Treats acne. NDA 20380, held by Galderma Labs LP. Adapalene.
As of Nov 13, 2026, NDA 20380 (Differin), held by Galderma Labs LP, was first approved by FDA on May 31, 1996, with 5 approved supplements and 0 published complete response letters.
Use For the treatment of acne
| Jul 8, 2016 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| May 31, 1996 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Differin0.1% · gel;topical | Adapalene | OTCReference drug |
| Jun 14, 2022 | Supplement 21Labeling · Standard review | Approved | |
| Mar 23, 2018 | Supplement 13Labeling · Standard review | Approved | |
| May 19, 2017 | Supplement 11Labeling · Standard review | Approved | |
| Jul 8, 2016 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Sep 5, 2007 | Supplement 4Manufacturing | Approved | None posted |
| May 31, 1996 | Original applicationNew dosage form · Standard review | Approved | None posted |
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
