Treats acne vulgaris. ANDA 208322, held by Sun Pharma Canada. Adapalene.
As of Nov 15, 2026, ANDA 208322 (Adapalene), held by Sun Pharma Canada, was first approved by FDA on Jun 23, 2016, with 2 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 23, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Adapalene0.3% · gel;topical | Adapalene | Rx |
| Jun 17, 2024 | Supplement 7Labeling · Standard review | Approved | None posted |
| Dec 14, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jun 23, 2016 | Original application | Approved | None posted |
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
