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FDA Drug Application 203856 by ROXANE

Application Number203856
Application Type New Drug Application
Sponsor ApplicantROXANE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/16/2013N37153000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203856s000lbl.pdf 9/18/2013
AP09/16/2013N37162000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203856Orig1s000ltr.pdf 9/19/2013
AP09/16/2013N38700000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203856Orig1s000TOC.cfm 3/6/2014
AP09/16/2013N38701000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203856Orig1s000SumR.pdf 3/6/2014




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