Drugs@FDA: FDA-Approved Drugs

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

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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