Treats inflammatory papules and pustules of rosacea. NDA 20531, held by Galderma Labs LP. Metronidazole.
As of Nov 13, 2026, NDA 20531 (Metrocream), held by Galderma Labs LP, was first approved by FDA on Sep 20, 1995, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE: Metronidazole Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 20, 1995 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Metrocream0.75% · cream;topical | Metronidazole | RxReference drug |
| Aug 30, 2002 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Sep 20, 1995 | Original applicationNew dosage form · Standard review | 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
