NDA 20834, held by Kenvue Brands. Minoxidil.
As of Nov 13, 2026, NDA 20834 (Rogaine Extra Strength (For Men)), held by Kenvue Brands, was first approved by FDA on Nov 14, 1997, with 7 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 carton)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 14, 1997 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rogaine Extra Strength (For Men)5% · solution;topical | Minoxidil | OTCReference drug |
| Jan 14, 2026 | Supplement 21Labeling · Standard review | Approved | |
| Apr 27, 2015 | Supplement 14Labeling · Standard review | Approved | |
| Sep 12, 2006 | Supplement 11Labeling · Standard review | Approved | |
| May 31, 2005 | Supplement 9Labeling · Standard review | Approved | |
| Jun 25, 2004 | Supplement 7Manufacturing · Standard review | Approved | |
| Feb 14, 2003 | Supplement 3Labeling · Standard review | Approved | |
| Apr 16, 1998 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Nov 14, 1997 | 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
