Treats plaque psoriasis. NDA 213422, held by Mc2. Betamethasone Dipropionate; Calcipotriene.
As of Nov 13, 2026, NDA 213422 (Wynzora), held by Mc2, was first approved by FDA on Jul 20, 2020, with 0 approved supplements and 0 published complete response letters.
WYNZORA Cream is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 20, 2020 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Wynzora0.064%;0.005% · cream;topical | Betamethasone Dipropionate; Calcipotriene | 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
