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FDA Drug Application 200652 by ROXANE

Application Number200652
Application Type Abbreviated New Drug Application
Sponsor ApplicantROXANE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/4/2015N42736000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200652Orig1s000ltr.pdf 5/5/2015
AP05/4/2015N42752000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200652Orig1s000lbl.pdf 5/7/2015
AP05/4/2015N42781000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=347 5/12/2015




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