Azelaic Acid

Product manufactured by Alvogen, Inc.

Application Nr Approved Date Route Status External Links
NDA021470 2002-12-24 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Azelaic Acid Gel, 15% Is Indicated For Topical Treatment Of The Inflammatory Papules And Pustules Of Mild To Moderate Rosacea. Although Some Reduction Of Erythema Which Was Present In Patients With Papules And Pustules Of Rosacea Occurred In Clinical Studies, Efficacy For Treatment Of Erythema In Rosacea In The Absence Of Papules And Pustules Has Not Been Evaluated. Azelaic Acid Gel, 15% Is Indicated For Topical Treatment Of The Inflammatory Papules And Pustules Of Mild To Moderate Rosacea. Efficacy For Treatment Of Erythema In Rosacea In The Absence Of Papules And Pustules Has Not Been Evaluated. (1)

All Formulated Excipients (6 Total)

Name Structure Kind Function Status
1. Edetate Disodium Anhydrous EDETATE DISODIUM ANHYDROUS Molecular
2. Lecithin LECITHIN Unresolved
3. Medium-Chain Triglycerides MEDIUM-CHAIN TRIGLYCERIDES Unresolved
4. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
5. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Water WATER Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Azelaic Acid

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