Metronidazole

NDA 18517, held by Ivax Sub Teva Pharms. Metronidazole.

As of Nov 13, 2026, NDA 18517 (Metronidazole), held by Ivax Sub Teva Pharms, was first approved by FDA on Oct 30, 1981, with 25 approved supplements and 0 published complete response letters.

First approved: Oct 30, 1981
Supplements approved: 25
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 26 submissions below

Date	Submission	Status	Documents
Oct 30, 1981	Original application	Approved	None posted

Products

2 strengths and forms


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

All 26 submissions, including labeling and manufacturing supplements


Dec 14, 2004	Supplement 37Labeling	Approved	None posted
Apr 19, 2004	Supplement 36Labeling	Approved	None posted
Jul 29, 2002	Supplement 34Manufacturing	Approved	None posted
Sep 12, 2001	Supplement 32Manufacturing	Approved	None posted
Jan 28, 2000	Supplement 31Manufacturing	Approved	None posted
Dec 23, 1999	Supplement 30Manufacturing	Approved	None posted
Feb 6, 1998	Supplement 29Manufacturing	Approved	None posted
Oct 1, 1997	Supplement 24Labeling	Approved	None posted
Dec 26, 1996	Supplement 28Manufacturing	Approved	None posted
Dec 26, 1996	Supplement 27Manufacturing	Approved	None posted
Apr 29, 1996	Supplement 21Manufacturing	Approved	None posted
Jul 31, 1995	Supplement 20Manufacturing	Approved	None posted
Jan 30, 1995	Supplement 19Manufacturing	Approved	None posted
Nov 30, 1994	Supplement 18Manufacturing	Approved	None posted
Jul 16, 1993	Supplement 17Labeling	Approved	None posted
Nov 3, 1992	Supplement 15Labeling	Approved	None posted
Nov 3, 1992	Supplement 14Manufacturing	Approved	None posted
Feb 26, 1992	Supplement 10Labeling	Approved	None posted
Dec 9, 1991	Supplement 13Manufacturing	Approved	None posted
Dec 9, 1991	Supplement 12Manufacturing	Approved	None posted
Dec 9, 1991	Supplement 11Labeling	Approved	None posted
May 10, 1985	Supplement 9Manufacturing	Approved	None posted
May 10, 1985	Supplement 8Manufacturing	Approved	None posted
May 10, 1985	Supplement 7Manufacturing	Approved	None posted
May 10, 1985	Supplement 6Manufacturing	Approved	None posted
Oct 30, 1981	Original application	Approved	None posted

Identifiers

Application: NDA 18517
Drugs@FDA: Overview at FDA
Company: IVAX Pharmaceuticals

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