Treats plaque psoriasis. NDA 21184, held by Chartwell Rx. Tazarotene.
As of Nov 14, 2026, NDA 21184 (Tazorac, Avage), held by Chartwell Rx, was first approved by FDA on Sep 29, 2000, with 5 approved supplements and 0 published complete response letters.
TAZORAC Cream 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis. TAZORAC Cream 0.1% is indicated for the topical treatment of acne vulgaris. 1.1 Plaque Psoriasis TAZORAC (tazarotene) Cream, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis. 1.2 Acne Vulgaris TAZORAC (tazarotene) Cream, 0.1% is also indicated for the topical treatment of patients with acne vulgaris.
| Sep 30, 2002 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Oct 11, 2001 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Sep 29, 2000 | Original applicationNew dosage form · Standard review | Approved |
| Tazorac0.05% · cream;topical | Tazarotene | RxReference drug |
| Tazorac0.1% · cream;topical | Tazarotene | RxReference drug |
| Avage0.1% · cream;topical | Tazarotene | RxReference drug |
| Jul 21, 2017 | Supplement 9Labeling · Standard review | Approved | |
| Sep 16, 2016 | Supplement 8Labeling · Standard review | Approved | |
| Dec 13, 2013 | Supplement 7Labeling · Standard review | Approved | |
| Sep 30, 2002 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Oct 11, 2001 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Sep 29, 2000 | Original applicationNew dosage form · Standard review | Approved |
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
