ANDA 85125, held by Tablicaps. Methyltestosterone.
As of Nov 14, 2026, ANDA 85125 (Methyltestosterone), held by Tablicaps, was first approved by FDA on Feb 2, 1977, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 2, 1977 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Methyltestosterone10MG ยท 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
