ANDA 218616, held by Aurobindo Pharma. Minoxidil.
As of Nov 15, 2026, ANDA 218616 (Minoxidil (For Men), Minoxidil (For Women)), held by Aurobindo Pharma, was first approved by FDA on Apr 22, 2024, with 0 approved supplements and 0 published complete response letters.
Use to regrow hair on the top of the scalp (see pictures on side of this carton)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 22, 2024 | 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
