ANDA 88342, held by Upsher Smith Labs. Fluoxymesterone.
As of Nov 13, 2026, ANDA 88342 (Fluoxymesterone), held by Upsher Smith Labs, was first approved by FDA on Oct 21, 1983, with 17 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 21, 1983 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fluoxymesterone10MG ยท tablet;oral | Fluoxymesterone | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 6, 1992 | Supplement 25Labeling | Approved | None posted |
| Dec 11, 1991 | Supplement 24Labeling | Approved | None posted |
| Jul 2, 1991 | Supplement 22Labeling | Approved | None posted |
| Mar 8, 1990 | Supplement 21Labeling | Approved | None posted |
| Nov 7, 1989 | Supplement 20Labeling | Approved | None posted |
| Jan 12, 1989 | Supplement 19Labeling | Approved | None posted |
| May 26, 1988 | Supplement 17Manufacturing | Approved | None posted |
| Dec 26, 1987 | Supplement 18Manufacturing | Approved | None posted |
| Sep 17, 1986 | Supplement 14Manufacturing | Approved | None posted |
| Sep 17, 1986 | Supplement 13Manufacturing | Approved | None posted |
| Sep 17, 1986 | Supplement 12Manufacturing | Approved | None posted |
| Aug 27, 1986 | Supplement 9Manufacturing | Approved | None posted |
| Mar 20, 1986 | Supplement 10Manufacturing | Approved | None posted |
| Jul 17, 1984 | Supplement 4Manufacturing | Approved | None posted |
| Jul 17, 1984 | Supplement 3Manufacturing | Approved | None posted |
| Jul 17, 1984 | Supplement 2Manufacturing | Approved | None posted |
| Jul 17, 1984 | Supplement 1Manufacturing | Approved | None posted |
| Oct 21, 1983 | 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
