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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021037
Company: BAYER HLTHCARE

Medication Guide

Other Important Information from FDA

Products on NDA 021037

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MAGNEVIST	GADOPENTETATE DIMEGLUMINE	469.01MG/ML	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021037

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/10/2000	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21037_Magnevist.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/25/2018	SUPPL-38	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021037s037s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021037Orig1s037,s038Ltr.pdf
07/25/2018	SUPPL-37	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021037s037s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021037Orig1s037,s038Ltr.pdf
04/26/2018	SUPPL-36	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021037s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019596Orig1s063,021037Orig1s036_replacement ltr.pdf
07/31/2015	SUPPL-31	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021037s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021037Orig1s031ltr.pdf
06/11/2014	SUPPL-30	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019596s057,021037s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019596Orig1s057,021037Orig1s030ltr.pdf
10/17/2013	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019596s056,021037s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019596Orig1s056,021037Orig1s029ltr.pdf
03/29/2012	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021037s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019596s051,021037s025ltr.pdf
12/20/2010	SUPPL-23	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021037s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019596s049,021037s023ltr.pdf
05/22/2009	SUPPL-19	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019596s045,021037s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019596s045,021037s019ltr.pdf
09/04/2007	SUPPL-18	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019596s043,021037s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019596s043, 021037s018ltr.pdf
09/13/2006	SUPPL-14	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021037s014ltr.pdf
08/19/2010	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019596s034,021037s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019596s034,021037s011ltr.pdf
09/17/2004	SUPPL-10	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21037s010ltr.pdf
10/29/2002	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/20/2002	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/05/2001	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
03/06/2001	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
10/24/2000	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021037

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/25/2018	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021037s037s038lbl.pdf
07/25/2018	SUPPL-38	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021037s037s038lbl.pdf
07/25/2018	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021037s037s038lbl.pdf
04/26/2018	SUPPL-36	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021037s036lbl.pdf
07/31/2015	SUPPL-31	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021037s031lbl.pdf
06/11/2014	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019596s057,021037s030lbl.pdf
10/17/2013	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019596s056,021037s029lbl.pdf
03/29/2012	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021037s025lbl.pdf
12/20/2010	SUPPL-23	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021037s023lbl.pdf
08/19/2010	SUPPL-11	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019596s034,021037s011lbl.pdf
05/22/2009	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019596s045,021037s019lbl.pdf
05/22/2009	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019596s045,021037s019lbl.pdf
09/04/2007	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019596s043,021037s018lbl.pdf

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