Treats inflammatory lesions of rosacea. NDA 214510, held by Mayne Pharma. Benzoyl Peroxide.
As of Nov 13, 2026, NDA 214510 (Epsolay), held by Mayne Pharma, was first approved by FDA on Apr 22, 2022, with 0 approved supplements and 0 published complete response letters.
EPSOLAY is indicated for the treatment of inflammatory lesions of rosacea in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 22, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Epsolay5% · cream;topical | Benzoyl Peroxide | RxReference drug |
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
