Metronidazole

NDA 18930, held by Chartwell Molecules. Metronidazole.

As of Nov 13, 2026, NDA 18930 (Metronidazole), held by Chartwell Molecules, was first approved by FDA on Aug 18, 1983, with 11 approved supplements and 0 published complete response letters.

First approved: Aug 18, 1983
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

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

Products

1 strengths and forms

Product	Active ingredient	Marketing
Metronidazole500MG · tablet;oral	Metronidazole	Discontinued

All 12 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 8, 2024	Supplement 16Labeling · Standard review	Approved	Label
Dec 15, 2021	Supplement 15Labeling · Standard review	Approved	Letter Label
Mar 5, 2021	Supplement 14Labeling · Standard review	Approved	Letter Label
Apr 27, 2020	Supplement 13Labeling · Standard review	Approved	Letter Label
Apr 16, 1992	Supplement 12Labeling	Approved	None posted
Nov 3, 1988	Supplement 11Labeling	Approved	None posted
Jun 16, 1988	Supplement 10Labeling	Approved	None posted
Jun 3, 1986	Supplement 7Manufacturing	Approved	None posted
Jun 3, 1986	Supplement 6Manufacturing	Approved	None posted
Jun 6, 1985	Supplement 4Manufacturing	Approved	None posted
Apr 8, 1985	Supplement 5Manufacturing	Approved	None posted
Aug 18, 1983	Original application	Approved	None posted

Identifiers

Application: NDA 18930
Drugs@FDA: Overview at FDA
Company: Chartwell Molecules

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