Flagyl

NDA 12623, held by Pfizer. Metronidazole.

As of Nov 13, 2026, NDA 12623 (Flagyl), held by Pfizer, was first approved by FDA on Jul 18, 1963, with 46 approved supplements and 0 published complete response letters.

First approved: Jul 18, 1963
Review: Priority
Supplements approved: 46
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 47 submissions below


Feb 10, 1988	Supplement 41Efficacy (new indication or use)	Approved	None posted
Jul 18, 1963	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms


Flagyl250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Metronidazole	DiscontinuedReference drug
Flagyl500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Metronidazole	DiscontinuedReference drug

All 47 submissions, including labeling and manufacturing supplements


Jul 8, 2024	Supplement 72Labeling · Standard review	Approved	Letter Label
Oct 6, 2023	Supplement 70Labeling · Standard review	Approved	Letter Label
Dec 15, 2021	Supplement 69Labeling · Standard review	Approved	Letter Label
Mar 5, 2021	Supplement 68Labeling · Standard review	Approved	Letter Label
Apr 3, 2018	Supplement 67Labeling · Standard review	Approved	Letter Label
Jul 13, 2015	Supplement 66Labeling · Standard review	Approved	Label Letter
Aug 16, 2013	Supplement 65Labeling · Standard review	Approved	Label Letter
Aug 19, 2010	Supplement 61Labeling	Approved	Letter Label
Mar 17, 2004	Supplement 59Labeling · Standard review	Approved	Label Letter
Apr 23, 2003	Supplement 58Labeling · Standard review	Approved	Letter Label
May 7, 1996	Supplement 53Labeling	Approved	None posted
May 7, 1996	Supplement 51Labeling	Approved	None posted
May 7, 1996	Supplement 49Labeling	Approved	None posted
May 7, 1996	Supplement 48Labeling	Approved	None posted
Feb 16, 1994	Supplement 56Manufacturing · Priority review	Approved	None posted
Jun 23, 1992	Supplement 54Manufacturing · Priority review	Approved	None posted
Jul 30, 1990	Supplement 52Manufacturing · Priority review	Approved	None posted
Apr 13, 1989	Supplement 50Labeling	Approved	None posted
Feb 3, 1989	Supplement 47Labeling	Approved	None posted
Feb 10, 1988	Supplement 41Efficacy (new indication or use)	Approved	None posted
Dec 28, 1987	Supplement 45Labeling	Approved	None posted
Nov 3, 1987	Supplement 40Labeling	Approved	None posted
Aug 21, 1987	Supplement 38Labeling	Approved	None posted
Jun 18, 1987	Supplement 46Manufacturing · Priority review	Approved	None posted
Jul 22, 1986	Supplement 44Labeling	Approved	None posted
Mar 30, 1984	Supplement 37Labeling	Approved	None posted
Oct 18, 1983	Supplement 35Labeling	Approved	None posted
Oct 18, 1983	Supplement 34Labeling	Approved	None posted
Jun 2, 1983	Supplement 36Manufacturing · Priority review	Approved	None posted
May 5, 1982	Supplement 33Manufacturing · Priority review	Approved	None posted
Feb 4, 1982	Supplement 31Manufacturing · Priority review	Approved	None posted
Aug 13, 1981	Supplement 32Manufacturing · Priority review	Approved	None posted
Aug 4, 1981	Supplement 30Manufacturing · Priority review	Approved	None posted
Dec 12, 1980	Supplement 29Manufacturing · Priority review	Approved	None posted
Dec 8, 1980	Supplement 27Labeling	Approved	None posted
Feb 27, 1980	Supplement 26Manufacturing · Priority review	Approved	None posted
Jan 9, 1980	Supplement 28Manufacturing · Priority review	Approved	None posted
Jan 2, 1980	Supplement 25Manufacturing · Priority review	Approved	None posted
Jul 26, 1979	Supplement 24Labeling	Approved	None posted
Apr 19, 1979	Supplement 22Manufacturing · Priority review	Approved	None posted
Mar 2, 1979	Supplement 23Labeling	Approved	None posted
Aug 22, 1977	Supplement 19Labeling	Approved	None posted
Oct 5, 1976	Supplement 18Manufacturing · Priority review	Approved	None posted
Nov 5, 1975	Supplement 15Labeling	Approved	None posted
May 14, 1974	Supplement 13Labeling	Approved	None posted
May 14, 1974	Supplement 12	Approved	None posted
Jul 18, 1963	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 12623
Drugs@FDA: Overview at FDA
Company: Pfizer

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