Treats inflammatory papules and pustules of mild to moderate rosacea. ANDA 208724, held by Encube. Azelaic Acid.
As of Nov 15, 2026, ANDA 208724 (Azelaic Acid), held by Encube, was first approved by FDA on Nov 19, 2018, with 2 approved supplements and 0 published complete response letters.
Azelaic Acid Gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Limitations of Use 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 19, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Azelaic Acid15% · gel;topical | Azelaic Acid | Rx |
| Jul 1, 2022 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jul 1, 2022 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 19, 2018 | Original application | Approved | None posted |
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
