Treats acne vulgaris. NDA 21753, held by Galderma Labs LP. Adapalene.
As of Nov 14, 2026, NDA 21753 (Differin), held by Galderma Labs LP, was first approved by FDA on Jun 19, 2007, with 6 approved supplements and 0 published complete response letters.
Adapalene Gel is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 19, 2007 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Differin0.3% · gel;topical | Adapalene | RxReference drug |
| Dec 27, 2023 | Supplement 14Labeling · Standard review | Approved | |
| Dec 27, 2023 | Supplement 18Labeling · Standard review | Approved | |
| Aug 25, 2022 | Supplement 11Labeling · Standard review | Approved | |
| Jun 13, 2014 | Supplement 7Manufacturing · Standard review | Approved | |
| Feb 27, 2012 | Supplement 4Manufacturing | Approved | |
| Sep 1, 2010 | Supplement 2Labeling | Approved | |
| Jun 19, 2007 | 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
