ANDA 84310, held by Impax Labs. Methyltestosterone.
As of Nov 14, 2026, ANDA 84310 (Methyltestosterone), held by Impax Labs, was first approved by FDA on Jun 21, 1974, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 21, 1974 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Methyltestosterone25MG · tablet;oral | Methyltestosterone | Discontinued |
| May 11, 2015 | Supplement 78Labeling · Standard review | Approved | None posted |
| Jun 19, 2014 | Supplement 77Labeling · Standard review | Approved | None posted |
| Nov 4, 2002 | Supplement 76Labeling | Approved | None posted |
| May 7, 2002 | Supplement 75Labeling | Approved | None posted |
| May 7, 2002 | Supplement 74Manufacturing | Approved | None posted |
| Mar 10, 2000 | Supplement 72Labeling | Approved | None posted |
| Aug 13, 1999 | Supplement 73Manufacturing | Approved | None posted |
| Oct 29, 1997 | Supplement 71Labeling | Approved | None posted |
| Oct 9, 1991 | Supplement 70Labeling | Approved | None posted |
| Jul 5, 1991 | Supplement 69Labeling | Approved | None posted |
| Jul 5, 1991 | Supplement 68Labeling | Approved | None posted |
| Jan 19, 1990 | Supplement 67Labeling | Approved | None posted |
| Oct 23, 1989 | Supplement 65Labeling | Approved | None posted |
| Jun 22, 1989 | Supplement 64Labeling | Approved | None posted |
| Oct 31, 1988 | Supplement 63Labeling | Approved | None posted |
| Jul 6, 1988 | Supplement 62Labeling | Approved | None posted |
| Jun 21, 1974 | Original application | Approved | None posted |
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
