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FDA Drug Application 022416 by SUNOVION PHARMS INC

Application Number022416
Application Type New Drug Application
Sponsor ApplicantSUNOVION PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/8/2013N37802000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022416Orig1s000ltr.pdf 11/13/2013
AP011/8/2013N37835000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022416s000lbl.pdf 11/15/2013
AP011/8/2013N38131000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022416Orig1s000TOC.cfm 12/20/2013
AP011/8/2013N38132000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022416Orig1s000TOC.cfm 12/20/2013
AP08/27/2015SE843747001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022416s001lbl.pdf 8/28/2015
AP08/27/2015SE843761001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022416Orig1s001ltr.pdf 9/1/2015
AP06/11/2015SCM       
AP09/10/2015SCM       
AP01/6/2016SCM       




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