NDA 21812, held by Kenvue Brands. Minoxidil.
As of Nov 14, 2026, NDA 21812 (Men'S Rogaine, Women'S Rogaine), held by Kenvue Brands, was first approved by FDA on Jan 20, 2006, with 9 approved supplements and 0 published complete response letters.
Use to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)
| Feb 28, 2014 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Jan 20, 2006 | Original applicationNew dosage form · Standard review | Approved |
| Jan 14, 2026 | Supplement 20Labeling · Standard review | Approved | |
| Dec 29, 2020 | Supplement 16Labeling · Standard review | Approved | |
| Jan 31, 2020 | Supplement 15Labeling · Standard review | Approved | |
| Jun 11, 2019 | Supplement 14Labeling · Standard review | Approved | |
| Feb 10, 2015 | Supplement 11Labeling · Standard review | Approved | |
| Feb 28, 2014 | Supplement 9Efficacy (new indication or use) · Standard review | Approved | |
| Dec 13, 2013 | Supplement 10Labeling · Standard review | Approved | |
| Nov 30, 2012 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| May 22, 2006 | Supplement 1Labeling · Standard review | Approved | |
| Jan 20, 2006 | Original applicationNew dosage form · Standard review | 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
