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FDA Drug Application 050573 by NOVARTIS

Application Number050573
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
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
AP011/14/1983N       
AP03/19/1993SCS       
AP03/19/1993SCE       
AP06/10/1991SLR       
AP02/21/1992SCS       
AP03/19/1993SCS       
AP05/9/1994SCS       
AP05/9/1994SCS       
AP03/7/1995SCM       
AP011/10/1994SLR       
AP08/9/1996SLR       
AP08/2/1996SCS       
AP03/30/1998SCM       
AP010/20/1998SCM       
AP05/13/1999SCM       
AP012/21/1999SLR       
AP010/4/2000SLR       
AP04/4/2001SCM       
AP03/9/2001SCS       
AP03/5/2003SLR4103021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050625s030lbl.pdf 3/5/2003
AP03/5/2003SLR9417021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50625slr30,32,50574slr27,29,50573slr21,23ltr.pdf 6/17/2004
AP02/14/2003SLR9418023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50625slr30,32,50574slr27,29,50573slr21,23ltr.pdf 6/17/2004
AP02/14/2003SLR4104023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050625s030lbl.pdf 3/5/2003
AP01/16/2002SCM       
AP04/12/2002SCM       
AP02/6/2004SLR7733027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50573slr027,028,50574slr035,037,50625slr039,040ltr.pdf 2/27/2004
AP02/6/2004SLR7815027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50573s027,028,50574s035,037,50625s039,040_sandimmune_lbl.pdf 3/3/2004
AP02/6/2004SLR7816028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50573s027,028,50574s035,037,50625s039,040_sandimmune_lbl.pdf 3/3/2004
AP02/6/2004SLR7734028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50573slr027,028,50574slr035,037,50625slr039,040ltr.pdf 2/27/2004
AP07/19/2005SLR12273030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050573s030,050574s039,050625s043ltr.pdf 7/26/2005
AP07/19/2005SLR12289030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050573s030,050574s039,050625s043lbl.pdf 7/26/2005
AP03/6/2006SLR13747031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050573s031,050574s040,050625s044lbl.pdf 3/10/2006
AP03/6/2006SLR13822031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050573s031,050574s040,050625s044ltr.pdf 3/23/2006
AP010/8/2009SLR23585033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050573s033,050574s041,050625s047lbl.pdf 10/14/2009
AP010/8/2009SLR23771033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050573s033,050574s041,050625s047ltr.pdf 11/10/2009
AP04/30/2010SLR25468034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050625s048,050573s034,050574s042ltr.pdf 5/6/2010
AP04/30/2010SLR25487034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050625s048,050573s034,050574s042lbl.pdf 5/7/2010
AP08/30/2012SLR33624035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050573s035,050574s043,050625s049lbl.pdf 8/31/2012
AP08/30/2012SLR33633035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050573Orig1s035,050574Orig1s043,050625Orig1s049ltr.pdf 9/5/2012
AP02/7/2013SCM       
AP05/3/2013SLR35972039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050573Orig1s039,050574Orig1s047,050625Orig1s053ltr.pdf 5/7/2013
AP05/3/2013SLR35991039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050573s039,050574s047,050625s053lbl.pdf 5/9/2013
AP011/2/2015SCM       
AP03/31/2015SLR42359041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050573s041,050574s051,050625s055lbl.pdf 4/1/2015
AP03/31/2015SLR42375041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050573Orig1s041,050574Orig1s051,050625Orig1s055ltr.pdf 4/2/2015




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