ANDA 203981, held by Waylis Therap. Adapalene.
As of Nov 14, 2026, ANDA 203981 (Adapalene), held by Waylis Therap, was first approved by FDA on Sep 23, 2016, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 23, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Adapalene0.1% ยท solution;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
