All FDA drug approvals

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FDA drug approvals — brands starting with O

220 FDA applications with an approved original submission carry a brand starting with O, the earliest approved in 1953 and the most recent in 2026. FDA marks 90 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.

BrandIngredientApprovedSponsorApplication
OBREDONguaifenesin, hydrocodone bitartrateSOVEREIGN PHARMSNDA205474
OCALIVAobeticholic acidINTERCEPTNDA207999
OCLpolyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride, sodium sulfateHOSPIRANDA019284
OCREVUSocrelizumabGENENTECH INCBLA761053
OCREVUS ZUNOVOocrelizumab and hyaluronidase-ocsqGENENTECH INCBLA761371
OCTREOSCANindium in-111 pentetreotide kitCURIUMNDA020314
OCUCLEARoxymetazoline hydrochlorideBAYER HEALTHCARE LLCNDA018471
OCUFENflurbiprofen sodiumALLERGANNDA019404
OCUFLOXofloxacinALLERGANNDA019921
OCUPRESScarteolol hydrochlorideNOVARTISNDA019972
OCUSERT PILO-20pilocarpineEPIC PHARMA LLCNDA017431
OCUSERT PILO-40pilocarpineEPIC PHARMA LLCNDA017548
ODEFSEYemtricitabine, rilpivirine hydrochloride, tenofovir alafenamide fumarateGILEAD SCIENCES INCNDA208351
ODOMZOsonidegib phosphateSUN PHARMNDA205266
OFEVnintedanib esylateBOEHRINGER INGELHEIMNDA205832
OFIRMEVacetaminophenMALLINCKRODT HOSPNDA022450
OFORTAfludarabine phosphateSANOFI AVENTIS USNDA022273
OGIVRItrastuzumab-dkstMYLAN GMBHBLA761074
OGSIVEOnirogacestat hydrobromideSPRINGWORKSNDA217677
OHTUVAYREensifentrineMSDNDA217389
OJEMDAtovorafenibDAY ONE BIOPHARMSNDA217700
OJEMDAtovorafenibDAY ONE BIOPHARMSNDA218033
OJJAARAmomelotinib dihydrochlorideGLAXOSMITHKLINENDA216873
OLEPTROtrazodone hydrochlorideANGELINI PHARMANDA022411
OLINVYKoliceridineTREVENANDA210730
OLPRUVAsodium phenylbutyrateACERNDA214860
OLUMIANTbaricitinibELI LILLY AND CONDA207924
OLUXclobetasol propionateQUAGENNDA021142
OLUX Eclobetasol propionateQUAGENNDA022013
OLYSIOsimeprevir sodiumJANSSEN PRODSNDA205123
OMACORomega-3acid ethyl estersRELIANT PHARMSNDA021853
OMECLAMOX-PAKamoxicillin, clarithromycin, omeprazoleCUMBERLANDNDA050824
OMEGAVENfish oil triglyceridesFRESENIUS KABI USANDA210589
OMEPRAZOLEomeprazoleDEXCEL PHARMANDA022032
OMEPRAZOLEomeprazoleDEXCELNDA209400
OMIDRIAketorolac tromethamine, phenylephrine hydrochlorideRAYNER SURGICALNDA205388
OMLONTIomidenepag isopropylOCUVEX THERAPNDA215092
OMLYCLOomalizumab-igecCELLTRION INCBLA761399
OMNARISciclesonideAZURITYNDA022004
OMNARISciclesonideNYCOMED US INCNDA022124
OMNICEFcefdinirABBVIENDA050739
OMNICEFcefdinirABBVIENDA050749
OMNIPAQUE 140iohexolGE HEALTHCARENDA018956
OMNIPAQUE 350iohexolGE HEALTHCARENDA020608
OMNIPREDprednisolone acetateSANDOZNDA017469
OMNISCANgadodiamideGE HEALTHCARENDA020123
OMNISCANgadodiamideGE HEALTHCARENDA022066
OMNITROPEsomatropinSANDOZBLA021426
OMONTYSpeginesatide acetateTAKEDA PHARMS USANDA202799
OMTRYGomega-3-acid ethyl esters type aOSMOTICA PHARM USNDA204977
OMVOHmirikizumab-mrkzELI LILLY AND COBLA761279
ONAPGOapomorphine hydrochlorideMDD USNDA214056
ONCASPARpegaspargaseSIGMA TAUBLA103411
ONCOVINvincristine sulfateLILLYNDA014103
ONFIclobazamLUNDBECK PHARMS LLCNDA202067
ONFIclobazamLUNDBECK PHARMS LLCNDA203993
ONGENTYSopicaponeAMNEALNDA212489
ONGLYZAsaxagliptin hydrochlorideASTRAZENECA ABNDA022350
ONIVYDEirinotecan hydrochlorideIPSENNDA207793
ONMELitraconazoleSEBELA IRELAND LTDNDA022484
ONPATTROpatisiran sodiumALNYLAM PHARMS INCNDA210922
ONSOLISfentanyl citrateADALVONDA022266
ONTAKdenileukin diftitoxEISAI INCBLA103767
ONTRALFYtizanidine hydrochlorideFIDELITY BIOPHARMANDA216190
ONTRUZANTtrastuzumab-dttbSAMSUNG BIOEPIS CO LTDBLA761100
ONUREGazacitidineBRISTOLNDA214120
ONYDA XRclonidine hydrochlorideTRIS PHARMA INCNDA217645
ONZETRA XSAILsumatriptan succinateAZURITYNDA206099
OPANAoxymorphone hydrochlorideENDO PHARMSNDA011707
OPANAoxymorphone hydrochlorideENDO PHARMSNDA021611
OPANA ERoxymorphone hydrochlorideENDO OPERATIONSNDA021610
OPANA ERoxymorphone hydrochlorideENDO PHARMSNDA201655
OPCON-Anaphazoline hydrochloride, pheniramine maleateBAUSCH AND LOMBNDA020065
OPDIVOnivolumabBRISTOL MYERS SQUIBBBLA125527
OPDIVOnivolumabBRISTOL MYERS SQUIBBBLA125554
OPDIVO QVANTIGnivolumab, hyaluronidase-nvhyBRISTOL-MYERS SQUIBBBLA761381
OPDIVO QVANTIGnivolumab, hyaluronidase-nvhyBRISTOL-MYERS SQUIBBBLA761429
OPDUALAGnivolumab, relatlimab-rmbwBRISTOL MYERS SQUIBBBLA761234
OPFOLDAmiglustatAMICUS THERAP USNDA215211
OPHTHAINEproparacaine hydrochlorideAPOTHECONNDA008883
OPHTHETICproparacaine hydrochlorideALLERGANNDA012583
OPHTHOCORTchloramphenicol, hydrocortisone acetate, polymyxin b sulfatePARKEDALENDA050201
OPILLnorgestrelLABORATOIRE HRANDA017031
OPIPZAaripiprazoleXIAMEN LP PHARM CONDA216655
OPSUMITmacitentanACTELIONNDA204410
OPSYNVImacitentan, tadalafilACTELIONNDA218490
OPTICROMcromolyn sodiumALLERGANNDA018155
OPTIMARKgadoversetamideLIEBEL-FLARSHEIMNDA020937
OPTIMARKgadoversetamideLIEBEL-FLARSHEIMNDA020975
OPTIMARK IN PLASTIC CONTAINERgadoversetamideLIEBEL-FLARSHEIMNDA020976
OPTIMINEazatadine maleateSCHERINGNDA017601
OPTIPRANOLOLmetipranolol hydrochlorideBAUSCH AND LOMBNDA019907
OPTIRAY 300ioversolLIEBEL-FLARSHEIMNDA020923
OPTIRAY 350ioversolLIEBEL-FLARSHEIMNDA019710
OPTISONalbumin humanGE HEALTHCARENDA020899
OPTIVARazelastine hydrochlorideRISINGNDA021127
OPUVIZaflibercept-yszySAMSUNG BIOEPIS CO LTDBLA761350
OPVEEnalmefene hydrochlorideINDIVIORNDA217470
OPZELURAruxolitinib phosphateINCYTE CORPNDA215309
ORABLOCarticaine hydrochloride, epinephrine bitartratePIERRELNDA022466
ORACEAdoxycyclineGALDERMA LABS LPNDA050805
ORAGRAFIN CALCIUMipodate calciumBRACCONDA012968
ORAGRAFIN SODIUMipodate sodiumBRACCONDA012967
ORALTAGiohexolINTERPHARMA PRAHA ASNDA205383
ORAMORPH SRmorphine sulfateXANODYNE PHARMS INCNDA019977
ORAPpimozideTEVANDA017473
ORAPRED ODTprednisolone sodium phosphateADVANZ PHARMANDA021959
ORAQIXlidocaine, prilocaineDENTSPLY PHARMNDA021451
ORAVERSEphentolamine mesylateSEPTODONT HOLDINGNDA022159
ORAVIGmiconazoleGALT PHARMSNDA022404
ORBACTIVoritavancin diphosphateMELINTA THERAPNDA206334
ORENCIAabataceptBRISTOL MYERS SQUIBBBLA125118
ORENITRAMtreprostinil diolamineUNITED THERAPNDA203496
ORETIChydrochlorothiazideABBVIENDA011971
ORETICYL 50deserpidine, hydrochlorothiazideABBVIENDA012148
ORFADINnitisinoneSWEDISH ORPHANNDA021232
ORFADINnitisinoneSWEDISH ORPHANNDA206356
ORGARANdanaparoid sodiumASPEN GLOBAL INCNDA020430
ORGOVYXrelugolixSUMITOMO PHARMA AMNDA214621
ORIAHNN (COPACKAGED)elagolix sodium,estradiol,norethindrone acetate, elagolix sodiumABBVIENDA213388
ORILISSAelagolix sodiumABBVIENDA210450
ORINASEtolbutamidePHARMACIA AND UPJOHNNDA010670
ORINASE DIAGNOSTICtolbutamide sodiumPHARMACIA AND UPJOHNNDA012095
ORKAMBIivacaftor, lumacaftorVERTEX PHARMS INCNDA206038
ORKAMBIivacaftor, lumacaftorVERTEX PHARMS INCNDA211358
ORLAAMlevomethadyl acetate hydrochlorideROXANENDA020315
ORLADEYOberotralstat dihydrochlorideBIOCRYSTNDA214094
ORLADEYOberotralstat dihydrochlorideBIOCRYSTNDA219776
ORLYNVAHprobenecid, sulopenem etzadroxilITERUM THERAPNDA213972
ORNIDYLeflornithine hydrochlorideSANOFI AVENTIS USNDA019879
ORSERDUelacestrant hydrochlorideSTEMLINE THERAPNDA217639
ORTHO CYCLEN-28ethinyl estradiol, norgestimateJANSSEN PHARMSNDA019653
ORTHO EVRAethinyl estradiol, norelgestrominJANSSEN PHARMSNDA021180
ORTHO TRI-CYCLENethinyl estradiol, norgestimateJANSSEN PHARMSNDA019697
ORTHO TRI-CYCLEN 28ethinyl estradiol, norgestimateORTHO MCNEIL PHARMNDA021690
ORTHO TRI-CYCLEN LOethinyl estradiol, norgestimateJANSSEN PHARMSNDA021241
ORTHO-CEPTdesogestrel, ethinyl estradiolJANSSEN PHARMSNDA020301
ORTHO-NOVUM 1/35-21ethinyl estradiol, norethindroneORTHO MCNEIL PHARMNDA017489
ORTHO-NOVUM 1/35-28ethinyl estradiol, norethindroneJANSSEN PHARMSNDA017919
ORTHO-NOVUM 1/50 21mestranol, norethindroneORTHO MCNEIL PHARMNDA012728
ORTHO-NOVUM 1/50 28mestranol, norethindroneORTHO MCNEIL JANSSENNDA016709
ORTHO-NOVUM 10/11-28ethinyl estradiol, norethindroneORTHO MCNEIL JANSSENNDA018354
ORTHO-NOVUM 7/14-21ethinyl estradiol, norethindroneORTHO MCNEIL PHARMNDA019004
ORTHO-NOVUM 7/7/7-28ethinyl estradiol, norethindroneJANSSEN PHARMSNDA018985
ORTIKOSbudesonideSUN PHARM INDS INCNDA211929
ORUDISketoprofenWYETH AYERSTNDA018754
ORUDIS KTketoprofenWYETH CONSNDA020429
ORUVAILketoprofenWYETH PHARMS INCNDA019816
ORZEYFULoveporextonTAKEDA PHARMS USANDA220860
OSENIalogliptin benzoate, pioglitazone hydrochlorideTAKEDA PHARMS USANDA022426
OSENVELTdenosumab-bmwoCELLTRION INCBLA761404
OSMITROL 20% IN WATER IN PLASTIC CONTAINERmannitolBAXTER HLTHCARENDA013684
OSMOLEX ERamantadine hydrochlorideSUPERNUS PHARMSNDA209410
OSMOPREPsodium phosphate, dibasic, anhydrous, sodium phosphate, monobasic, monohydrateSALIX PHARMSNDA021892
OSPHENAospemifeneDUCHESNAYNDA203505
OSTEOLITEtechnetium tc-99m medronate kitSUN PHARM INDS INCNDA017972
OSTEOSCANtechnetium tc-99m etidronate kitMALLINCKRODTNDA017454
OSVYRTIdenosumab-desuACCORD BIOPHARMA INC.BLA761424
OTEZLAapremilastAMGEN INCNDA205437
OTEZLAapremilastCELGENE CORPNDA206088
OTEZLAapremilastAMGEN INCNDA210745
OTIPRIOciprofloxacinALK ABELLONDA207986
OTOVELciprofloxacin hydrochloride, fluocinolone acetonideLAB SALVATNDA208251
OTREXUPmethotrexateCOSETTENDA204824
OTULFIustekinumab-aauzFRESENIUS KABI USABLA761379
OVCON-35ethinyl estradiol, norethindroneWARNER CHILCOTT LLCNDA017716
OVCON-35ethinyl estradiol, norethindroneWARNER CHILCOTTNDA018127
OVCON-50ethinyl estradiol, norethindroneWARNER CHILCOTT LLCNDA017576
OVCON-50ethinyl estradiol, norethindroneWARNER CHILCOTTNDA018128
OVIDEmalathionTARONDA018613
OVIDRELchoriogonadotropin alfaEMD SERONOBLA021149
OVRALethinyl estradiol, norgestrelWYETH PHARMSNDA016672
OVRAL-28ethinyl estradiol, norgestrelWYETH PHARMSNDA016806
OVULEN-21ethynodiol diacetate, mestranolGD SEARLE LLCNDA016029
OVULEN-28ethynodiol diacetate, mestranolGD SEARLE LLCNDA016705
OXALIPLATINoxaliplatinTEVA PHARMSNDA022160
OXAYDOoxycodone hydrochlorideZYLANDA202080
OXBRYTAvoxelotorGLOBAL BLOOD THERAPSNDA213137
OXBRYTAvoxelotorGLOBAL BLOOD THERAPSNDA216157
OXERVATEcenegermin-bkbjDOMPE FARMACEUTICIBLA761094
OXILAN-350ioxilanGUERBETNDA020316
OXISTAToxiconazole nitrateFOUGERANDA019828
OXISTAToxiconazole nitrateANI PHARMSNDA020209
OXLUMOlumasiran sodiumALNYLAM PHARMS INCNDA214103
OXSORALEN-ULTRAmethoxsalenBAUSCHNDA019600
OXTELLAR XRoxcarbazepineSUPERNUS PHARMSNDA202810
OXYCODONE HYDROCHLORIDEoxycodone hydrochlorideGENUS LIFESCIENCESNDA200534
OXYCODONE HYDROCHLORIDEoxycodone hydrochlorideGENUS LIFESCIENCESNDA200535
OXYCODONE HYDROCHLORIDEoxycodone hydrochlorideVISTAPHARM LLCNDA201194
OXYCONTINoxycodone hydrochlorideKNOA PHARMANDA022272
OXYGEN, USPoxygenAIR LIQUID INDUSTRIAL US LPNDA205712
OXYGEN, USPoxygenAIR LIQUID INDUSTRIAL US LPNDA205713
OXYGEN, USPoxygenAIR LIQUIDE LARGE INDUSTRIES US LPNDA205737
OXYGEN, USPoxygenLINDE NORTH AMERICA INCNDA205767
OXYGEN, USPoxygenLINDE NORTH AMERICA INCNDA205817
OXYGEN, USPoxygenLINDE GAS PUERTO RICO INCNDA205818
OXYGEN, USPoxygenNORCO INCNDA205820
OXYGEN, USPoxygenAIR LIQUIDE AMERICA LPNDA205827
OXYGEN, USPoxygenAIRGAS MERCHANTS GASES LLCNDA205840
OXYGEN, USPoxygenPRAXAIR INCNDA205849
OXYGEN, USPoxygenASPEN AIRNDA205862
OXYGEN, USPoxygenAIR PRODUCTS AND CHEMICALS INCNDA205865
OXYGEN, USPoxygenMATHESON TRI-GAS INCNDA205889
OXYGEN, USPoxygenPRAXAIR CANADA INCNDA205986
OXYGEN, USPoxygenAIRGAS USA LLCNDA206023
OXYGEN, USPoxygenPRAXAIR MEXICONDA210844
OXYGEN, USPoxygenCRISTAL ASU LLCNDA211739
OXYGEN, USPoxygenUNIVERSAL INDUSTRIAL GASES, INCNDA212314
OXYGEN, USPoxygenAIR LIQUIDE CANADA INCNDA214857
OXYGEN, USPoxygenABSOLUTE AIR, LLCNDA217500
OXYTOCINoxytocinHIKMANDA018243
OXYTOCINoxytocinFRESENIUS KABI USANDA018248
OXYTOCIN 10 USP UNITS IN DEXTROSE 5%oxytocinABBOTTNDA019185
OXYTROLoxybutyninALLERGANNDA021351
OXYTROL FOR WOMENoxybutyninABBVIENDA202211
OZEMPICsemaglutideNOVONDA209637
OZEMPICsemaglutideNOVONDA213051
OZILTUSdenosumab-mobzAMNEAL PHARMS LLCBLA761457
OZOBAX DSbaclofenMETACEL PHARMS LLCNDA208193
OZURDEXdexamethasoneABBVIENDA022315