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FDA Drug Application 018513 by SIGMA TAU

Application Number018513
Application Type New Drug Application
Sponsor ApplicantSIGMA TAU
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
AP07/28/1983N       
AP04/17/1984SCS       
AP04/25/1986SCF       
AP04/25/1986SCF       
AP012/18/1984SCF       
AP04/17/1984SCP       
AP04/24/1986SLR       
AP012/22/1986SLR       
AP011/16/1988SLR       
AP01/3/1990SLR       
AP05/20/2010SLR25607012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018513s012ltr.pdf 5/24/2010




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