ANDA 75438, held by Aurobindo Pharma Ltd. Minoxidil.
As of Nov 15, 2026, ANDA 75438 (Minoxidil Extra Strength (For Men)), held by Aurobindo Pharma Ltd, was first approved by FDA on Feb 27, 2003, with 0 approved supplements and 0 published complete response letters.
INDICATIONS % USAGE SECTION
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 27, 2003 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Minoxidil Extra Strength (For Men)5% · solution;topical | Minoxidil | OTC |
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
