Treats acne vulgaris. ANDA 90824, held by Fougera Pharms. Adapalene.
As of Nov 14, 2026, ANDA 90824 (Adapalene), held by Fougera Pharms, was first approved by FDA on Jun 30, 2010, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE: Adapalene cream is indicated for the topical treatment of acne vulgaris.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 30, 2010 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Adapalene0.1% · cream;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
