Metronidazole

NDA 18889, held by Abbott. Metronidazole.

As of Nov 13, 2026, NDA 18889 (Metronidazole), held by Abbott, was first approved by FDA on Nov 18, 1983, with 6 approved supplements and 0 published complete response letters.

First approved: Nov 18, 1983
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Nov 18, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Metronidazole500MG/100ML · injectable;injection	Metronidazole	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Sep 20, 1996	Supplement 11Manufacturing	Approved	None posted
Jun 23, 1993	Supplement 10Labeling	Approved	None posted
Nov 20, 1989	Supplement 9Labeling	Approved	None posted
Aug 17, 1989	Supplement 8Labeling	Approved	None posted
Apr 3, 1985	Supplement 4Manufacturing	Approved	None posted
Jul 24, 1984	Supplement 3Manufacturing	Approved	None posted
Nov 18, 1983	Original application	Approved	None posted

Identifiers

Application: NDA 18889
Drugs@FDA: Overview at FDA
Company: Abbott

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