Magnevist

NDA 21037, held by Bayer Hlthcare. Gadopentetate Dimeglumine.

As of Nov 15, 2026, NDA 21037 (Magnevist), held by Bayer Hlthcare, was first approved by FDA on Mar 10, 2000, with 18 approved supplements and 0 published complete response letters.

First approved: Mar 10, 2000
Review: Standard
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Mar 10, 2000	Original applicationNew dosage form · Standard review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Magnevist469.01MG/ML · injectable;injection	Gadopentetate Dimeglumine	DiscontinuedReference drug

All 19 submissions, including labeling and manufacturing supplements


Jul 25, 2018	Supplement 38Labeling · Standard review	Approved	Label Medication Guide Letter
Jul 25, 2018	Supplement 37Labeling · Standard review	Approved	Label Letter
Apr 26, 2018	Supplement 36Labeling · Standard review	Approved	Letter Label
Jul 31, 2015	Supplement 31Labeling · Standard review	Approved	Label Letter
Jun 11, 2014	Supplement 30Labeling · Standard review	Approved	Label Letter
Oct 17, 2013	Supplement 29Labeling · Standard review	Approved	Label Letter
Mar 29, 2012	Supplement 25Labeling · Standard review	Approved	Letter Label
Dec 20, 2010	Supplement 23Labeling	Approved	Letter Label
Aug 19, 2010	Supplement 11Labeling · Standard review	Approved	Label Letter
May 22, 2009	Supplement 19Manufacturing	Approved	Letter Label
Sep 4, 2007	Supplement 18Labeling · Standard review	Approved	Letter Label
Sep 13, 2006	Supplement 14Labeling · Standard review	Approved	Letter
Sep 17, 2004	Supplement 10Labeling · Standard review	Approved	Letter
Oct 29, 2002	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 20, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 5, 2001	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 6, 2001	Supplement 2Manufacturing · Standard review	Approved	None posted
Oct 24, 2000	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 10, 2000	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 21037
Drugs@FDA: Overview at FDA
Company: Bayer Healthcare

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