Retin-A

Treats acne vulgaris. NDA 17579, held by Valeant Intl. Tretinoin.

As of Nov 14, 2026, NDA 17579 (Retin-A), held by Valeant Intl, was first approved by FDA on Apr 18, 1975, with 21 approved supplements and 0 published complete response letters.

First approved: Apr 18, 1975
Review: Standard
Supplements approved: 21
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE RETIN-A is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Apr 18, 1975	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Retin-A0.025% · gel;topical	Tretinoin	RxReference drug

All 22 submissions, including labeling and manufacturing supplements


May 14, 2013	Supplement 32Manufacturing · Standard review	Approved	None posted
Jun 10, 2002	Supplement 23Labeling · Standard review	Approved	Letter Label
Jun 10, 2002	Supplement 20Labeling · Standard review	Approved	Letter Label
Jun 10, 2002	Supplement 18Labeling · Standard review	Approved	Letter Label
Mar 20, 2001	Supplement 24Manufacturing · Standard review	Approved	None posted
Jan 25, 1999	Supplement 22Manufacturing · Standard review	Approved	None posted
Jul 23, 1998	Supplement 21Manufacturing · Standard review	Approved	None posted
Jan 31, 1992	Supplement 16Manufacturing · Standard review	Approved	None posted
Aug 28, 1990	Supplement 14Labeling	Approved	None posted
Aug 28, 1990	Supplement 13Labeling	Approved	None posted
Jul 3, 1990	Supplement 15Manufacturing · Standard review	Approved	None posted
Dec 1, 1989	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 23, 1986	Supplement 9Manufacturing · Standard review	Approved	None posted
Jun 11, 1985	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 30, 1982	Supplement 8Labeling	Approved	None posted
Jul 29, 1981	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 28, 1980	Supplement 5Labeling	Approved	None posted
Oct 23, 1979	Supplement 4Manufacturing · Standard review	Approved	None posted
Dec 1, 1978	Supplement 3Labeling	Approved	None posted
Jun 14, 1977	Supplement 2Manufacturing · Standard review	Approved	None posted
Jan 4, 1977	Supplement 1Labeling	Approved	None posted
Apr 18, 1975	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 17579
Drugs@FDA: Overview at FDA
Company: Valeant Intl

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