Treats acne vulgaris. NDA 214902, held by Mayne Pharma. Benzoyl Peroxide; Tretinoin.
As of Nov 13, 2026, NDA 214902 (Twyneo), held by Mayne Pharma, was first approved by FDA on Jul 26, 2021, with 0 approved supplements and 0 published complete response letters.
TWYNEO is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 26, 2021 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Twyneo3%;0.1% · cream;topical | Benzoyl Peroxide; Tretinoin | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
