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FDA Drug Application 020586 by OTSUKA AMERICA

Application Number020586
Application Type New Drug Application
Sponsor ApplicantOTSUKA AMERICA
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
AP09/17/1996N       
AP04/23/1997SCE       
AP03/13/1998SLR       
AP05/13/1999SCS       
AP05/10/2001SE25476004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20586s4lbl.pdf 4/25/2003
AP05/10/2001SE26135004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20586-S004%20AP%20ltr.pdf 7/24/2003
AP05/10/2001SE29743004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-586s004_Pranactin.cfm 7/15/2004




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