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FDA Drug Application 020315 by ROXANE

Application Number020315
Application Type New Drug Application
Sponsor ApplicantROXANE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/9/1993N       
AP012/27/1996SCM       
AP07/16/1997SCF       
AP08/8/1997SCS       
AP012/27/1996SCP       
AP07/2/1998SCM       
AP03/30/2001SLR1551006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20315S6LTR.PDF 3/30/2001
AP03/1/2001SCS       
AP05/17/2001SLR       




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