ANDA 78176, held by Pure Source. Minoxidil.
As of Nov 15, 2026, ANDA 78176 (Theroxidil), held by Pure Source, was first approved by FDA on Nov 9, 2007, with 1 approved supplement and 0 published complete response letters.
USE Use to regrow hair on the scalp
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 9, 2007 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Theroxidil2% · solution;topical | Minoxidil | OTC |
| Jul 21, 2016 | Supplement 6Manufacturing | Approved | None posted |
| Nov 9, 2007 | 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
