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FDA Drug Application 087393 by ROXANE

Application Number087393
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
AP05/22/1981N43163000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 6/30/2015
AP08/6/1984SC       
AP011/4/1987SC       
AP011/4/1987SC       
AP011/4/1987SC       
AP02/23/1988SC       
AP07/17/1991SC       
AP04/2/1991SL       
AP05/10/1991SL       
AP08/28/1996SC       
AP02/17/1999SC       
AP03/9/1998SC       
AP03/9/1998SC       
AP03/9/1998SC       
AP02/17/1999SC       
AP011/17/1999SC       
AP011/17/1999SC       
AP04/16/2014SLR39242033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087393Orig1s033lbl.pdf 5/6/2014




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