Metro I.V. In Plastic Container

NDA 18900, held by B Braun. Metronidazole.

As of Nov 13, 2026, NDA 18900 (Metro I.V. In Plastic Container), held by B Braun, was first approved by FDA on Sep 29, 1983, with 25 approved supplements and 0 published complete response letters.

First approved: Sep 29, 1983
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
Sep 29, 1983	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Metro I.V. In Plastic Container500MG/100ML · injectable;injection	Metronidazole	DiscontinuedReference drug

All 26 submissions, including labeling and manufacturing supplements


Apr 23, 2026	Supplement 46Labeling · Standard review	Approved	Letter Label
Mar 14, 2025	Supplement 45Labeling · Standard review	Approved	Letter Label
Jul 8, 2024	Supplement 43Labeling · Standard review	Approved	Letter Label
Dec 15, 2021	Supplement 41Labeling · Standard review	Approved	Letter Label
Apr 29, 2021	Supplement 38Labeling · Standard review	Approved	Label Letter
Mar 5, 2021	Supplement 39Labeling · Standard review	Approved	Letter Label
Apr 11, 2018	Supplement 35Labeling · Standard review	Approved	Letter Label
Dec 8, 2015	Supplement 31Labeling · Standard review	Approved	Letter Label
Jul 13, 2015	Supplement 32Labeling · Standard review	Approved	Label Letter
Jun 23, 2014	Supplement 28Manufacturing	Approved	None posted
Mar 25, 2014	Supplement 30Manufacturing	Approved	None posted
Aug 20, 2008	Supplement 27Labeling	Approved	None posted
Jul 21, 2007	Supplement 25Labeling	Approved	None posted
Feb 20, 2004	Supplement 23Labeling	Approved	None posted
Jul 8, 1997	Supplement 21Manufacturing	Approved	None posted
May 12, 1997	Supplement 18Manufacturing	Approved	None posted
Mar 22, 1996	Supplement 16Manufacturing	Approved	None posted
Mar 17, 1993	Supplement 14Labeling	Approved	None posted
Nov 6, 1991	Supplement 13Manufacturing	Approved	None posted
Sep 30, 1991	Supplement 12Manufacturing	Approved	None posted
Jun 12, 1991	Supplement 11Labeling	Approved	None posted
Sep 1, 1989	Supplement 8Manufacturing	Approved	None posted
Jan 25, 1989	Supplement 10Labeling	Approved	None posted
Jun 17, 1988	Supplement 7Labeling	Approved	None posted
Mar 11, 1985	Supplement 6Manufacturing	Approved	None posted
Sep 29, 1983	Original application	Approved	None posted

Identifiers

Application: NDA 18900
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