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FDA Drug Application 205637 by BIODELIVERY SCI INTL

Application Number205637
Application Type New Drug Application
Sponsor ApplicantBIODELIVERY SCI INTL
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
AP06/6/2014N39458000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205637Orig1s000ltr.pdf 6/10/2014
AP06/6/2014N39485000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205637s000lbl.pdf 6/10/2014
AP06/6/2014N41517000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=9 1/8/2015
AP06/6/2014N42930000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205637Orig1s000TOC.cfm 5/28/2015
AP06/6/2014N42931000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205637Orig1s000SumR.pdf 5/28/2015
AP04/24/2015SCM       
AP02/12/2015S41856004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205637Orig1s004ltr.pdf 2/17/2015
AP010/14/2015SCM       
AP07/7/2016S46486009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205637Orig1s009ltr.pdf 7/11/2016
AP09/20/2016SCM       




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