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As of Nov 15, 2026, ANDA 75518 (Minoxidil Extra Strength (For Men)), held by P And L, was first approved by FDA on Nov 17, 2000, with 8 approved supplements and 0 published complete response letters.
First approved: Nov 17, 2000
Supplements approved: 8
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)
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
