Differin

NDA 20338, held by Galderma Labs LP. Adapalene.

As of Nov 14, 2026, NDA 20338 (Differin), held by Galderma Labs LP, was first approved by FDA on May 31, 1996, with 3 approved supplements and 0 published complete response letters.

First approved: May 31, 1996
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
May 31, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Differin0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;topical	Adapalene	DiscontinuedReference drug

All 4 submissions, including labeling and manufacturing supplements


Apr 8, 2002	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 10, 1999	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 12, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
May 31, 1996	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 20338
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