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As of Nov 15, 2026, ANDA 213508 (Adapalene), held by Alembic, was first approved by FDA on Jun 18, 2020, with 1 approved supplement and 0 published complete response letters.
First approved: Jun 18, 2020
Review: Standard
Supplements approved: 1
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Adapalene gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 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
