Metronidazole

NDA 18818, held by Mutual Pharm. Metronidazole.

As of Nov 13, 2026, NDA 18818 (Metronidazole), held by Mutual Pharm, was first approved by FDA on Feb 16, 1983, with 21 approved supplements and 0 published complete response letters.

First approved: Feb 16, 1983
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
Feb 16, 1983	Original application	Approved	None posted

Products

2 strengths and forms


Metronidazole250MG · tablet;oral	Metronidazole	Discontinued
Metronidazole500MG · tablet;oral	Metronidazole	Discontinued

All 22 submissions, including labeling and manufacturing supplements


Dec 1, 1998	Supplement 32Manufacturing	Approved	None posted
May 21, 1997	Supplement 31Labeling	Approved	None posted
Dec 23, 1994	Supplement 30Manufacturing	Approved	None posted
Oct 11, 1994	Supplement 29Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 28Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 26Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 24Manufacturing	Approved	None posted
Apr 3, 1992	Supplement 23Manufacturing	Approved	None posted
Jul 18, 1991	Supplement 22Labeling	Approved	None posted
Jun 7, 1991	Supplement 21Labeling	Approved	None posted
May 8, 1991	Supplement 20Manufacturing	Approved	None posted
May 8, 1991	Supplement 19Manufacturing	Approved	None posted
Apr 1, 1991	Supplement 18Manufacturing	Approved	None posted
Apr 1, 1991	Supplement 17Manufacturing	Approved	None posted
Nov 29, 1988	Supplement 16Labeling	Approved	None posted
Apr 3, 1987	Supplement 13Manufacturing	Approved	None posted
Jun 13, 1986	Supplement 10Manufacturing	Approved	None posted
Jun 13, 1986	Supplement 9Manufacturing	Approved	None posted
Jun 13, 1986	Supplement 8Manufacturing	Approved	None posted
Jul 31, 1985	Supplement 6Manufacturing	Approved	None posted
Apr 2, 1985	Supplement 2Manufacturing	Approved	None posted
Feb 16, 1983	Original application	Approved	None posted

Identifiers

Application: NDA 18818
Drugs@FDA: Overview at FDA
Company: Mutual Pharmaceutical Company

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