Treats inflammatory lesions of rosacea. NDA 21789, held by Galderma Labs LP. Metronidazole.
As of Nov 14, 2026, NDA 21789 (Metrogel), held by Galderma Labs LP, was first approved by FDA on Jun 30, 2005, with 9 approved supplements and 0 published complete response letters.
Metronidazole Gel, 1% is indicated for the topical treatment of inflammatory lesions of rosacea.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 30, 2005 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Metrogel1% · gel;topical | Metronidazole | RxReference drug |
| Nov 22, 2023 | Supplement 13Labeling · Standard review | Approved | |
| Mar 16, 2022 | Supplement 10Labeling · Standard review | Approved | |
| Mar 16, 2022 | Supplement 9Labeling · Standard review | Approved | |
| Jan 12, 2015 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Sep 4, 2014 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Oct 19, 2011 | Supplement 4Labeling | Approved | |
| Mar 5, 2010 | Supplement 3Labeling · Standard review | Approved | |
| Aug 29, 2006 | Supplement 2Manufacturing | Approved | None posted |
| Nov 14, 2005 | Supplement 1Labeling · Standard review | Approved | |
| Jun 30, 2005 | 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
