Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019596
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
06/02/1988 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/25/2018 SUPPL-65 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019596s064s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019596Orig1s064s065Ltr.pdf
07/25/2018 SUPPL-64 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019596s064s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019596Orig1s064s065Ltr.pdf
04/26/2018 SUPPL-63 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019596s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019596Orig1s063,021037Orig1s036_replacement ltr.pdf
12/22/2016 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

11/02/2016 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

12/07/2015 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

06/11/2014 SUPPL-57 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019596s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019596Orig1s057,021037Orig1s030ltr.pdf
10/17/2013 SUPPL-56 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
09/06/2013 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

11/30/2012 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

03/29/2012 SUPPL-51 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019596s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019596s051,021037s025ltr.pdf
12/20/2010 SUPPL-49 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019596s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019596s049,021037s023ltr.pdf
05/22/2009 SUPPL-45 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-43 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-39 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019596s039ltr.pdf
08/19/2010 SUPPL-34 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
01/21/2005 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19596s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19596s033ltr.pdf
10/29/2002 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

11/05/2001 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/18/2001 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

11/14/2000 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/2000 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/10/1999 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/05/1999 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/10/2000 SUPPL-18 Labeling

Label is not available on this site.

10/26/1998 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/25/1997 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/14/1996 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

03/14/1996 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

11/16/1995 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/1995 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1996 SUPPL-9 Efficacy-New Patient Population Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019596a_s08_s09_022896_Magnevist.pdf
08/17/1993 SUPPL-8 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019596a_s08_s09_022896_Magnevist.pdf
08/22/1990 SUPPL-7 Labeling

Label is not available on this site.

02/12/1992 SUPPL-6 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/10/1989 SUPPL-5 Efficacy-New Patient Population

Label is not available on this site.

02/02/1989 SUPPL-4 Labeling

Label is not available on this site.

03/23/1989 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

04/28/1989 SUPPL-1 Efficacy-New Indication

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-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

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