Flagyl I.V., Flagyl I.V. Rtu In Plastic Container

NDA 18353, held by Pfizer. Metronidazole Hydrochloride, Metronidazole.

As of Nov 13, 2026, NDA 18353 (Flagyl I.V., Flagyl I.V. Rtu In Plastic Container), held by Pfizer, was first approved by FDA on Nov 28, 1980, with 24 approved supplements and 0 published complete response letters.

First approved: Nov 28, 1980
Review: Priority
Supplements approved: 24
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Feb 17, 1988	Supplement 15Efficacy (new indication or use)	Approved	None posted
Nov 28, 1980	Original applicationNew dosage form · Priority review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Flagyl I.V.EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Metronidazole Hydrochloride	Discontinued
Flagyl I.V. Rtu In Plastic Container500MG/100ML · injectable;injection	Metronidazole	Discontinued

All 25 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 13, 2015	Supplement 27Labeling · Standard review	Approved	Label Letter
Aug 16, 2013	Supplement 26Labeling	Approved	Label Letter
Mar 5, 1993	Supplement 25Manufacturing · Priority review	Approved	None posted
Nov 30, 1992	Supplement 24Labeling	Approved	None posted
Apr 13, 1989	Supplement 23Labeling	Approved	None posted
Feb 17, 1988	Supplement 22Labeling	Approved	None posted
Feb 17, 1988	Supplement 16Labeling	Approved	None posted
Feb 17, 1988	Supplement 15Efficacy (new indication or use)	Approved	None posted
Feb 17, 1988	Supplement 14Labeling	Approved	None posted
Oct 29, 1987	Supplement 13Manufacturing · Priority review	Approved	None posted
Aug 21, 1987	Supplement 11Manufacturing · Priority review	Approved	None posted
Sep 9, 1986	Supplement 21Manufacturing · Priority review	Approved	None posted
Sep 2, 1986	Supplement 20Labeling	Approved	None posted
Jun 20, 1986	Supplement 17Manufacturing · Priority review	Approved	None posted
Apr 24, 1986	Supplement 18Manufacturing · Priority review	Approved	None posted
Dec 20, 1984	Supplement 2Labeling	Approved	None posted
Dec 14, 1983	Supplement 10Labeling	Approved	None posted
Dec 2, 1982	Supplement 9Manufacturing · Priority review	Approved	None posted
Sep 15, 1982	Supplement 8Manufacturing · Priority review	Approved	None posted
Jun 30, 1982	Supplement 7Labeling	Approved	None posted
Jan 11, 1982	Supplement 6Manufacturing · Priority review	Approved	None posted
Nov 25, 1981	Supplement 3Manufacturing · Priority review	Approved	None posted
Nov 2, 1981	Supplement 5Manufacturing · Priority review	Approved	None posted
May 29, 1981	Supplement 1Manufacturing · Priority review	Approved	None posted
Nov 28, 1980	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 18353
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