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FDA Drug Application 076504 by ROXANE

Application Number076504
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
AP02/22/2006N13681000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76504ltr.pdf 3/1/2006
AP02/22/2006N27432000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/076504_original approval_package.pdf 1/4/2011




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