Sold as Ovulen, Ovulen-21, Ovulen-28. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 2 applications for Ethynodiol Diacetate; Mestranol (sold as Ovulen, Ovulen-21, Ovulen-28), first approved Mar 23, 1966, with 0 new uses approved and 0 published complete response letters.
| Mar 23, 1966 | Ovulen, Ovulen-21NDA 16029 · New molecular entity, new combination | Gd Searle LLC | 13 | Discontinued |
| Oct 2, 1967 | Ovulen-28NDA 16705 · New dosage form | Gd Searle LLC | 9 | 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
