ANDA 80475, held by Purepac Pharm. Methyltestosterone.
As of Nov 14, 2026, ANDA 80475 (Methyltestosterone), held by Purepac Pharm, was not approved, with 0 approved supplements and 0 published complete response letters.
| Methyltestosterone10MG · tablet;buccal, sublingual | Methyltestosterone | Discontinued |
| 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
