Metro I.V.

NDA 18674, held by B Braun. Metronidazole.

As of Nov 13, 2026, NDA 18674 (Metro I.V.), held by B Braun, was first approved by FDA on Aug 31, 1982, with 5 approved supplements and 0 published complete response letters.

First approved: Aug 31, 1982
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Aug 31, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Metro I.V.500MG/100ML · injectable;injection	Metronidazole	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Jun 22, 1990	Supplement 10Labeling	Approved	None posted
Jan 25, 1989	Supplement 9Labeling	Approved	None posted
Jul 8, 1988	Supplement 8Labeling	Approved	None posted
Feb 22, 1985	Supplement 6Manufacturing	Approved	None posted
Feb 22, 1985	Supplement 7Manufacturing	Approved	None posted
Aug 31, 1982	Original application	Approved	None posted

Identifiers

Application: NDA 18674
Drugs@FDA: Overview at FDA
Company: B. Braun Medical

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