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FDA Drug Application 050574 by NOVARTIS

Application Number050574
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
AP011/14/1983N       
AP02/16/1993SCS       
AP02/24/1993SCE       
AP03/14/1991SCS       
AP06/10/1991SLR       
AP02/21/1992SCS       
AP02/11/1993SCF       
AP03/19/1993SCS       
AP05/9/1994SCS       
AP05/9/1994SCS       
AP05/19/1994SCF       
AP03/7/1995SCM       
AP011/10/1994SLR       
AP04/28/1995SCS       
AP011/21/1995SLR       
AP08/9/1996SLR       
AP03/22/1996SCS       
AP03/30/1998SCM       
AP01/30/1998SCS       
AP07/27/1998SCS       
AP010/20/1998SCM       
AP05/13/1999SCM       
AP010/4/2000SLR       
AP012/21/1999SLR       
AP02/14/2003SLR4101027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050625s030lbl.pdf 3/5/2003
AP02/14/2003SLR9419027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50625slr30,32,50574slr27,29,50573slr21,23ltr.pdf 6/17/2004
AP011/16/2001SCM       
AP02/14/2003SLR9420029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50625slr30,32,50574slr27,29,50573slr21,23ltr.pdf 6/17/2004
AP02/14/2003SLR4102029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050625s030lbl.pdf 3/5/2003
AP02/22/2002SCS       
AP01/16/2002SCM       
AP06/14/2002SCM       
AP04/12/2002SCM       
AP02/6/2004SLR7817035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50573s027,028,50574s035,037,50625s039,040_sandimmune_lbl.pdf 3/3/2004
AP02/6/2004SLR7735035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50573slr027,028,50574slr035,037,50625slr039,040ltr.pdf 2/27/2004
AP02/6/2004SLR7736037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50573slr027,028,50574slr035,037,50625slr039,040ltr.pdf 2/27/2004
AP02/6/2004SLR7818037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50573s027,028,50574s035,037,50625s039,040_sandimmune_lbl.pdf 3/3/2004
AP07/19/2005SLR12274039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050573s030,050574s039,050625s043ltr.pdf 7/26/2005
AP07/19/2005SLR12288039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050573s030,050574s039,050625s043lbl.pdf 7/26/2005
AP03/6/2006SLR13746040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050573s031,050574s040,050625s044lbl.pdf 3/10/2006
AP03/6/2006SLR13821040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050573s031,050574s040,050625s044ltr.pdf 3/23/2006
AP010/8/2009SLR23584041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050573s033,050574s041,050625s047lbl.pdf 10/14/2009
AP010/8/2009SLR23772041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050573s033,050574s041,050625s047ltr.pdf 11/10/2009
AP04/30/2010SLR25469042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050625s048,050573s034,050574s042ltr.pdf 5/6/2010
AP04/30/2010SLR25486042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050625s048,050573s034,050574s042lbl.pdf 5/7/2010
AP08/30/2012SLR33623043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050573s035,050574s043,050625s049lbl.pdf 8/31/2012
AP08/30/2012SLR33634043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050573Orig1s035,050574Orig1s043,050625Orig1s049ltr.pdf 9/5/2012
AP05/3/2013SLR35973047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050573Orig1s039,050574Orig1s047,050625Orig1s053ltr.pdf 5/7/2013
AP05/3/2013SLR35990047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050573s039,050574s047,050625s053lbl.pdf 5/9/2013
AP01/22/2014SCM       
AP03/31/2015SLR42358051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050573s041,050574s051,050625s055lbl.pdf 4/1/2015
AP03/31/2015SLR42376051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050573Orig1s041,050574Orig1s051,050625Orig1s055ltr.pdf 4/2/2015
AP07/14/2016SCM       




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