All FDA drug approvals
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FDA drug approvals — brands starting with U
50 FDA applications with an approved original submission carry a brand starting with U, the earliest approved in 1948 and the most recent in 2026. FDA marks 22 of them discontinued, every product under the application. From the Drugs@FDA export of 2026-09-03.
| Brand | Ingredient | Approved | Sponsor | Application |
|---|---|---|---|---|
| UBRELVY | ubrogepant | ABBVIE | NDA211765 | |
| UCEPHAN | sodium benzoate, sodium phenylacetate | B BRAUN | NDA019530 | |
| UCERIS | budesonide | SALIX | NDA203634 | |
| UCERIS | budesonide | SALIX | NDA205613 | |
| UDENYCA | pegfilgrastim-cbqv | COHERUS BIOSCIENCES INC | BLA761039 | |
| UKONIQ | umbralisib tosylate | TG THERAPS | NDA213176 | |
| ULESFIA | benzyl alcohol | SHIONOGI | NDA022129 | |
| ULORIC | febuxostat | TAKEDA PHARMS USA | NDA021856 | |
| ULTANE | sevoflurane | ABBVIE | NDA020478 | |
| ULTIVA | remifentanil hydrochloride | MYLAN INSTITUTIONAL | NDA020630 | |
| ULTOMIRIS | ravulizumab-cwvz | ALEXION PHARM | BLA761108 | |
| ULTRA-TECHNEKOW V4 | technetium tc-99m sodium pertechnetate generator | CURIUM | NDA017243 | |
| ULTRACET | acetaminophen, tramadol hydrochloride | JANSSEN PHARMS | NDA021123 | |
| ULTRAM | tramadol hydrochloride | JANSSEN PHARMS | NDA020281 | |
| ULTRAM ER | tramadol hydrochloride | VALEANT PHARMS | NDA021692 | |
| ULTRATAG | technetium tc-99m red blood cell kit | CURIUM | NDA019981 | |
| ULTRAVATE | halobetasol propionate | SUN PHARM INDS INC | NDA019967 | |
| ULTRAVATE | halobetasol propionate | SUN PHARM INDS INC | NDA019968 | |
| ULTRAVATE | halobetasol propionate | LACER PHARMA | NDA208183 | |
| ULTRAVIST (PHARMACY BULK) | iopromide | BAYER HLTHCARE | NDA021425 | |
| ULTRAVIST 150 | iopromide | BAYER HLTHCARE | NDA020220 | |
| UNASYN | ampicillin sodium, sulbactam sodium | PFIZER | NDA050608 | |
| UNIPEN | nafcillin sodium | WYETH AYERST | NDA050111 | |
| UNIPEN | nafcillin sodium | WYETH AYERST | NDA050199 | |
| UNIPEN | nafcillin sodium | WYETH AYERST | NDA050320 | |
| UNIPEN | nafcillin sodium | WYETH AYERST | NDA050462 | |
| UNIRETIC | hydrochlorothiazide, moexipril hydrochloride | UCB INC | NDA020729 | |
| UNISOM | doxylamine succinate | CHATTEM | NDA018066 | |
| UNITHROID | levothyroxine sodium | STEVENS J | NDA021210 | |
| UNITUXIN | dinutuximab | UNITED THERAP | BLA125516 | |
| UNIVASC | moexipril hydrochloride | UCB INC | NDA020312 | |
| UNLOXCYT | cosibelimab-ipdl | CHECKPOINT THERAPEUTICS INC | BLA761297 | |
| UPLIZNA | inebilizumab-cdon | VIELA BIO | BLA761142 | |
| UPNEEQ | oxymetazoline hydrochloride | RVL PHARMS | NDA212520 | |
| UPTRAVI | selexipag | ACTELION | NDA207947 | |
| UPTRAVI | selexipag | ACTELION | NDA214275 | |
| URACIL MUSTARD | uracil mustard | SHIRE | NDA012892 | |
| UREAPHIL | urea | HOSPIRA | NDA012154 | |
| URECHOLINE | bethanechol chloride | TEVA BRANDED PHARM | NDA006536 | |
| UREX | methenamine hippurate | QUAGEN | NDA016151 | |
| URISPAS | flavoxate hydrochloride | ORTHO MCNEIL JANSSEN | NDA016769 | |
| UROCIT-K | potassium citrate | MISSION PHARMA | NDA019071 | |
| UROLOGIC G IN PLASTIC CONTAINER | citric acid, magnesium oxide, sodium carbonate | HOSPIRA | NDA018904 | |
| UROXATRAL | alfuzosin hydrochloride | ADVANZ PHARMA | NDA021287 | |
| URSO 250 | ursodiol | ABBVIE | NDA020675 | |
| UTEBZI | tebipenem pivoxil hydrobromide | GLAXOSMITHKLINE | NDA215960 | |
| UTIBRON NEOHALER | glycopyrrolate, indacaterol maleate | NOVARTIS | NDA207930 | |
| UTICORT | betamethasone benzoate | PARKE DAVIS | NDA016998 | |
| UVADEX | methoxsalen | THERAKOS DEVELOPMENT | NDA020969 | |
| UZEDY | risperidone | TEVA | NDA213586 |