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Active ingredient

Azelate

13 finished FDA listings contain Azelate as their only active ingredient; 7 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
AZELAIC ACID
Dosage forms
Aerosol, Foam, Cream, Gel
Routes
Cutaneous, Topical
Manufacturers / labelers
11
Strengths listed
.12 g/g · .14 g/g · .15 g/g · .2 g/g · 10 g/100g · 14 g/100g
Brand names in FDA listings
10% Azelaic Acid, 14% Azelaic Acid, 14% Azelaic Acid Acne, Azelaic Acid Gel, Azelex, Bloomellee 12%Gel Azelaic Acid Acne, Bloomellee 14%Gel Azelaic Acid Cream, Finacea Foam

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 618278

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 020428ALMIRALL1995-09-131
NDA 021470LEO PHARMA AS2002-12-241
NDA 207071LEO PHARMA AS2015-07-291
ANDA 204637GLENMARK SPECLT2018-11-191
ANDA 208724ENCUBE2018-11-192
ANDA 208011ACTAVIS LABS UT INC2018-11-191
ANDA 210549SUN PHARMA CANADA2019-08-231

Official labeling on DailyMed

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.