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FDA Drug Application 078582 by ROXANE

Application Number078582
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
AP01/15/2009N21667000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078582s000ltr.pdf 1/21/2009
AP01/15/2009N21736000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm 2/4/2009




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