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Treats acne vulgaris. NDA 207154, held by Almirall. Dapsone.
As of Nov 13, 2026, NDA 207154 (Aczone), held by Almirall, was first approved by FDA on Feb 24, 2016, with 2 approved supplements and 0 published complete response letters.
First approved: Feb 24, 2016
Review: Standard
Supplements approved: 2
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
ACZONE (dapsone) Gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
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
