All FDA drug approvals

FDA data · free, no account

FDA drug approvals in 2013

FDA approved the original submission of 152 new drug and biologics license applications in 2013, from 108 sponsors. FDA marks 22 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

ApprovedBrandIngredientSponsorApplication
ISENTRESSraltegravir potassiumMSD SUB MERCKNDA205786
ORENITRAMtreprostinil diolamineUNITED THERAPNDA203496
KUVANsapropterin dihydrochlorideBIOMARIN PHARMNDA205065
ADRENALINepinephrinePH HEALTHNDA204640
ANORO ELLIPTAumeclidinium bromide, vilanterol trifenatateGLAXOSMITHKLINENDA203975
SOVALDIsofosbuvirGILEAD SCIENCES INCNDA204671
VELPHOROferric oxyhydroxideVIFOR FRESENIUSNDA205109
NOXAFILposaconazoleMERCK SHARP DOHMENDA205053
VARITHENApolidocanolBOSTON SCITFCNDA205098
OLYSIOsimeprevir sodiumJANSSEN PRODSNDA205123
LUZUluliconazoleBAUSCHNDA204153
IMBRUVICAibrutinibPHARMACYCLICS LLCNDA205552
APTIOMeslicarbazepine acetateSUMITOMO PHARMA AMNDA022416
GAZYVAobinutuzumabGENENTECHBLA125486
MORPHINE SULFATEmorphine sulfateFRESENIUS KABI USANDA204223
VIZAMYLflutemetamol f-18GE HEALTHCARENDA203137
ZOHYDRO ERhydrocodone bitartrateRECRO GAINESVILLENDA202880
ECOZAeconazole nitrateRESILIA PHARMSNDA205175
ACTEMRAtocilizumabGENENTECHBLA125472
OPSUMITmacitentanACTELIONNDA204410
ZORVOLEXdiclofenacZYLANDA204592
DESVENLAFAXINEdesvenlafaxine fumarateTEVA PHARMS USANDA205208
OTREXUPmethotrexateCOSETTENDA204824
ADEMPASriociguatBAYER HLTHCARENDA204819
CLINOLIPID 20%olive oil, soybean oilBAXTER HLTHCARE CORPNDA204508
DUAVEEbazedoxifene acetate, estrogens, conjugatedWYETH PHARMSNDA022247
TRINTELLIXvortioxetine hydrobromideTAKEDA PHARMS USANDA204447
CYCLOPHOSPHAMIDEcyclophosphamideHIKMANDA203856
CARBON DIOXIDE, USPcarbon dioxideAIRGAS USA LLCNDA206025
HELIUM, USPheliumAIR LIQUIDE HEALTHCARE AMERICA CORPNDA206026
NITROGEN, NFnitrogenAIRGAS USA LLCNDA206024
OXYGEN, USPoxygenAIRGAS USA LLCNDA206023
NITROUS OXIDE, USPnitrous oxideNITROUS OXIDE OF CANADANDA206014
NITROUS OXIDE, USPnitrous oxideNITROUS OXIDE CORPNDA206009
MEDICAL AIR, USPmedical airACETYLENE OXYGENE CONDA205999
MEDICAL AIR, USPmedical airUNITED STATES WELDING INCNDA205992
NITROGEN, NFnitrogenPRAXAIR CANADA INCNDA205985
OXYGEN, USPoxygenPRAXAIR CANADA INCNDA205986
MIRVASObrimonidine tartrateGALDERMA LABS LPNDA204708
VALCHLORmechlorethamine hydrochlorideHELSINNNDA202317
TROKENDI XRtopiramateSUPERNUS PHARMSNDA201635
EPANED KITenalapril maleateAZURITYNDA204308
TIVICAYdolutegravir sodiumVIIV HLTHCARENDA204790
ESOMEPRAZOLE STRONTIUMesomeprazole strontiumBELCHERNDA202342
HELIUM, USPheliumPRAXAIR DISTRIBUTION MID-ATLANTIC LLCNDA205911
HELIUM, USPheliumPRAXAIR DISTRIBUTION INCNDA205912
MEDICAL AIR, USPmedical airPRAXAIR DISTRIBUTION INCNDA205909
MEDICAL AIR, USPmedical airPRAXAIR DISTRIBUTION MID-ATLANTIC LLCNDA205910
MEDICAL AIR, USPmedical airMATHESON TRI-GAS INCNDA205890
NITROGEN, NFnitrogenMATHESON TRI-GAS INCNDA205891
OXYGEN, USPoxygenMATHESON TRI-GAS INCNDA205889
ZOLEDRONIC ACIDzoledronic acidINFORLIFENDA203231
FETZIMAlevomilnacipran hydrochlorideABBVIENDA204168
INJECTAFERferric carboxymaltoseAM REGENTNDA203565
LO MINASTRIN FEethinyl estradiol, norethindrone acetateAPILNDA204654
MEDICAL AIR, USPmedical airNEXAIRNDA205859
NITROGEN, NFnitrogenASPEN AIRNDA205863
NITROGEN, NFnitrogenAIR PRODUCTS AND CHEMICALS INCNDA205866
OXYGEN, USPoxygenASPEN AIRNDA205862
OXYGEN, USPoxygenAIR PRODUCTS AND CHEMICALS INCNDA205865
CARBON DIOXIDE, USPcarbon dioxidePRAXAIR INCNDA205852
HELIUM, USPheliumPRAXAIR INCNDA205851
NITROGEN, NFnitrogenPRAXAIR INCNDA205850
OXYGEN, USPoxygenPRAXAIR INCNDA205849
CARBON DIOXIDE, USPcarbon dioxideAIRGAS CARBONIC INCNDA205846
HELIUM, USPheliumAIRGAS USA LLCNDA205843
MEDICAL AIR, USPmedical airAIRGAS USA LLCNDA205845
MEDICAL AIR, USPmedical airOXARC INCNDA205847
ASTAGRAF XLtacrolimusASTELLASNDA204096
SIMPONI ARIAgolimumabJANSSEN BIOTECHBLA125433
NITROGEN, NFnitrogenAIRGAS MERCHANTS GASES LLCNDA205839
OXYGEN, USPoxygenAIRGAS MERCHANTS GASES LLCNDA205840
MEDICAL AIR, USPmedical airDUPUY OXYGENNDA205826
HELIUM, USPheliumNORCO INCNDA205819
MEDICAL AIR, USPmedical airWYNN L MADER, INDUSTRIAL GAS DISTRIBUTORSNDA205803
MEDICAL AIR, USPmedical airPURITY CYLINDER GASES, INCNDA205804
MEDICAL AIR, USPmedical airWESTAIR GASES & EQUIPMENT INCNDA205809
MEDICAL AIR, USPmedical airSCOTT-GROSS COMPANYNDA205821
NITROGEN, NFnitrogenNORCO INCNDA205805
OXYGEN, USPoxygenNORCO INCNDA205820
MEDICAL AIR, USPmedical airMACHINE & WELDING SUPPLY CONDA205796
MEDICAL AIR, USPmedical airAIR LIQUIDE AMERICA LPNDA205828
NITROGEN, NFnitrogenAIR LIQUIDE AMERICA LPNDA205829
OXYGEN, USPoxygenAIR LIQUIDE AMERICA LPNDA205827
GILOTRIFafatinib dimaleateBOEHRINGER INGELHEIMNDA201292
KHEDEZLAdesvenlafaxineOSMOTICA PHARM CORPNDA204683
CARBON DIOXIDE, USPcarbon dioxideLINDE NORTH AMERICA INCNDA205764
CARBON DIOXIDE, USPcarbon dioxideLINDE MERCHANT PRODUCTIONS INCNDA205815
MEDICAL AIR, USPmedical airLINDE NORTH AMERICA INCNDA205765
NITROGEN, NFnitrogenLINDE NORTH AMERICA INCNDA205766
NITROGEN, NFnitrogenLINDE GAS PUERTO RICO INCNDA205816
OXYGEN, USPoxygenLINDE NORTH AMERICA INCNDA205767
OXYGEN, USPoxygenLINDE NORTH AMERICA INCNDA205817
OXYGEN, USPoxygenLINDE GAS PUERTO RICO INCNDA205818
ZUBSOLVbuprenorphine hydrochloride, naloxone hydrochlorideEDENBRIDGE PHARMSNDA204242
BRISDELLEparoxetine mesylateLEGACYNDA204516
NAFTINnaftifine hydrochlorideLEGACYNDA204286
NITROGEN, NFnitrogenAIR LIQUIDE LARGE INDUSTRIES US LPNDA205738
OXYGEN, USPoxygenAIR LIQUIDE LARGE INDUSTRIES US LPNDA205737
VIBATIVtelavancinTHERAVANCE INCNDA022407
ZEGERID OTComeprazole, sodium bicarbonateRILEY CONSUMERNDA022283
MEDICAL AIR, USPmedical airAIR LIQUIDE AMERICA SPECIALITY GASESNDA205711
NITROUS OXIDE, USPnitrous oxideAIR LIQUIDE AMERICA SPECIALITY GASESNDA205704
OXYGEN, USPoxygenAIR LIQUID INDUSTRIAL US LPNDA205712
OXYGEN, USPoxygenAIR LIQUID INDUSTRIAL US LPNDA205713
BLOXIVERZneostigmine methylsulfateEXELA PHARMANDA204078
MEKINISTtrametinib dimethyl sulfoxideNOVARTISNDA204114
TAFINLARdabrafenib mesylateNOVARTISNDA202806
XOFIGOradium ra-223 dichlorideBAYER HLTHCARENDA203971
BREO ELLIPTAfluticasone furoate, vilanterol trifenatateGLAXO GRP LTDNDA204275
NYMALIZEnimodipineAZURITYNDA203340
MINASTRIN 24 FEethinyl estradiol, norethindrone acetateAPILNDA203667
LIPTRUZETatorvastatin calcium, ezetimibeORGANONNDA200153
PROCYSBIcysteamine bitartrateHORIZONNDA203389
SIMBRINZAbrimonidine tartrate, brinzolamideALCON LABS INCNDA204251
TAYTULLAethinyl estradiol, norethindrone acetateAPILNDA204426
DOCETAXELdocetaxelACTAVISNDA203551
SITAVIGacyclovirLIGAND PHARMSNDA203791
TOPICORTdesoximetasoneSUN PHARMA CANADANDA204141
DICLEGISdoxylamine succinate, pyridoxine hydrochlorideDUCHESNAYNDA021876
PROLENSAbromfenac sodiumBAUSCH AND LOMBNDA203168
INVOKANAcanagliflozinJANSSEN PHARMSNDA204042
KARBINAL ERcarbinoxamine maleateAYTUNDA022556
QUARTETTEethinyl estradiol, levonorgestrelTEVA BRANDED PHARMNDA204061
TECFIDERAdimethyl fumarateBIOGENNDA204063
ACIPHEX SPRINKLErabeprazole sodiumAYTUNDA204736
TOBI PODHALERtobramycinVIATRISNDA201688
PHENYLEPHRINE HYDROCHLORIDEphenylephrine hydrochloridePARAGON BIOTECKNDA203510
DOTAREMgadoterate meglumineGUERBETNDA204781
LYMPHOSEEK KITtechnetium tc-99m tilmanoceptCARDINAL HEALTH 414NDA202207
DESVENLAFAXINEdesvenlafaxineALEMBIC PHARMS LTDNDA204150
ABILIFY MAINTENA KITaripiprazoleOTSUKA PHARM CO LTDNDA202971
OSPHENAospemifeneDUCHESNAYNDA203505
STIVARGAregorafenibBAYER HEALTHCARE PHARMSNDA204369
KADCYLAado-trastuzumab emtansineGENENTECHBLA125427
SUPRAXcefiximeLUPIN LTDNDA202091
VITUZchlorpheniramine maleate, hydrocodone bitartratePERSIONNDA204307
POMALYSTpomalidomideBRISTOLNDA204026
VERSACLOZclozapineDOUGLAS PHARMSNDA203479
DELZICOLmesalamineABBVIENDA204412
RAVICTIglycerol phenylbutyrateHORIZON THERAP USNDA203284
TESTOSTERONEtestosteronePERRIGO ISRAELNDA203098
KYNAMROmipomersen sodiumKASTLE THERAPS LLCNDA203568
KAZANOalogliptin benzoate, metformin hydrochlorideTAKEDA PHARMS USANDA203414
NESINAalogliptin benzoateTAKEDA PHARMS USANDA022271
OSENIalogliptin benzoate, pioglitazone hydrochlorideTAKEDA PHARMS USANDA022426
OXYTROL FOR WOMENoxybutyninABBVIENDA202211
SUCLEARmagnesium sulfate, polyethylene glycol 3350, potassium chloride, potassium sulfate, sodium bicarbonate, sodium chloride, sodium sulfateBRAINTREE LABSNDA203595
ZECUITYsumatriptan succinateTEVA BRANDED PHARMNDA202278
UCERISbudesonideSALIXNDA203634
VAZALOREaspirinPLX PHARMANDA203697
SKYLAlevonorgestrelBAYER HLTHCARENDA203159