Treats acne vulgaris. ANDA 201000, held by Actavis Mid Atlantic. Adapalene.
As of Nov 14, 2026, ANDA 201000 (Adapalene), held by Actavis Mid Atlantic, was first approved by FDA on Oct 27, 2014, with 2 approved supplements and 0 published complete response letters.
Adapalene gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 27, 2014 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Adapalene0.3% · gel;topical | Adapalene | Rx |
| Aug 26, 2024 | Supplement 7Labeling · Standard review | Approved | None posted |
| Apr 11, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| Oct 27, 2014 | Original application | 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
