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FDA Drug Application 204988 by ROXANE

Application Number204988
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
TA03/25/2015TA46043000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204988Orig1s000ltr.pdf 5/18/2016
TA03/25/2015TA46235000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204988Orig1s000lbl.pdf 6/1/2016
AP15/16/2016N46043000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204988Orig1s000ltr.pdf 5/18/2016
AP15/16/2016N46235000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204988Orig1s000lbl.pdf 6/1/2016




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