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FDA Drug Application 200068 by ROXANE

Application Number200068
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
TA012/2/2013TA37971000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200068Orig1s000TAltr.pdf 12/5/2013
AP16/3/2015N37971000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200068Orig1s000TAltr.pdf 12/5/2013
TA012/2/2013TA42983000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200068Orig1s000ltr.pdf 6/4/2015
AP16/3/2015N42983000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200068Orig1s000ltr.pdf 6/4/2015




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