ANDA 75839, held by Apotex Inc. Minoxidil.
As of Nov 15, 2026, ANDA 75839 (Minoxidil Extra Strength (For Men)), held by Apotex Inc, was first approved by FDA on Oct 1, 2001, with 6 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 1, 2001 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Minoxidil Extra Strength (For Men)5% ยท solution;topical | Minoxidil | Discontinued |
| Mar 15, 2007 | Supplement 13Labeling | Approved | None posted |
| Apr 12, 2005 | Supplement 8Labeling | Approved | None posted |
| Aug 29, 2003 | Supplement 6Labeling | Approved | None posted |
| Dec 9, 2002 | Supplement 4Manufacturing | Approved | None posted |
| Feb 15, 2002 | Supplement 1Manufacturing | Approved | None posted |
| Feb 15, 2002 | Supplement 2Manufacturing | Approved | None posted |
| Oct 1, 2001 | Original application | Approved |
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
