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FDA Drug Application 019425 by SEBELA IRELAND LTD

Application Number019425
Application Type New Drug Application
Sponsor ApplicantSEBELA IRELAND LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/31/1985N       
AP011/13/1986SLR       
AP05/22/1987SCP       
AP09/22/1987SLR       
AP011/13/1987SCM       
AP011/16/1987SCS       
AP010/19/1989SLR       
AP010/19/1989SLR       
AP03/23/1990SCS       
AP011/7/1990SLR       
AP06/7/1990SLR       
AP02/1/1991SLR       
AP06/5/1991SLR       
AP05/27/1993SLR       
AP04/20/1994SLR       
AP05/1/1997SCM       
AP08/13/1998SLR       
AP012/18/2002SCM       
AP011/22/2010SLR27063021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019425s021lbl.pdf 11/22/2010
AP011/22/2010SLR27078021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019425s021ltr.pdf 11/30/2010




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