Treats acne. ANDA 91314, held by Glenmark Pharms. Adapalene.
As of Nov 14, 2026, ANDA 91314 (Adapalene), held by Glenmark Pharms, was first approved by FDA on Jul 1, 2010, with 1 approved supplement and 0 published complete response letters.
USE for the treatment of acne
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 1, 2010 | Original application | Approved |
| Jul 9, 2019 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jul 1, 2010 | Original application | Approved |
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
