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FDA NDA · NDA021037

MAGNEVIST

Sponsor: BAYER HLTHCARE

APPLICATION
NDA021037
TYPE
NDA
ORIGINAL APPROVAL
2000-03-10
LATEST ACTION
2018-07-25
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

MAGNEVIST · ReferenceDiscontinued
GADOPENTETATE DIMEGLUMINE 469.01MG/ML · INJECTABLE · INJECTION

Approval history

2018-07-25Labeling · Supplement 37 · standard — Label ↗AP
2018-07-25Labeling · Supplement 38 · standard — Label ↗AP
2018-04-26Labeling · Supplement 36 · standard — Label ↗AP
2015-07-31Labeling · Supplement 31 · standard — Label ↗AP
2014-06-11Labeling · Supplement 30 · standard — Label ↗AP
2013-10-17Labeling · Supplement 29 · standard — Label ↗AP
2012-03-29Labeling · Supplement 25 · standard — Label ↗AP
2010-12-20Labeling · Supplement 23 · 901 required — Letter ↗AP
2010-08-19Labeling · Supplement 11 · standard — Letter ↗AP
2009-05-22Manufacturing (CMC) · Supplement 19 — Letter ↗AP
2007-09-04Labeling · Supplement 18 · standard — Letter ↗AP
2006-09-13Labeling · Supplement 14 · standard — Letter ↗AP
2004-09-17Labeling · Supplement 10 · standard — Letter ↗AP
2002-10-29Manufacturing (CMC) · Supplement 6 · standardAP
2002-03-20Manufacturing (CMC) · Supplement 5 · standardAP
2001-11-05Manufacturing (CMC) · Supplement 3 · standardAP
2001-03-06Manufacturing (CMC) · Supplement 2 · standardAP
2000-10-24Manufacturing (CMC) · Supplement 1 · standardAP
2000-03-10Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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