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FDA Drug Application 019937 by ASTELLAS

Application Number019937
Application Type New Drug Application
Sponsor ApplicantASTELLAS
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
AP010/30/1989N       
AP012/4/1989SCS       
AP05/10/1990SLR       
AP04/25/1994SCP       
AP09/13/1990SLR       
AP011/15/1990SCS       
AP06/11/1992SLR       
AP010/27/1993SCS       
AP06/9/1995SLR       
AP06/26/1995SCS       
AP02/9/1996SLR       
AP012/27/1995SCS       
AP07/29/1996SLR       
AP02/13/1997SCS       
AP04/20/1999SLR       
AP011/2/1999SCS       
AP02/1/2000SCM       
AP09/21/2001SCP       
AP07/14/2005SLR12026021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019937s021,020059s011ltr.pdf 7/21/2005
AP011/6/2009SLR24029024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019937s024lbl.pdf 11/19/2009
AP011/6/2009SLR24466024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019937s024ltr.pdf 1/7/2010
AP02/23/2011SLR27976026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019937s026ltr.pdf 2/28/2011
AP02/23/2011SLR28034026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019937s026lbl.pdf 3/4/2011
AP012/13/2013SCM       




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