Treats acne. ANDA 215940, held by Sun Pharma Canada. Adapalene.
As of Nov 14, 2026, ANDA 215940 (Adapalene), held by Sun Pharma Canada, was first approved by FDA on Jan 14, 2022, with 1 approved supplement and 0 published complete response letters.
Use For the treatment of acne
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 14, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Adapalene0.1% · gel;topical | Adapalene | OTC |
| Jul 6, 2023 | Supplement 1Manufacturing | Approved | None posted |
| Jan 14, 2022 | 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
