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FDA Drug Application 019815 by SHIRE LLC

Application Number019815
Application Type New Drug Application
Sponsor ApplicantSHIRE LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/6/1996N       
AP05/16/1997SCM       
AP01/29/1999SCP       
AP01/28/1999SCM       
AP05/24/2000SCS       
AP03/20/2002SCM3939005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19815s5ltr.pdf 3/20/2002
AP03/20/2002SCM3940005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-815s005_Midodrine.htm 3/20/2002
AP03/20/2002SCM3941005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19-815s005_Midodrine.cfm 3/20/2002
AP02/22/2002SCE       
AP07/22/2004SLR9859007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19815s007ltr.pdf 7/28/2004




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