Differin

Treats acne vulgaris. NDA 20748, held by Galderma Labs LP. Adapalene.

As of Nov 13, 2026, NDA 20748 (Differin), held by Galderma Labs LP, was first approved by FDA on May 26, 2000, with 3 approved supplements and 0 published complete response letters.

First approved: May 26, 2000
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Adapalene Cream, 0.1% is indicated for the topical treatment of acne vulgaris.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
May 26, 2000	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Differin0.1% · cream;topical	Adapalene	RxReference drug

All 4 submissions, including labeling and manufacturing supplements


Aug 1, 2014	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 8, 2013	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 25, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
May 26, 2000	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 20748
Drugs@FDA: Overview at FDA
Company: Galderma Laboratories

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