Azelex

Treats mild-to-moderate inflammatory acne vulgaris. NDA 20428, held by Almirall. Azelaic Acid.

As of Nov 13, 2026, NDA 20428 (Azelex), held by Almirall, was first approved by FDA on Sep 13, 1995, with 16 approved supplements and 0 published complete response letters.

First approved: Sep 13, 1995
Review: Standard
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE AZELEX cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Sep 13, 1995	Original applicationNew molecular entity · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Azelex20% · cream;topical	Azelaic Acid	RxReference drug

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 20, 2024	Supplement 27Manufacturing · Standard review	Approved	Label
Jan 6, 2020	Supplement 22Labeling · Standard review	Approved	Letter
Jun 10, 2003	Supplement 16Labeling · Standard review	Approved	Letter Label
Feb 19, 2002	Supplement 15Manufacturing · Standard review	Approved	None posted
Apr 27, 2001	Supplement 13Labeling · Standard review	Approved	Label
Apr 5, 2000	Supplement 12Manufacturing · Standard review	Approved	None posted
Nov 10, 1999	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 10, 1999	Supplement 11Manufacturing · Standard review	Approved	None posted
Sep 4, 1998	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 4, 1998	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 23, 1997	Supplement 7Manufacturing · Standard review	Approved	Review
Jun 29, 1997	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 27, 1996	Supplement 4Manufacturing · Standard review	Approved	None posted
May 17, 1996	Supplement 1Manufacturing · Standard review	Approved	Review
May 17, 1996	Supplement 2Manufacturing · Standard review	Approved	None posted
May 17, 1996	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 13, 1995	Original applicationNew molecular entity · Standard review	Approved	Review

Identifiers

Application: NDA 20428
Drugs@FDA: Overview at FDA
Company: Almirall

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