Epiduo

NDA 22320, held by Galderma Labs LP. Adapalene; Benzoyl Peroxide.

As of Nov 13, 2026, NDA 22320 (Epiduo), held by Galderma Labs LP, was first approved by FDA on Dec 8, 2008, with 6 approved supplements and 0 published complete response letters.

First approved: Dec 8, 2008
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Feb 1, 2013	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Dec 8, 2008	Original applicationNew combination · Standard review	Approved	Summary Review Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Epiduo0.1%;2.5% · gel;topical	Adapalene; Benzoyl Peroxide	DiscontinuedReference drug

All 7 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 1, 2014	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 1, 2014	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 15, 2013	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 1, 2013	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Dec 14, 2011	Supplement 2Labeling	Approved	Review Letter Label
Feb 18, 2011	Supplement 1Labeling	Approved	Letter Label
Dec 8, 2008	Original applicationNew combination · Standard review	Approved	Summary Review Review Label Letter

Identifiers

Application: NDA 22320
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