ANDA 80839, held by Inwood Labs. Methyltestosterone.
As of Nov 14, 2026, ANDA 80839 (Methyltestosterone), held by Inwood Labs, was first approved by FDA on Jul 24, 1972, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 24, 1972 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Methyltestosterone10MG ยท tablet;oral | Methyltestosterone | 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
