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As of Nov 13, 2026, NDA 19049 (Retin-A), held by Bausch, was first approved by FDA on Sep 16, 1988, with 14 approved supplements and 0 published complete response letters.
First approved: Sep 16, 1988
Review: Standard
Supplements approved: 14
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
INDICATIONS AND USAGE Tretinoin 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.
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
