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FDA Drug Application 077728 by ROXANE

Application Number077728
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
TA011/30/2007TA18869000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077728s000TAltr.pdf 1/9/2008
AP12/26/2008N18869000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077728s000TAltr.pdf 1/9/2008
TA011/30/2007TA19310000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077728s000ltr.pdf 2/27/2008
AP12/26/2008N19310000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077728s000ltr.pdf 2/27/2008




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