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FDA Drug Application 200822 by ROXANE

Application Number200822
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
AP07/15/2013N42096000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2013/200822Orig1s000.pdf 3/11/2015
AP07/15/2013N43139000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 6/30/2015




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