ANDA 76239, held by Pure Source. Minoxidil.
As of Nov 15, 2026, ANDA 76239 (Theroxidil), held by Pure Source, was first approved by FDA on Aug 24, 2004, with 2 approved supplements and 0 published complete response letters.
1 Bottle Carton Use to regrow hair on the scalp (vertex only, see picture on side of carton) 3 Bottle Carton Use to regrow hair on the scalp (vertex only, see picture on side of carton)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 24, 2004 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Theroxidil5% · solution;topical | Minoxidil | OTC |
| Jul 21, 2016 | Supplement 8Manufacturing | Approved | None posted |
| Jul 21, 2016 | Supplement 10Labeling | Approved | None posted |
| Aug 24, 2004 | 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
