ANDA 88221, held by Valeant Pharm Intl. Fluoxymesterone.
As of Nov 13, 2026, ANDA 88221 (Fluoxymesterone), held by Valeant Pharm Intl, was first approved by FDA on May 5, 1983, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 5, 1983 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fluoxymesterone10MG ยท tablet;oral | Fluoxymesterone | Discontinued |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
