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FDA Drug Application 087997 by ROXANE

Application Number087997
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
AP08/30/1982N43159000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 6/30/2015
AP02/4/1988SC       
AP01/31/1994SC       
AP012/24/1991SL       
AP012/24/1991SL       
AP08/28/1996SC       
AP03/2/1998SC       
AP03/2/1998SC       
AP03/3/1999SC       
AP03/2/1998SC       
AP03/3/1999SC       
AP02/1/2000SC       
AP04/16/2014SC40146024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/087997Orig1s024lbl.pdf 8/5/2014




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