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FDA Drug Application 022083 by NOVARTIS

Application Number022083
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
AP07/6/2007N17214000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022083lbl.pdf 7/9/2007
AP07/6/2007N22646000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022083_exelon_toc.cfm 5/28/2009
AP08/27/2010SLR26321008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022083s008ltr.pdf 8/31/2010
AP08/27/2010SLR26393008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022083s008lbl.pdf 9/7/2010
AP08/31/2012S33643016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022083Orig1s016ltr.pdf 9/5/2012
AP08/31/2012S33671016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022083s016lbl.pdf 9/6/2012
AP03/13/2013SCM       
AP06/27/2013SE836403019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022083Orig1s019ltr.pdf 7/1/2013
AP06/27/2013SE836533019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022083s019lbl.pdf 7/11/2013
AP02/3/2015SLR41780020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022083Orig1s020ltr.pdf 2/5/2015
AP02/3/2015SLR41791020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022083s020lbl.pdf 2/5/2015
AP06/24/2015SCM       




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