Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019596
Company: BAYER HLTHCARE

• Medication Guide

• Other Important Information from FDA

Products on NDA 19596

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

Labels for NDA 019596

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/25/2018	SUPPL-65	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019596s064s065lbl.pdf
07/25/2018	SUPPL-65	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019596s064s065lbl.pdf
07/25/2018	SUPPL-64	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019596s064s065lbl.pdf
04/26/2018	SUPPL-63	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019596s063lbl.pdf
06/11/2014	SUPPL-57	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019596s057lbl.pdf
10/17/2013	SUPPL-56	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019596s056,021037s029lbl.pdf
03/29/2012	SUPPL-51	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019596s051lbl.pdf
12/20/2010	SUPPL-49	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019596s049lbl.pdf
08/19/2010	SUPPL-34	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019596s034,021037s011lbl.pdf
05/22/2009	SUPPL-45	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019596s045,021037s019lbl.pdf
09/04/2007	SUPPL-43	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019596s043,021037s018lbl.pdf
01/21/2005	SUPPL-33	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19596s033lbl.pdf