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FDA Drug Application 050716 by NOVARTIS

Application Number050716
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/14/1995N       
AP03/5/1997SCS       
AP06/19/1997SLR       
AP03/30/1998SCM       
AP01/30/1998SCS       
AP07/27/1998SCS       
AP07/24/1998SCM       
AP05/13/1999SCM       
AP010/4/2000SLR       
AP012/21/1999SLR       
AP011/29/2000SCM       
AP06/12/2002SLR2932014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50715s010ltr.pdf 6/12/2002
AP06/12/2002SLR2933014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50715s10s14lbl.pdf 6/12/2002
AP05/3/2001SCM       
AP02/22/2002SCS       
AP04/12/2002SCM       
AP06/12/2002SLR2934018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50715s010ltr.pdf 6/12/2002
AP06/12/2002SLR2935018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50715s10s14lbl.pdf 6/12/2002
AP02/6/2004SLR7730020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50716slr020,021,50715slr019,020ltr.pdf 2/27/2004
AP02/6/2004SLR7812020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50716slr020,021,50715slr019,020_neoral_lbl.pdf 3/3/2004
AP02/6/2004SLR7813021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50716slr020,021,50715slr019,020_neoral_lbl.pdf 3/3/2004
AP02/6/2004SLR7731021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50716slr020,021,50715slr019,020ltr.pdf 2/27/2004
AP07/19/2005SLR12276024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050715s022,050716s024ltr.pdf 7/26/2005
AP07/19/2005SLR12290024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050715s022,050716s024lbl.pdf 7/26/2005
AP03/6/2006SLR13748025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050715s024,050716s025lbl.pdf 3/10/2006
AP03/6/2006SLR13818025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050715s024,050716s025ltr.pdf 3/23/2006
AP08/1/2007SLR17450026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050715s25,050716s26lbl.pdf 8/2/2007
AP08/1/2007SLR17459026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050715s028, 050716s026ltr.pdf 8/2/2007
AP09/24/2009SLR23502028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050715s027,050716s028lbl.pdf 10/1/2009
AP09/24/2009SLR23858028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050715s027,050716s028ltr.pdf 11/12/2009
AP010/8/2009SLR23577029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050715s028,050716s029lbl.pdf 10/14/2009
AP010/8/2009SLR23758029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050716s029ltr.pdf 11/9/2009
AP08/30/2012SLR33625030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050715s029,050716s030lbl.pdf 8/31/2012
AP08/30/2012SLR33637030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050715Orig1s029,050716Orig1s030ltr.pdf 9/5/2012
AP05/2/2013SLR35956034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050715Orig1s033,050716Orig1s034ltr.pdf 5/7/2013
AP05/2/2013SLR36000034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050715s033,050716s034lbl.pdf 5/9/2013
AP08/29/2013SCM       
AP03/31/2015SLR42361038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050715s035,050716s038lbl.pdf 4/1/2015
AP03/31/2015SLR42373038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050715Orig1s035,050716Orig1s038ltr.pdf 4/2/2015




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