Treats inflammatory papules and pustules of mild to moderate rosacea. ANDA 204637, held by Glenmark Speclt. Azelaic Acid.
As of Nov 15, 2026, ANDA 204637 (Azelaic Acid), held by Glenmark Speclt, 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 |
| Product | Active ingredient | Marketing |
|---|---|---|
| Azelaic Acid15% · gel;topical | Azelaic Acid | Rx |
| Jul 1, 2022 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jul 1, 2022 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 19, 2018 | Original application | Approved |
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
