexofenadine hydrochlorideCHATTEM SANOFINDA020872
BETAXONlevobetaxolol hydrochlorideALCON PHARMS LTDNDA021114
BETAPACE AFsotalol hydrochlorideLEGACYNDA021151
SKIN EXPOSURE REDUCTION PASTE AGAINST CHEMICAL WARFARE AGENTSperfluoropolymethylisopropyl ether, polytetrafluoroethyleneUS ARMY MED RESNDA021084
LOTRONEXalosetron hydrochlorideLEGACYNDA021107
ALLERNAZEtriamcinolone acetonideLUPIN ATLANTISNDA020120
PROTONIXpantoprazole sodiumWYETH PHARMSNDA020987
CALCIUM CHLORIDE 10% IN PLASTIC CONTAINERcalcium chlorideHOSPIRANDA021117
DILTIAZEM HYDROCHLORIDEdiltiazem hydrochlorideBIOVAILNDA020939
PRIMSOLtrimethoprim hydrochloridePANGEANDA074973
TRILEPTALoxcarbazepineNOVARTISNDA021014
EVOXACcevimeline hydrochlorideCOSETTENDA020989