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FDA Drug Application 016785 by SIGMA TAU

Application Number016785
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 Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/22/1969N       
AP04/8/1976SCS       
AP05/16/1977SCS       
AP011/27/1978SCS       
AP01/9/1979SCS       
AP03/24/1980SLR       
AP08/11/1981SLR       
AP011/14/1979SCP       
AP07/24/1980SCF       
AP03/31/1981SCM       
AP012/18/1981SCF       
AP04/29/1986SPD       
AP08/17/1987SLR       
AP03/5/1987SCM       
AP05/7/1986SLR       
AP04/9/1987SLR       
AP010/16/1998SCS       
AP03/8/1999SCS       
AP03/2/2001SCS       
AP011/13/2001SCE       
AP03/13/2002SCM       
AP012/20/2002SLR3519035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16785slr035ltr.pdf 1/29/2003
AP02/2/2016SCM       




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