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FDA Drug Application 019596 by BAYER HLTHCARE

Application Number019596
Application Type New Drug Application
Sponsor ApplicantBAYER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/2/1988N14264000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm 6/9/2006
AP04/28/1989SE1       
AP03/23/1989SCS       
AP02/2/1989SLR       
AP08/10/1989SE5       
AP02/12/1992SCF       
AP08/22/1990SLR       
AP08/17/1993SE127729008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019596a_s08_s09_022896_Magnevist.pdf 2/4/2011
AP02/28/1996SE527730009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019596a_s08_s09_022896_Magnevist.pdf 2/4/2011
AP03/3/1995SCS       
AP011/16/1995SCS       
AP03/14/1996SCS       
AP03/14/1996SCS       
AP09/25/1997SCS       
AP010/26/1998SCP       
AP03/10/2000SLR       
AP02/5/1999SCM       
AP011/10/1999SCM       
AP010/24/2000SCM       
AP011/14/2000SCS       
AP04/18/2001SCM       
AP011/5/2001SCM       
AP010/29/2002SCM       
AP01/21/2005SLR11029033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19596s033ltr.pdf 1/26/2005
AP01/21/2005SLR11051033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19596s033lbl.pdf 1/26/2005
AP08/19/2010SLR26314034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019596s034,021037s011ltr.pdf 8/31/2010
AP08/19/2010SLR26414034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019596s034,021037s011lbl.pdf 9/7/2010
AP09/13/2006SLR14830039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019596s039ltr.pdf 9/15/2006
AP09/4/2007SLR17752043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019596s043,021037s018lbl.pdf 9/6/2007
AP09/4/2007SLR17766043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019596s043, 021037s018ltr.pdf 9/6/2007
AP05/22/2009SCS22607045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019596s045,021037s019lbl.pdf 5/25/2009
AP05/22/2009SCS22658045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019596s045,021037s019ltr.pdf 5/29/2009
AP012/20/2010SLR27316049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019596s049lbl.pdf 12/20/2010
AP012/20/2010SLR27355049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019596s049,021037s023ltr.pdf 12/22/2010
AP03/29/2012SLR32315051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019596s051lbl.pdf 3/29/2012
AP03/29/2012SLR32328051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019596s051,021037s025ltr.pdf 4/2/2012
AP011/30/2012SCM       
AP09/6/2013SCM       
AP010/17/2013SLR37459056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019596Orig1s056,021037Orig1s029ltr.pdf 10/18/2013
AP010/17/2013SLR37507056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019596s056,021037s029lbl.pdf 10/22/2013
AP06/11/2014SLR39522057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019596Orig1s057,021037Orig1s030ltr.pdf 6/12/2014
AP012/7/2015SCM       




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