Sold as Doriden. Every FDA application for this active ingredient: 1 branded and 9 generic.
As of Nov 14, 2026, FDA lists 10 applications for Glutethimide (sold as Doriden), first approved Apr 16, 1957, with 0 new uses approved and 0 published complete response letters.
| Apr 16, 1957 | DoridenNDA 9519 · New molecular entity | Sanofi Aventis US | 3 | Discontinued |
| Oct 28, 1976 | GlutethimideANDA 83234 | Upsher Smith Labs | 15 | Discontinued |
| Apr 1, 1977 | GlutethimideANDA 83475 | Lannett | 0 | Discontinued |
| Aug 1, 1977 | GlutethimideANDA 84362 | Watson Labs | 0 | Discontinued |
| Aug 2, 1977 | GlutethimideANDA 85763 | Watson Labs | 1 | Discontinued |
| Aug 26, 1977 | GlutethimideANDA 85571 | Lannett | 0 | Discontinued |
| Apr 20, 1981 | GlutethimideANDA 87297 | Vitarine | 0 | Discontinued |
| Oct 10, 1986 | GlutethimideANDA 89459 | Halsey | 1 | Discontinued |
| — | GlutethimideANDA 85171 | Ucb Inc | 0 | Discontinued |
| — | GlutethimideANDA 89458 | Halsey | 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; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Sanofi Aventis US