Differin

NDA 22502, held by Galderma Labs LP. Adapalene.

As of Nov 13, 2026, NDA 22502 (Differin), held by Galderma Labs LP, was first approved by FDA on Mar 17, 2010, with 5 approved supplements and 0 published complete response letters.

First approved: Mar 17, 2010
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Mar 17, 2010	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Differin0.1% · lotion;topical	Adapalene	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


Apr 19, 2023	Supplement 10Labeling · Standard review	Approved	Label Letter
Aug 24, 2022	Supplement 8Labeling · Standard review	Approved	Label
Sep 30, 2014	Supplement 5Manufacturing · Standard review	Approved	None posted
May 29, 2014	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 19, 2013	Supplement 3Labeling · Standard review	Approved	Label Letter
Mar 17, 2010	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22502
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