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FDA Drug Application 204082 by ROXANE

Application Number204082
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
TA012/31/2014TA45183000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204082Orig1s000ltr.pdf 2/18/2016
AP12/16/2016N45183000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204082Orig1s000ltr.pdf 2/18/2016




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