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.
| Brand | Ingredient | Approved | Sponsor | Application |
|---|---|---|---|---|
| OBREDON | guaifenesin, hydrocodone bitartrate | SOVEREIGN PHARMS | NDA205474 | |
| OCALIVA | obeticholic acid | INTERCEPT | NDA207999 | |
| OCL | polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride, sodium sulfate | HOSPIRA | NDA019284 | |
| OCREVUS | ocrelizumab | GENENTECH INC | BLA761053 | |
| OCREVUS ZUNOVO | ocrelizumab and hyaluronidase-ocsq | GENENTECH INC | BLA761371 | |
| OCTREOSCAN | indium in-111 pentetreotide kit | CURIUM | NDA020314 | |
| OCUCLEAR | oxymetazoline hydrochloride | BAYER HEALTHCARE LLC | NDA018471 | |
| OCUFEN | flurbiprofen sodium | ALLERGAN | NDA019404 | |
| OCUFLOX | ofloxacin | ALLERGAN | NDA019921 | |
| OCUPRESS | carteolol hydrochloride | NOVARTIS | NDA019972 | |
| OCUSERT PILO-20 | pilocarpine | EPIC PHARMA LLC | NDA017431 | |
| OCUSERT PILO-40 | pilocarpine | EPIC PHARMA LLC | NDA017548 | |
| ODEFSEY | emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide fumarate | GILEAD SCIENCES INC | NDA208351 | |
| ODOMZO | sonidegib phosphate | SUN PHARM | NDA205266 | |
| OFEV | nintedanib esylate | BOEHRINGER INGELHEIM | NDA205832 | |
| OFIRMEV | acetaminophen | MALLINCKRODT HOSP | NDA022450 | |
| OFORTA | fludarabine phosphate | SANOFI AVENTIS US | NDA022273 | |
| OGIVRI | trastuzumab-dkst | MYLAN GMBH | BLA761074 | |
| OGSIVEO | nirogacestat hydrobromide | SPRINGWORKS | NDA217677 | |
| OHTUVAYRE | ensifentrine | MSD | NDA217389 | |
| OJEMDA | tovorafenib | DAY ONE BIOPHARMS | NDA217700 | |
| OJEMDA | tovorafenib | DAY ONE BIOPHARMS | NDA218033 | |
| OJJAARA | momelotinib dihydrochloride | GLAXOSMITHKLINE | NDA216873 | |
| OLEPTRO | trazodone hydrochloride | ANGELINI PHARMA | NDA022411 | |
| OLINVYK | oliceridine | TREVENA | NDA210730 | |
| OLPRUVA | sodium phenylbutyrate | ACER | NDA214860 | |
| OLUMIANT | baricitinib | ELI LILLY AND CO | NDA207924 | |
| OLUX | clobetasol propionate | QUAGEN | NDA021142 | |
| OLUX E | clobetasol propionate | QUAGEN | NDA022013 | |
| OLYSIO | simeprevir sodium | JANSSEN PRODS | NDA205123 | |
| OMACOR | omega-3acid ethyl esters | RELIANT PHARMS | NDA021853 | |
| OMECLAMOX-PAK | amoxicillin, clarithromycin, omeprazole | CUMBERLAND | NDA050824 | |
| OMEGAVEN | fish oil triglycerides | FRESENIUS KABI USA | NDA210589 | |
| OMEPRAZOLE | omeprazole | DEXCEL PHARMA | NDA022032 | |
| OMEPRAZOLE | omeprazole | DEXCEL | NDA209400 | |
| OMIDRIA | ketorolac tromethamine, phenylephrine hydrochloride | RAYNER SURGICAL | NDA205388 | |
| OMLONTI | omidenepag isopropyl | OCUVEX THERAP | NDA215092 | |
| OMLYCLO | omalizumab-igec | CELLTRION INC | BLA761399 | |
| OMNARIS | ciclesonide | AZURITY | NDA022004 | |
| OMNARIS | ciclesonide | NYCOMED US INC | NDA022124 | |
| OMNICEF | cefdinir | ABBVIE | NDA050739 | |
| OMNICEF | cefdinir | ABBVIE | NDA050749 | |
| OMNIPAQUE 140 | iohexol | GE HEALTHCARE | NDA018956 | |
| OMNIPAQUE 350 | iohexol | GE HEALTHCARE | NDA020608 | |
| OMNIPRED | prednisolone acetate | SANDOZ | NDA017469 | |
| OMNISCAN | gadodiamide | GE HEALTHCARE | NDA020123 | |
| OMNISCAN | gadodiamide | GE HEALTHCARE | NDA022066 | |
| OMNITROPE | somatropin | SANDOZ | BLA021426 | |
| OMONTYS | peginesatide acetate | TAKEDA PHARMS USA | NDA202799 | |
| OMTRYG | omega-3-acid ethyl esters type a | OSMOTICA PHARM US | NDA204977 | |
| OMVOH | mirikizumab-mrkz | ELI LILLY AND CO | BLA761279 | |
| ONAPGO | apomorphine hydrochloride | MDD US | NDA214056 | |
| ONCASPAR | pegaspargase | SIGMA TAU | BLA103411 | |
| ONCOVIN | vincristine sulfate | LILLY | NDA014103 | |
| ONFI | clobazam | LUNDBECK PHARMS LLC | NDA202067 | |
| ONFI | clobazam | LUNDBECK PHARMS LLC | NDA203993 | |
| ONGENTYS | opicapone | AMNEAL | NDA212489 | |
| ONGLYZA | saxagliptin hydrochloride | ASTRAZENECA AB | NDA022350 | |
| ONIVYDE | irinotecan hydrochloride | IPSEN | NDA207793 | |
| ONMEL | itraconazole | SEBELA IRELAND LTD | NDA022484 | |
| ONPATTRO | patisiran sodium | ALNYLAM PHARMS INC | NDA210922 | |
| ONSOLIS | fentanyl citrate | ADALVO | NDA022266 | |
| ONTAK | denileukin diftitox | EISAI INC | BLA103767 | |
| ONTRALFY | tizanidine hydrochloride | FIDELITY BIOPHARMA | NDA216190 | |
| ONTRUZANT | trastuzumab-dttb | SAMSUNG BIOEPIS CO LTD | BLA761100 | |
| ONUREG | azacitidine | BRISTOL | NDA214120 | |
| ONYDA XR | clonidine hydrochloride | TRIS PHARMA INC | NDA217645 | |
| ONZETRA XSAIL | sumatriptan succinate | AZURITY | NDA206099 | |
| OPANA | oxymorphone hydrochloride | ENDO PHARMS | NDA011707 | |
| OPANA | oxymorphone hydrochloride | ENDO PHARMS | NDA021611 | |
| OPANA ER | oxymorphone hydrochloride | ENDO OPERATIONS | NDA021610 | |
| OPANA ER | oxymorphone hydrochloride | ENDO PHARMS | NDA201655 | |
| OPCON-A | naphazoline hydrochloride, pheniramine maleate | BAUSCH AND LOMB | NDA020065 | |
| OPDIVO | nivolumab | BRISTOL MYERS SQUIBB | BLA125527 | |
| OPDIVO | nivolumab | BRISTOL MYERS SQUIBB | BLA125554 | |
| OPDIVO QVANTIG | nivolumab, hyaluronidase-nvhy | BRISTOL-MYERS SQUIBB | BLA761381 | |
| OPDIVO QVANTIG | nivolumab, hyaluronidase-nvhy | BRISTOL-MYERS SQUIBB | BLA761429 | |
| OPDUALAG | nivolumab, relatlimab-rmbw | BRISTOL MYERS SQUIBB | BLA761234 | |
| OPFOLDA | miglustat | AMICUS THERAP US | NDA215211 | |
| OPHTHAINE | proparacaine hydrochloride | APOTHECON | NDA008883 | |
| OPHTHETIC | proparacaine hydrochloride | ALLERGAN | NDA012583 | |
| OPHTHOCORT | chloramphenicol, hydrocortisone acetate, polymyxin b sulfate | PARKEDALE | NDA050201 | |
| OPILL | norgestrel | LABORATOIRE HRA | NDA017031 | |
| OPIPZA | aripiprazole | XIAMEN LP PHARM CO | NDA216655 | |
| OPSUMIT | macitentan | ACTELION | NDA204410 | |
| OPSYNVI | macitentan, tadalafil | ACTELION | NDA218490 | |
| OPTICROM | cromolyn sodium | ALLERGAN | NDA018155 | |
| OPTIMARK | gadoversetamide | LIEBEL-FLARSHEIM | NDA020937 | |
| OPTIMARK | gadoversetamide | LIEBEL-FLARSHEIM | NDA020975 | |
| OPTIMARK IN PLASTIC CONTAINER | gadoversetamide | LIEBEL-FLARSHEIM | NDA020976 | |
| OPTIMINE | azatadine maleate | SCHERING | NDA017601 | |
| OPTIPRANOLOL | metipranolol hydrochloride | BAUSCH AND LOMB | NDA019907 | |
| OPTIRAY 300 | ioversol | LIEBEL-FLARSHEIM | NDA020923 | |
| OPTIRAY 350 | ioversol | LIEBEL-FLARSHEIM | NDA019710 | |
| OPTISON | albumin human | GE HEALTHCARE | NDA020899 | |
| OPTIVAR | azelastine hydrochloride | RISING | NDA021127 | |
| OPUVIZ | aflibercept-yszy | SAMSUNG BIOEPIS CO LTD | BLA761350 | |
| OPVEE | nalmefene hydrochloride | INDIVIOR | NDA217470 | |
| OPZELURA | ruxolitinib phosphate | INCYTE CORP | NDA215309 | |
| ORABLOC | articaine hydrochloride, epinephrine bitartrate | PIERREL | NDA022466 | |
| ORACEA | doxycycline | GALDERMA LABS LP | NDA050805 | |
| ORAGRAFIN CALCIUM | ipodate calcium | BRACCO | NDA012968 | |
| ORAGRAFIN SODIUM | ipodate sodium | BRACCO | NDA012967 | |
| ORALTAG | iohexol | INTERPHARMA PRAHA AS | NDA205383 | |
| ORAMORPH SR | morphine sulfate | XANODYNE PHARMS INC | NDA019977 | |
| ORAP | pimozide | TEVA | NDA017473 | |
| ORAPRED ODT | prednisolone sodium phosphate | ADVANZ PHARMA | NDA021959 | |
| ORAQIX | lidocaine, prilocaine | DENTSPLY PHARM | NDA021451 | |
| ORAVERSE | phentolamine mesylate | SEPTODONT HOLDING | NDA022159 | |
| ORAVIG | miconazole | GALT PHARMS | NDA022404 | |
| ORBACTIV | oritavancin diphosphate | MELINTA THERAP | NDA206334 | |
| ORENCIA | abatacept | BRISTOL MYERS SQUIBB | BLA125118 | |
| ORENITRAM | treprostinil diolamine | UNITED THERAP | NDA203496 | |
| ORETIC | hydrochlorothiazide | ABBVIE | NDA011971 | |
| ORETICYL 50 | deserpidine, hydrochlorothiazide | ABBVIE | NDA012148 | |
| ORFADIN | nitisinone | SWEDISH ORPHAN | NDA021232 | |
| ORFADIN | nitisinone | SWEDISH ORPHAN | NDA206356 | |
| ORGARAN | danaparoid sodium | ASPEN GLOBAL INC | NDA020430 | |
| ORGOVYX | relugolix | SUMITOMO PHARMA AM | NDA214621 | |
| ORIAHNN (COPACKAGED) | elagolix sodium,estradiol,norethindrone acetate, elagolix sodium | ABBVIE | NDA213388 | |
| ORILISSA | elagolix sodium | ABBVIE | NDA210450 | |
| ORINASE | tolbutamide | PHARMACIA AND UPJOHN | NDA010670 | |
| ORINASE DIAGNOSTIC | tolbutamide sodium | PHARMACIA AND UPJOHN | NDA012095 | |
| ORKAMBI | ivacaftor, lumacaftor | VERTEX PHARMS INC | NDA206038 | |
| ORKAMBI | ivacaftor, lumacaftor | VERTEX PHARMS INC | NDA211358 | |
| ORLAAM | levomethadyl acetate hydrochloride | ROXANE | NDA020315 | |
| ORLADEYO | berotralstat dihydrochloride | BIOCRYST | NDA214094 | |
| ORLADEYO | berotralstat dihydrochloride | BIOCRYST | NDA219776 | |
| ORLYNVAH | probenecid, sulopenem etzadroxil | ITERUM THERAP | NDA213972 | |
| ORNIDYL | eflornithine hydrochloride | SANOFI AVENTIS US | NDA019879 | |
| ORSERDU | elacestrant hydrochloride | STEMLINE THERAP | NDA217639 | |
| ORTHO CYCLEN-28 | ethinyl estradiol, norgestimate | JANSSEN PHARMS | NDA019653 | |
| ORTHO EVRA | ethinyl estradiol, norelgestromin | JANSSEN PHARMS | NDA021180 | |
| ORTHO TRI-CYCLEN | ethinyl estradiol, norgestimate | JANSSEN PHARMS | NDA019697 | |
| ORTHO TRI-CYCLEN 28 | ethinyl estradiol, norgestimate | ORTHO MCNEIL PHARM | NDA021690 | |
| ORTHO TRI-CYCLEN LO | ethinyl estradiol, norgestimate | JANSSEN PHARMS | NDA021241 | |
| ORTHO-CEPT | desogestrel, ethinyl estradiol | JANSSEN PHARMS | NDA020301 | |
| ORTHO-NOVUM 1/35-21 | ethinyl estradiol, norethindrone | ORTHO MCNEIL PHARM | NDA017489 | |
| ORTHO-NOVUM 1/35-28 | ethinyl estradiol, norethindrone | JANSSEN PHARMS | NDA017919 | |
| ORTHO-NOVUM 1/50 21 | mestranol, norethindrone | ORTHO MCNEIL PHARM | NDA012728 | |
| ORTHO-NOVUM 1/50 28 | mestranol, norethindrone | ORTHO MCNEIL JANSSEN | NDA016709 | |
| ORTHO-NOVUM 10/11-28 | ethinyl estradiol, norethindrone | ORTHO MCNEIL JANSSEN | NDA018354 | |
| ORTHO-NOVUM 7/14-21 | ethinyl estradiol, norethindrone | ORTHO MCNEIL PHARM | NDA019004 | |
| ORTHO-NOVUM 7/7/7-28 | ethinyl estradiol, norethindrone | JANSSEN PHARMS | NDA018985 | |
| ORTIKOS | budesonide | SUN PHARM INDS INC | NDA211929 | |
| ORUDIS | ketoprofen | WYETH AYERST | NDA018754 | |
| ORUDIS KT | ketoprofen | WYETH CONS | NDA020429 | |
| ORUVAIL | ketoprofen | WYETH PHARMS INC | NDA019816 | |
| ORZEYFUL | oveporexton | TAKEDA PHARMS USA | NDA220860 | |
| OSENI | alogliptin benzoate, pioglitazone hydrochloride | TAKEDA PHARMS USA | NDA022426 | |
| OSENVELT | denosumab-bmwo | CELLTRION INC | BLA761404 | |
| OSMITROL 20% IN WATER IN PLASTIC CONTAINER | mannitol | BAXTER HLTHCARE | NDA013684 | |
| OSMOLEX ER | amantadine hydrochloride | SUPERNUS PHARMS | NDA209410 | |
| OSMOPREP | sodium phosphate, dibasic, anhydrous, sodium phosphate, monobasic, monohydrate | SALIX PHARMS | NDA021892 | |
| OSPHENA | ospemifene | DUCHESNAY | NDA203505 | |
| OSTEOLITE | technetium tc-99m medronate kit | SUN PHARM INDS INC | NDA017972 | |
| OSTEOSCAN | technetium tc-99m etidronate kit | MALLINCKRODT | NDA017454 | |
| OSVYRTI | denosumab-desu | ACCORD BIOPHARMA INC. | BLA761424 | |
| OTEZLA | apremilast | AMGEN INC | NDA205437 | |
| OTEZLA | apremilast | CELGENE CORP | NDA206088 | |
| OTEZLA | apremilast | AMGEN INC | NDA210745 | |
| OTIPRIO | ciprofloxacin | ALK ABELLO | NDA207986 | |
| OTOVEL | ciprofloxacin hydrochloride, fluocinolone acetonide | LAB SALVAT | NDA208251 | |
| OTREXUP | methotrexate | COSETTE | NDA204824 | |
| OTULFI | ustekinumab-aauz | FRESENIUS KABI USA | BLA761379 | |
| OVCON-35 | ethinyl estradiol, norethindrone | WARNER CHILCOTT LLC | NDA017716 | |
| OVCON-35 | ethinyl estradiol, norethindrone | WARNER CHILCOTT | NDA018127 | |
| OVCON-50 | ethinyl estradiol, norethindrone | WARNER CHILCOTT LLC | NDA017576 | |
| OVCON-50 | ethinyl estradiol, norethindrone | WARNER CHILCOTT | NDA018128 | |
| OVIDE | malathion | TARO | NDA018613 | |
| OVIDREL | choriogonadotropin alfa | EMD SERONO | BLA021149 | |
| OVRAL | ethinyl estradiol, norgestrel | WYETH PHARMS | NDA016672 | |
| OVRAL-28 | ethinyl estradiol, norgestrel | WYETH PHARMS | NDA016806 | |
| OVULEN-21 | ethynodiol diacetate, mestranol | GD SEARLE LLC | NDA016029 | |
| OVULEN-28 | ethynodiol diacetate, mestranol | GD SEARLE LLC | NDA016705 | |
| OXALIPLATIN | oxaliplatin | TEVA PHARMS | NDA022160 | |
| OXAYDO | oxycodone hydrochloride | ZYLA | NDA202080 | |
| OXBRYTA | voxelotor | GLOBAL BLOOD THERAPS | NDA213137 | |
| OXBRYTA | voxelotor | GLOBAL BLOOD THERAPS | NDA216157 | |
| OXERVATE | cenegermin-bkbj | DOMPE FARMACEUTICI | BLA761094 | |
| OXILAN-350 | ioxilan | GUERBET | NDA020316 | |
| OXISTAT | oxiconazole nitrate | FOUGERA | NDA019828 | |
| OXISTAT | oxiconazole nitrate | ANI PHARMS | NDA020209 | |
| OXLUMO | lumasiran sodium | ALNYLAM PHARMS INC | NDA214103 | |
| OXSORALEN-ULTRA | methoxsalen | BAUSCH | NDA019600 | |
| OXTELLAR XR | oxcarbazepine | SUPERNUS PHARMS | NDA202810 | |
| OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | GENUS LIFESCIENCES | NDA200534 | |
| OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | GENUS LIFESCIENCES | NDA200535 | |
| OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | VISTAPHARM LLC | NDA201194 | |
| OXYCONTIN | oxycodone hydrochloride | KNOA PHARMA | NDA022272 | |
| OXYGEN, USP | oxygen | AIR LIQUID INDUSTRIAL US LP | NDA205712 | |
| OXYGEN, USP | oxygen | AIR LIQUID INDUSTRIAL US LP | NDA205713 | |
| OXYGEN, USP | oxygen | AIR LIQUIDE LARGE INDUSTRIES US LP | NDA205737 | |
| OXYGEN, USP | oxygen | LINDE NORTH AMERICA INC | NDA205767 | |
| OXYGEN, USP | oxygen | LINDE NORTH AMERICA INC | NDA205817 | |
| OXYGEN, USP | oxygen | LINDE GAS PUERTO RICO INC | NDA205818 | |
| OXYGEN, USP | oxygen | NORCO INC | NDA205820 | |
| OXYGEN, USP | oxygen | AIR LIQUIDE AMERICA LP | NDA205827 | |
| OXYGEN, USP | oxygen | AIRGAS MERCHANTS GASES LLC | NDA205840 | |
| OXYGEN, USP | oxygen | PRAXAIR INC | NDA205849 | |
| OXYGEN, USP | oxygen | ASPEN AIR | NDA205862 | |
| OXYGEN, USP | oxygen | AIR PRODUCTS AND CHEMICALS INC | NDA205865 | |
| OXYGEN, USP | oxygen | MATHESON TRI-GAS INC | NDA205889 | |
| OXYGEN, USP | oxygen | PRAXAIR CANADA INC | NDA205986 | |
| OXYGEN, USP | oxygen | AIRGAS USA LLC | NDA206023 | |
| OXYGEN, USP | oxygen | PRAXAIR MEXICO | NDA210844 | |
| OXYGEN, USP | oxygen | CRISTAL ASU LLC | NDA211739 | |
| OXYGEN, USP | oxygen | UNIVERSAL INDUSTRIAL GASES, INC | NDA212314 | |
| OXYGEN, USP | oxygen | AIR LIQUIDE CANADA INC | NDA214857 | |
| OXYGEN, USP | oxygen | ABSOLUTE AIR, LLC | NDA217500 | |
| OXYTOCIN | oxytocin | HIKMA | NDA018243 | |
| OXYTOCIN | oxytocin | FRESENIUS KABI USA | NDA018248 | |
| OXYTOCIN 10 USP UNITS IN DEXTROSE 5% | oxytocin | ABBOTT | NDA019185 | |
| OXYTROL | oxybutynin | ALLERGAN | NDA021351 | |
| OXYTROL FOR WOMEN | oxybutynin | ABBVIE | NDA202211 | |
| OZEMPIC | semaglutide | NOVO | NDA209637 | |
| OZEMPIC | semaglutide | NOVO | NDA213051 | |
| OZILTUS | denosumab-mobz | AMNEAL PHARMS LLC | BLA761457 | |
| OZOBAX DS | baclofen | METACEL PHARMS LLC | NDA208193 | |
| OZURDEX | dexamethasone | ABBVIE | NDA022315 |