NDA 18764, held by Watson Labs. Metronidazole.
As of Nov 13, 2026, NDA 18764 (Metronidazole), held by Watson Labs, was first approved by FDA on Sep 17, 1982, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 17, 1982 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Metronidazole250MG · tablet;oral | Metronidazole | Discontinued |
| Metronidazole500MG · tablet;oral | Metronidazole | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 15, 2021 | Supplement 44Labeling · Standard review | Approved | |
| Mar 5, 2021 | Supplement 43Labeling · Standard review | Approved | |
| Oct 17, 2018 | Supplement 42Labeling · Standard review | Approved | |
| Jan 24, 2005 | Supplement 31Labeling | Approved | None posted |
| Oct 1, 2001 | Supplement 29Manufacturing | Approved | None posted |
| Apr 25, 2001 | Supplement 28Manufacturing | Approved | None posted |
| Jun 8, 1998 | Supplement 25Manufacturing | Approved | None posted |
| Aug 8, 1997 | Supplement 24Labeling | Approved | None posted |
| Aug 22, 1991 | Supplement 21Labeling | Approved | None posted |
| Aug 7, 1991 | Supplement 19Manufacturing | Approved | None posted |
| Jan 28, 1991 | Supplement 20Manufacturing | Approved | None posted |
| Jul 22, 1988 | Supplement 18Labeling | Approved | None posted |
| Jun 5, 1985 | Supplement 7Manufacturing | Approved | None posted |
| Jun 5, 1985 | Supplement 6Manufacturing | Approved | None posted |
| Sep 17, 1982 | Original application | 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
