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FDA Drug Application 065413 by ROXANE

Application Number065413
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
AP07/29/2008N20467000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/065413s000ltr.pdf 8/4/2008
AP07/29/2008N20795000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111294.htm 9/19/2008
AP07/29/2008N21251000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/065413s000lbl.pdf 11/20/2008
AP07/29/2008N43236000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=37 7/6/2015
AP09/12/2014SCM       




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