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.
| Approved | Brand | Ingredient | Sponsor | Application |
|---|---|---|---|---|
| ISENTRESS | raltegravir potassium | MSD SUB MERCK | NDA205786 | |
| ORENITRAM | treprostinil diolamine | UNITED THERAP | NDA203496 | |
| KUVAN | sapropterin dihydrochloride | BIOMARIN PHARM | NDA205065 | |
| ADRENALIN | epinephrine | PH HEALTH | NDA204640 | |
| ANORO ELLIPTA | umeclidinium bromide, vilanterol trifenatate | GLAXOSMITHKLINE | NDA203975 | |
| SOVALDI | sofosbuvir | GILEAD SCIENCES INC | NDA204671 | |
| VELPHORO | ferric oxyhydroxide | VIFOR FRESENIUS | NDA205109 | |
| NOXAFIL | posaconazole | MERCK SHARP DOHME | NDA205053 | |
| VARITHENA | polidocanol | BOSTON SCITFC | NDA205098 | |
| OLYSIO | simeprevir sodium | JANSSEN PRODS | NDA205123 | |
| LUZU | luliconazole | BAUSCH | NDA204153 | |
| IMBRUVICA | ibrutinib | PHARMACYCLICS LLC | NDA205552 | |
| APTIOM | eslicarbazepine acetate | SUMITOMO PHARMA AM | NDA022416 | |
| GAZYVA | obinutuzumab | GENENTECH | BLA125486 | |
| MORPHINE SULFATE | morphine sulfate | FRESENIUS KABI USA | NDA204223 | |
| VIZAMYL | flutemetamol f-18 | GE HEALTHCARE | NDA203137 | |
| ZOHYDRO ER | hydrocodone bitartrate | RECRO GAINESVILLE | NDA202880 | |
| ECOZA | econazole nitrate | RESILIA PHARMS | NDA205175 | |
| ACTEMRA | tocilizumab | GENENTECH | BLA125472 | |
| OPSUMIT | macitentan | ACTELION | NDA204410 | |
| ZORVOLEX | diclofenac | ZYLA | NDA204592 | |
| DESVENLAFAXINE | desvenlafaxine fumarate | TEVA PHARMS USA | NDA205208 | |
| OTREXUP | methotrexate | COSETTE | NDA204824 | |
| ADEMPAS | riociguat | BAYER HLTHCARE | NDA204819 | |
| CLINOLIPID 20% | olive oil, soybean oil | BAXTER HLTHCARE CORP | NDA204508 | |
| DUAVEE | bazedoxifene acetate, estrogens, conjugated | WYETH PHARMS | NDA022247 | |
| TRINTELLIX | vortioxetine hydrobromide | TAKEDA PHARMS USA | NDA204447 | |
| CYCLOPHOSPHAMIDE | cyclophosphamide | HIKMA | NDA203856 | |
| CARBON DIOXIDE, USP | carbon dioxide | AIRGAS USA LLC | NDA206025 | |
| HELIUM, USP | helium | AIR LIQUIDE HEALTHCARE AMERICA CORP | NDA206026 | |
| NITROGEN, NF | nitrogen | AIRGAS USA LLC | NDA206024 | |
| OXYGEN, USP | oxygen | AIRGAS USA LLC | NDA206023 | |
| NITROUS OXIDE, USP | nitrous oxide | NITROUS OXIDE OF CANADA | NDA206014 | |
| NITROUS OXIDE, USP | nitrous oxide | NITROUS OXIDE CORP | NDA206009 | |
| MEDICAL AIR, USP | medical air | ACETYLENE OXYGENE CO | NDA205999 | |
| MEDICAL AIR, USP | medical air | UNITED STATES WELDING INC | NDA205992 | |
| NITROGEN, NF | nitrogen | PRAXAIR CANADA INC | NDA205985 | |
| OXYGEN, USP | oxygen | PRAXAIR CANADA INC | NDA205986 | |
| MIRVASO | brimonidine tartrate | GALDERMA LABS LP | NDA204708 | |
| VALCHLOR | mechlorethamine hydrochloride | HELSINN | NDA202317 | |
| TROKENDI XR | topiramate | SUPERNUS PHARMS | NDA201635 | |
| EPANED KIT | enalapril maleate | AZURITY | NDA204308 | |
| TIVICAY | dolutegravir sodium | VIIV HLTHCARE | NDA204790 | |
| ESOMEPRAZOLE STRONTIUM | esomeprazole strontium | BELCHER | NDA202342 | |
| HELIUM, USP | helium | PRAXAIR DISTRIBUTION MID-ATLANTIC LLC | NDA205911 | |
| HELIUM, USP | helium | PRAXAIR DISTRIBUTION INC | NDA205912 | |
| MEDICAL AIR, USP | medical air | PRAXAIR DISTRIBUTION INC | NDA205909 | |
| MEDICAL AIR, USP | medical air | PRAXAIR DISTRIBUTION MID-ATLANTIC LLC | NDA205910 | |
| MEDICAL AIR, USP | medical air | MATHESON TRI-GAS INC | NDA205890 | |
| NITROGEN, NF | nitrogen | MATHESON TRI-GAS INC | NDA205891 | |
| OXYGEN, USP | oxygen | MATHESON TRI-GAS INC | NDA205889 | |
| ZOLEDRONIC ACID | zoledronic acid | INFORLIFE | NDA203231 | |
| FETZIMA | levomilnacipran hydrochloride | ABBVIE | NDA204168 | |
| INJECTAFER | ferric carboxymaltose | AM REGENT | NDA203565 | |
| LO MINASTRIN FE | ethinyl estradiol, norethindrone acetate | APIL | NDA204654 | |
| MEDICAL AIR, USP | medical air | NEXAIR | NDA205859 | |
| NITROGEN, NF | nitrogen | ASPEN AIR | NDA205863 | |
| NITROGEN, NF | nitrogen | AIR PRODUCTS AND CHEMICALS INC | NDA205866 | |
| OXYGEN, USP | oxygen | ASPEN AIR | NDA205862 | |
| OXYGEN, USP | oxygen | AIR PRODUCTS AND CHEMICALS INC | NDA205865 | |
| CARBON DIOXIDE, USP | carbon dioxide | PRAXAIR INC | NDA205852 | |
| HELIUM, USP | helium | PRAXAIR INC | NDA205851 | |
| NITROGEN, NF | nitrogen | PRAXAIR INC | NDA205850 | |
| OXYGEN, USP | oxygen | PRAXAIR INC | NDA205849 | |
| CARBON DIOXIDE, USP | carbon dioxide | AIRGAS CARBONIC INC | NDA205846 | |
| HELIUM, USP | helium | AIRGAS USA LLC | NDA205843 | |
| MEDICAL AIR, USP | medical air | AIRGAS USA LLC | NDA205845 | |
| MEDICAL AIR, USP | medical air | OXARC INC | NDA205847 | |
| ASTAGRAF XL | tacrolimus | ASTELLAS | NDA204096 | |
| SIMPONI ARIA | golimumab | JANSSEN BIOTECH | BLA125433 | |
| NITROGEN, NF | nitrogen | AIRGAS MERCHANTS GASES LLC | NDA205839 | |
| OXYGEN, USP | oxygen | AIRGAS MERCHANTS GASES LLC | NDA205840 | |
| MEDICAL AIR, USP | medical air | DUPUY OXYGEN | NDA205826 | |
| HELIUM, USP | helium | NORCO INC | NDA205819 | |
| MEDICAL AIR, USP | medical air | WYNN L MADER, INDUSTRIAL GAS DISTRIBUTORS | NDA205803 | |
| MEDICAL AIR, USP | medical air | PURITY CYLINDER GASES, INC | NDA205804 | |
| MEDICAL AIR, USP | medical air | WESTAIR GASES & EQUIPMENT INC | NDA205809 | |
| MEDICAL AIR, USP | medical air | SCOTT-GROSS COMPANY | NDA205821 | |
| NITROGEN, NF | nitrogen | NORCO INC | NDA205805 | |
| OXYGEN, USP | oxygen | NORCO INC | NDA205820 | |
| MEDICAL AIR, USP | medical air | MACHINE & WELDING SUPPLY CO | NDA205796 | |
| MEDICAL AIR, USP | medical air | AIR LIQUIDE AMERICA LP | NDA205828 | |
| NITROGEN, NF | nitrogen | AIR LIQUIDE AMERICA LP | NDA205829 | |
| OXYGEN, USP | oxygen | AIR LIQUIDE AMERICA LP | NDA205827 | |
| GILOTRIF | afatinib dimaleate | BOEHRINGER INGELHEIM | NDA201292 | |
| KHEDEZLA | desvenlafaxine | OSMOTICA PHARM CORP | NDA204683 | |
| CARBON DIOXIDE, USP | carbon dioxide | LINDE NORTH AMERICA INC | NDA205764 | |
| CARBON DIOXIDE, USP | carbon dioxide | LINDE MERCHANT PRODUCTIONS INC | NDA205815 | |
| MEDICAL AIR, USP | medical air | LINDE NORTH AMERICA INC | NDA205765 | |
| NITROGEN, NF | nitrogen | LINDE NORTH AMERICA INC | NDA205766 | |
| NITROGEN, NF | nitrogen | LINDE GAS PUERTO RICO INC | NDA205816 | |
| 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 | |
| ZUBSOLV | buprenorphine hydrochloride, naloxone hydrochloride | EDENBRIDGE PHARMS | NDA204242 | |
| BRISDELLE | paroxetine mesylate | LEGACY | NDA204516 | |
| NAFTIN | naftifine hydrochloride | LEGACY | NDA204286 | |
| NITROGEN, NF | nitrogen | AIR LIQUIDE LARGE INDUSTRIES US LP | NDA205738 | |
| OXYGEN, USP | oxygen | AIR LIQUIDE LARGE INDUSTRIES US LP | NDA205737 | |
| VIBATIV | telavancin | THERAVANCE INC | NDA022407 | |
| ZEGERID OTC | omeprazole, sodium bicarbonate | RILEY CONSUMER | NDA022283 | |
| MEDICAL AIR, USP | medical air | AIR LIQUIDE AMERICA SPECIALITY GASES | NDA205711 | |
| NITROUS OXIDE, USP | nitrous oxide | AIR LIQUIDE AMERICA SPECIALITY GASES | NDA205704 | |
| OXYGEN, USP | oxygen | AIR LIQUID INDUSTRIAL US LP | NDA205712 | |
| OXYGEN, USP | oxygen | AIR LIQUID INDUSTRIAL US LP | NDA205713 | |
| BLOXIVERZ | neostigmine methylsulfate | EXELA PHARMA | NDA204078 | |
| MEKINIST | trametinib dimethyl sulfoxide | NOVARTIS | NDA204114 | |
| TAFINLAR | dabrafenib mesylate | NOVARTIS | NDA202806 | |
| XOFIGO | radium ra-223 dichloride | BAYER HLTHCARE | NDA203971 | |
| BREO ELLIPTA | fluticasone furoate, vilanterol trifenatate | GLAXO GRP LTD | NDA204275 | |
| NYMALIZE | nimodipine | AZURITY | NDA203340 | |
| MINASTRIN 24 FE | ethinyl estradiol, norethindrone acetate | APIL | NDA203667 | |
| LIPTRUZET | atorvastatin calcium, ezetimibe | ORGANON | NDA200153 | |
| PROCYSBI | cysteamine bitartrate | HORIZON | NDA203389 | |
| SIMBRINZA | brimonidine tartrate, brinzolamide | ALCON LABS INC | NDA204251 | |
| TAYTULLA | ethinyl estradiol, norethindrone acetate | APIL | NDA204426 | |
| DOCETAXEL | docetaxel | ACTAVIS | NDA203551 | |
| SITAVIG | acyclovir | LIGAND PHARMS | NDA203791 | |
| TOPICORT | desoximetasone | SUN PHARMA CANADA | NDA204141 | |
| DICLEGIS | doxylamine succinate, pyridoxine hydrochloride | DUCHESNAY | NDA021876 | |
| PROLENSA | bromfenac sodium | BAUSCH AND LOMB | NDA203168 | |
| INVOKANA | canagliflozin | JANSSEN PHARMS | NDA204042 | |
| KARBINAL ER | carbinoxamine maleate | AYTU | NDA022556 | |
| QUARTETTE | ethinyl estradiol, levonorgestrel | TEVA BRANDED PHARM | NDA204061 | |
| TECFIDERA | dimethyl fumarate | BIOGEN | NDA204063 | |
| ACIPHEX SPRINKLE | rabeprazole sodium | AYTU | NDA204736 | |
| TOBI PODHALER | tobramycin | VIATRIS | NDA201688 | |
| PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | PARAGON BIOTECK | NDA203510 | |
| DOTAREM | gadoterate meglumine | GUERBET | NDA204781 | |
| LYMPHOSEEK KIT | technetium tc-99m tilmanocept | CARDINAL HEALTH 414 | NDA202207 | |
| DESVENLAFAXINE | desvenlafaxine | ALEMBIC PHARMS LTD | NDA204150 | |
| ABILIFY MAINTENA KIT | aripiprazole | OTSUKA PHARM CO LTD | NDA202971 | |
| OSPHENA | ospemifene | DUCHESNAY | NDA203505 | |
| STIVARGA | regorafenib | BAYER HEALTHCARE PHARMS | NDA204369 | |
| KADCYLA | ado-trastuzumab emtansine | GENENTECH | BLA125427 | |
| SUPRAX | cefixime | LUPIN LTD | NDA202091 | |
| VITUZ | chlorpheniramine maleate, hydrocodone bitartrate | PERSION | NDA204307 | |
| POMALYST | pomalidomide | BRISTOL | NDA204026 | |
| VERSACLOZ | clozapine | DOUGLAS PHARMS | NDA203479 | |
| DELZICOL | mesalamine | ABBVIE | NDA204412 | |
| RAVICTI | glycerol phenylbutyrate | HORIZON THERAP US | NDA203284 | |
| TESTOSTERONE | testosterone | PERRIGO ISRAEL | NDA203098 | |
| KYNAMRO | mipomersen sodium | KASTLE THERAPS LLC | NDA203568 | |
| KAZANO | alogliptin benzoate, metformin hydrochloride | TAKEDA PHARMS USA | NDA203414 | |
| NESINA | alogliptin benzoate | TAKEDA PHARMS USA | NDA022271 | |
| OSENI | alogliptin benzoate, pioglitazone hydrochloride | TAKEDA PHARMS USA | NDA022426 | |
| OXYTROL FOR WOMEN | oxybutynin | ABBVIE | NDA202211 | |
| SUCLEAR | magnesium sulfate, polyethylene glycol 3350, potassium chloride, potassium sulfate, sodium bicarbonate, sodium chloride, sodium sulfate | BRAINTREE LABS | NDA203595 | |
| ZECUITY | sumatriptan succinate | TEVA BRANDED PHARM | NDA202278 | |
| UCERIS | budesonide | SALIX | NDA203634 | |
| VAZALORE | aspirin | PLX PHARMA | NDA203697 | |
| SKYLA | levonorgestrel | BAYER HLTHCARE | NDA203159 |