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FDA Drug Application 018558 by ROXANE

Application Number018558
Application Type 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
AP01/29/1982N       
AP02/2/1995SL       
AP08/28/1996SC       
AP010/2/1996SC       
AP01/6/2000SCB       
AP01/6/2000SCS       
AP01/6/2000SCR       
AP01/6/2000SCP       
AP010/25/2016SLR47508021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017812Orig1s027,018421Orig1s025,018558Orig1s021ltr.pdf 10/28/2016
AP05/6/2016SCM       




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