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FDA Drug Application 020356 by SHIONOGI INC

Application Number020356
Application Type New Drug Application
Sponsor ApplicantSHIONOGI INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/2/1995N       
AP07/26/1995SCM       
AP012/5/1995SLR       
AP01/5/1996SCS       
AP010/23/1996SLR       
AP02/19/1997SLR       
AP01/24/1997SCS       
AP01/19/2000SLR3322007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20356-s007_sular.pdf 6/4/2001
AP01/19/2000SLR3323008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20356-s007_sular.pdf 6/4/2001
AP012/16/1998SLR       
AP012/13/1999SCM       
AP09/26/2000SLR       
AP03/14/2001SCS       
AP08/13/2002SCM       
AP010/11/2002SCM       
AP01/2/2008SCF18809019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020356s019ltr_CKD.pdf 1/9/2008
AP01/2/2008SCF31917019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/020356Orig1s019.pdf 2/28/2012
AP05/20/2016SCM       




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