Treats acne vulgaris. NDA 207917, held by Galderma Labs. Adapalene; Benzoyl Peroxide.
As of Nov 13, 2026, NDA 207917 (Epiduo Forte), held by Galderma Labs, was first approved by FDA on Jul 15, 2015, with 2 approved supplements and 0 published complete response letters.
Adapalene and Benzoyl Peroxide gel is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 15, 2015 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Epiduo Forte0.3%;2.5% · gel;topical | Adapalene; Benzoyl Peroxide | RxReference drug |
| Apr 27, 2022 | Supplement 4Labeling · Standard review | Approved | |
| Apr 27, 2022 | Supplement 8Labeling · Standard review | Approved | |
| Jul 15, 2015 | Original applicationNew formulation or manufacturer · Standard review | 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
