ANDA 80256, held by Lilly. Methyltestosterone.
As of Nov 14, 2026, ANDA 80256 (Methyltestosterone), held by Lilly, was first approved by FDA on Dec 22, 1971, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 22, 1971 | Original application | Approved | None posted |
| Methyltestosterone10MG · tablet;buccal, sublingual | Methyltestosterone | Discontinued |
| Methyltestosterone25MG · tablet;buccal, sublingual | 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
