Treats plaque psoriasis of up to 20% body surface area involvement. ANDA 215433, held by Cosette Pharms Nc. Tazarotene.
As of Nov 15, 2026, ANDA 215433 (Tazarotene), held by Cosette Pharms Nc, was first approved by FDA on Sep 13, 2022, with 0 approved supplements and 0 published complete response letters.
Tazarotene gel, 0.05% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. Limitations of Use The safety of tazarotene gel use on more than 20% body surface area has not been established. 1.1 Plaque Psoriasis Tazarotene gel, 0.05% is indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement. 1.3 Limitations of Use The safety of tazarotene gel use on more than 20% body surface area has not been established in psoriasis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 13, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tazarotene0.05% · gel;topical | Tazarotene | 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
