NDA 20868, held by Pfizer. Metronidazole.
As of Nov 14, 2026, NDA 20868 (Flagyl Er), held by Pfizer, was first approved by FDA on Nov 26, 1997, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 26, 1997 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Flagyl Er750MG · tablet, extended release;oral | Metronidazole | DiscontinuedReference drug |
| Jul 8, 2024 | Supplement 17Labeling · Standard review | Approved | |
| Oct 6, 2023 | Supplement 15Labeling · Standard review | Approved | |
| Dec 15, 2021 | Supplement 14Labeling · Standard review | Approved | |
| Mar 5, 2021 | Supplement 13Labeling · Standard review | Approved | |
| Apr 3, 2018 | Supplement 12Labeling · Standard review | Approved | |
| Jul 13, 2015 | Supplement 11Labeling · Standard review | Approved | |
| Apr 14, 2015 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Aug 16, 2013 | Supplement 9Labeling | Approved | |
| Aug 19, 2010 | Supplement 8Labeling | Approved | |
| Mar 17, 2004 | Supplement 6Labeling · Standard review | Approved | |
| Apr 23, 2003 | Supplement 5Labeling · Standard review | Approved | |
| Nov 4, 1998 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Oct 8, 1998 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jul 24, 1998 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Feb 20, 1998 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Nov 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
