Sold as Halotestin, Ora-Testryl. Every FDA application for this active ingredient: 2 branded and 6 generic.
As of Nov 13, 2026, FDA lists 8 applications for Fluoxymesterone (sold as Halotestin, Ora-Testryl), first approved Oct 15, 1956, with 0 new uses approved and 0 published complete response letters.
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Oct 15, 1956 | HalotestinNDA 10611 · New molecular entity | Pharmacia And Upjohn | 8 | Discontinued |
| Jul 6, 1981 | Android-FANDA 87196 | Valeant Pharm Intl | 0 | Discontinued |
| May 5, 1983 | FluoxymesteroneANDA 88221 | Valeant Pharm Intl | 0 | Discontinued |
| Oct 21, 1983 | FluoxymesteroneANDA 88342 | Upsher Smith Labs | 17 | Discontinued |
| — | FluoxymesteroneANDA 88260 | Watson Labs | 0 | Discontinued |
| — | FluoxymesteroneANDA 88265 | Watson Labs | 0 | Discontinued |
| — | FluoxymesteroneANDA 88309 | Watson Labs | 0 | Discontinued |
| — | Ora-TestrylNDA 11359 | Bristol Myers Squibb | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number. Drugs@FDA
Bristol Myers Squibb