Treats inflammatory papules and pustules of mild to moderate rosacea. NDA 21470, held by Leo Pharma As. Azelaic Acid.
As of Nov 14, 2026, NDA 21470 (Finacea), held by Leo Pharma As, was first approved by FDA on Dec 24, 2002, with 11 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.
| May 5, 2005 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Dec 24, 2002 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Finacea15% · gel;topical | Azelaic Acid | RxReference drug |
| Nov 1, 2021 | Supplement 17Labeling · Standard review | Approved | |
| Nov 27, 2020 | Supplement 15Labeling · Standard review | Approved | |
| Nov 27, 2020 | Supplement 16Labeling · Standard review | Approved | |
| Aug 5, 2016 | Supplement 13Labeling · Standard review | Approved | |
| Dec 28, 2015 | Supplement 12Labeling · Standard review | Approved | |
| Apr 3, 2015 | Supplement 10Labeling · Standard review | Approved | |
| Feb 3, 2015 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Oct 23, 2014 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Dec 18, 2012 | Supplement 7Labeling | Approved | |
| Oct 25, 2010 | Supplement 5Labeling · Standard review | Approved | |
| May 5, 2005 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Dec 24, 2002 | Original applicationNew dosage form · Standard review | 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
