Tazorac

Treats plaque psoriasis of up to 20% body surface area involvement. NDA 20600, held by Chartwell Rx. Tazarotene.

As of Nov 13, 2026, NDA 20600 (Tazorac), held by Chartwell Rx, was first approved by FDA on Jun 13, 1997, with 7 approved supplements and 0 published complete response letters.

First approved: Jun 13, 1997
Review: Standard
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TAZORAC Gel, 0.05% and 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. TAZORAC Gel, 0.1% is indicated for the topical treatment of mild to moderate facial acne vulgaris. Limitations of Use The safety of TAZORAC Gel use on more than 20% body surface area has not been established. 1.1 Plaque Psoriasis TAZORAC (tazarotene) Gel, 0.05% and 0.1% are indicated for the topical treatment of patients with plaque psoriasis of up to 20% body surface area involvement. 1.2 Acne Vulgaris TAZORAC (tazarotene) Gel, 0.1% is also indicated for the topical treatment of patients with facial acne vulgaris of mild to moderate severity.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jun 13, 1997	Original applicationNew molecular entity · Standard review	Approved	Review

Products

2 strengths and forms

Product	Active ingredient	Marketing
Tazorac0.05% · gel;topical	Tazarotene	RxReference drug
Tazorac0.1% · gel;topical	Tazarotene	RxReference drug

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 16, 2018	Supplement 10Labeling · Standard review	Approved	Label Letter
Jul 21, 2017	Supplement 9Labeling · Standard review	Approved	Label Letter
Feb 25, 2011	Supplement 8Labeling · Standard review	Approved	Label Letter
Dec 2, 2003	Supplement 3Labeling · Standard review	Approved	Letter Label
Dec 2, 2003	Supplement 5Labeling · Standard review	Approved	Letter Label
Jun 17, 1999	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 17, 1999	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 13, 1997	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 20600
Drugs@FDA: Overview at FDA
Company: Chartwell 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