Treats inflammatory lesions and erythema of rosacea. NDA 20743, held by Bausch. Metronidazole.
As of Nov 13, 2026, NDA 20743 (Noritate), held by Bausch, was first approved by FDA on Sep 26, 1997, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Noritate is indicated for the topical treatment of inflammatory lesions and erythema of rosacea.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 26, 1997 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Noritate1% · cream;topical | Metronidazole | RxReference drug |
| Dec 5, 2014 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jul 4, 2004 | Supplement 6Manufacturing · Standard review | Approved | |
| Apr 4, 2003 | Supplement 2Labeling · Standard review | Approved | |
| Sep 26, 1997 | 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
