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FDA Drug Application 050715 by NOVARTIS

Application Number050715
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       
AP010/11/1996SCS       
AP06/19/1997SLR       
AP03/30/1998SCM       
AP010/4/2000SLR       
AP012/21/1999SLR       
AP06/30/2000SCM       
AP06/12/2002SLR2928010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50715s010ltr.pdf 6/12/2002
AP06/12/2002SLR2929010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50715s10s14lbl.pdf 6/12/2002
AP01/16/2002SCM       
AP04/12/2002SCM       
AP06/12/2002SLR2930014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50715s010ltr.pdf 6/12/2002
AP06/12/2002SLR2931014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50715s10s14lbl.pdf 6/12/2002
AP09/26/2002SCS       
AP02/6/2004SLR7814019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50716slr020,021,50715slr019,020_neoral_lbl.pdf 3/3/2004
AP02/6/2004SLR9250019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50716slr020,021,50715slr019,020ltr.pdf 6/9/2004
AP02/6/2004SLR9251020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50716slr020,021,50715slr019,020ltr.pdf 6/9/2004
AP02/6/2004SLR9252020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50716slr020,021,50715slr019,020_neoral_lbl.pdf 6/9/2004
AP07/19/2005SLR12277022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050715s022,050716s024ltr.pdf 7/26/2005
AP07/19/2005SLR12291022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050715s022,050716s024lbl.pdf 7/26/2005
AP03/6/2006SLR13749024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050715s024,050716s025lbl.pdf 3/10/2006
AP03/6/2006SLR13819024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050715s024,050716s025ltr.pdf 3/23/2006
AP08/1/2007SLR17451025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050715s25,050716s26lbl.pdf 8/2/2007
AP08/1/2007SLR17460025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050715s028, 050716s026ltr.pdf 8/2/2007
AP09/24/2009SLR23501027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050715s027,050716s028lbl.pdf 10/1/2009
AP09/24/2009SLR23857027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050715s027,050716s028ltr.pdf 11/12/2009
AP010/8/2009SLR23578028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050715s028,050716s029lbl.pdf 10/14/2009
AP010/8/2009SLR23757028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050715s028ltr.pdf 11/9/2009
AP08/30/2012SLR33626029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050715s029,050716s030lbl.pdf 8/31/2012
AP08/30/2012SLR33636029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050715Orig1s029,050716Orig1s030ltr.pdf 9/5/2012
AP05/2/2013SLR35955033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050715Orig1s033,050716Orig1s034ltr.pdf 5/7/2013
AP05/2/2013SLR36001033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050715s033,050716s034lbl.pdf 5/9/2013
AP03/31/2015SLR42362035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050715s035,050716s038lbl.pdf 4/1/2015
AP03/31/2015SLR42372035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050715Orig1s035,050716Orig1s038ltr.pdf 4/2/2015
AP010/11/2016SCM       




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