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FDA Drug Application 050625 by NOVARTIS

Application Number050625
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/2/1990N       
AP011/21/1991SCP       
AP08/24/1990SLR       
AP012/30/1992SCS       
AP012/30/1992SCE       
AP06/10/1991SLR       
AP02/21/1992SCS       
AP011/23/1992SCS       
AP03/19/1993SCS       
AP011/2/1992SCP       
AP05/17/1993SCP       
AP05/9/1994SCS       
AP05/9/1994SCS       
AP03/7/1995SCM       
AP011/10/1994SLR       
AP01/13/1995SCS       
AP011/21/1995SCE       
AP011/21/1995SLR       
AP08/9/1996SLR       
AP04/15/1996SCS       
AP03/30/1998SCM       
AP010/4/2000SLR       
AP012/21/1999SLR       
AP06/30/2000SCM       
AP02/14/2003SLR4099030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050625s030lbl.pdf 3/5/2003
AP02/14/2003SLR9415030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50625slr30,32,50574slr27,29,50573slr21,23ltr.pdf 6/17/2004
AP02/14/2003SLR4100032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050625s030lbl.pdf 3/5/2003
AP02/14/2003SLR9416032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50625slr30,32,50574slr27,29,50573slr21,23ltr.pdf 6/17/2004
AP01/16/2002SCM       
AP04/12/2002SCM       
AP02/6/2004SLR7737039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50573slr027,028,50574slr035,037,50625slr039,040ltr.pdf 2/27/2004
AP02/6/2004SLR7819039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50573s027,028,50574s035,037,50625s039,040_sandimmune_lbl.pdf 3/3/2004
AP02/6/2004SLR7820040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50573s027,028,50574s035,037,50625s039,040_sandimmune_lbl.pdf 3/3/2004
AP02/6/2004SLR9414040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50573slr027,028,50574slr035,037,50625slr039,040ltr.pdf 6/17/2004
AP07/19/2005SLR12275043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050573s030,050574s039,050625s043ltr.pdf 7/26/2005
AP07/19/2005SLR12287043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050573s030,050574s039,050625s043lbl.pdf 7/26/2005
AP03/6/2006SLR13745044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050573s031,050574s040,050625s044lbl.pdf 3/10/2006
AP03/6/2006SLR13820044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050573s031,050574s040,050625s044ltr.pdf 3/23/2006
AP010/8/2009SLR23583047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050573s033,050574s041,050625s047lbl.pdf 10/14/2009
AP010/8/2009SLR23773047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050573s033,050574s041,050625s047ltr.pdf 11/10/2009
AP04/30/2010SLR25467048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050625s048,050573s034,050574s042ltr.pdf 5/6/2010
AP04/30/2010SLR25488048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050625s048,050573s034,050574s042lbl.pdf 5/7/2010
AP08/30/2012SLR33622049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050573s035,050574s043,050625s049lbl.pdf 8/31/2012
AP08/30/2012SLR33635049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050573Orig1s035,050574Orig1s043,050625Orig1s049ltr.pdf 9/5/2012
AP05/3/2013SLR35974053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050573Orig1s039,050574Orig1s047,050625Orig1s053ltr.pdf 5/7/2013
AP05/3/2013SLR35989053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050573s039,050574s047,050625s053lbl.pdf 5/9/2013
AP03/31/2015SLR42357055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050573s041,050574s051,050625s055lbl.pdf 4/1/2015
AP03/31/2015SLR42377055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050573Orig1s041,050574Orig1s051,050625Orig1s055ltr.pdf 4/2/2015
AP01/6/2016SCM       




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