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FDA Drug Application 018498 by ASTELLAS

Application Number018498
Application Type New Drug Application
Sponsor ApplicantASTELLAS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/13/1981N       
AP03/18/1982SCF       
AP05/9/1985SCS       
AP08/26/1986SCP       
AP02/2/1989SLR       
AP011/29/1991SCS       
AP08/9/1995SCS       
AP09/3/2002SLR2652008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18498slr008ltr.pdf 9/3/2002
AP09/3/2002SLR2653008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18498s8lbl.pdf 9/3/2002
AP09/4/1998SCM       
AP08/11/1999SCP       
AP06/16/1999SCP       




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