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FDA Drug Application 021730 by SUNOVION

Application Number021730
Application Type New Drug Application
Sponsor ApplicantSUNOVION
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
AP03/11/2005N15456000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021730s000TOC.cfm 12/13/2006
AP03/11/2005N11242000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21730ltr.pdf 3/14/2005
AP03/11/2005N11251000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21730lbl.pdf 3/14/2005
AP09/15/2006SLR14908003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021730s003ltr.pdf 9/20/2006
AP04/4/2006SLR13875006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021730s006ltr.pdf 4/7/2006
AP02/5/2008SCS19066008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021730s008ltr.pdf 2/7/2008
AP02/5/2008SCS19122008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021730s008lbl.pdf 2/14/2008
AP07/30/2012SLR33322024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021730s024lbl.pdf 7/30/2012
AP07/30/2012SLR33329024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021730Orig1s024ltr.pdf 8/1/2012
AP012/7/2012SCM       
AP01/9/2013SCM       
AP03/14/2013SCM       
AP09/10/2013SLR37068033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021730s033lbl.pdf 9/11/2013
AP09/10/2013SLR37075033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021730Orig1s033ltr.pdf 9/12/2013
AP011/25/2013SCM       
AP08/27/2014SCM       
AP03/12/2015SE842146036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021730Orig1s036ltr.pdf 3/13/2015
AP03/12/2015SE842179036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021730s036lbl.pdf 3/17/2015
AP01/22/2016SCM       




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