Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019596
Company: BAYER HLTHCARE
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 |