Treats plaque psoriasis. ANDA 208662, held by Cosette Pharms Nc. Tazarotene.
As of Nov 15, 2026, ANDA 208662 (Tazarotene), held by Cosette Pharms Nc, was first approved by FDA on Dec 22, 2017, with 1 approved supplement and 0 published complete response letters.
Tazarotene cream 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis. Tazarotene cream 0.1% is indicated for the topical treatment of acne vulgaris. 1.1 Plaque Psoriasis Tazarotene cream, 0.1% is indicated for the topical treatment of patients with plaque psoriasis. 1.2 Acne Vulgaris Tazarotene cream, 0.1% is also indicated for the topical treatment of patients with acne vulgaris.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 22, 2017 | Original application | Approved | None posted |
| Tazarotene0.1% · cream;topical | Tazarotene | Rx |
| Tazarotene0.05% · cream;topical | Tazarotene | Rx |
| Mar 10, 2025 | Supplement 7Manufacturing | Approved | None posted |
| Dec 22, 2017 | Original application | Approved | None posted |
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
