Treats acne vulgaris. ANDA 200298, held by Encube Ethicals. Adapalene.
As of Nov 15, 2026, ANDA 200298 (Adapalene), held by Encube Ethicals, was first approved by FDA on Jun 14, 2012, with 0 approved supplements and 0 published complete response letters.
ADAPALENE Gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 14, 2012 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Adapalene0.3% · gel;topical | Adapalene | Rx |
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
