Treats inflammatory papules and pustules of mild to moderate rosacea. ANDA 210549, held by Sun Pharma Canada. Azelaic Acid.
As of Nov 15, 2026, ANDA 210549 (Azelaic Acid), held by Sun Pharma Canada, was first approved by FDA on Aug 23, 2019, 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 23, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Azelaic Acid15% · gel;topical | Azelaic Acid | Rx |
| Oct 31, 2022 | Supplement 4Labeling · Standard review | Approved | None posted |
| Oct 31, 2022 | Supplement 5Labeling · Standard review | Approved | None posted |
| Aug 23, 2019 | 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
