Treats acne vulgaris. ANDA 204593, held by Waylis Therap. Adapalene.
As of Nov 15, 2026, ANDA 204593 (Adapalene), held by Waylis Therap, was first approved by FDA on Jan 5, 2016, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Adapalene Topical Solution, 0.1% is indicated for the topical treatment of acne vulgaris.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 5, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Adapalene0.1% · solution;topical | Adapalene | Rx |
| Jul 11, 2017 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 5, 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
