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FDA Drug Application 077795 by ROXANE

Application Number077795
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
AP010/9/2007N18186000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077795s000ltr.pdf 10/10/2007
AP010/9/2007N18212000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077795s000lbl.pdf 10/10/2007
AP010/9/2007N18294000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm 10/23/2007




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