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FDA Drug Application 019334 by SOMERSET

Application Number019334
Application Type New Drug Application
Sponsor ApplicantSOMERSET
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
AP06/5/1989N       
AP03/26/1990SLR       
AP03/1/1990SCP       
AP07/25/1990SLR       
AP01/5/1993SLR       
AP01/5/1993SCM       
AP01/5/1993SLR       
AP01/5/1993SCS       
AP01/5/1993SCM       
AP02/12/1993SCS       
AP07/13/1994SCS       
AP08/6/1997SLR       
AP012/31/2008SLR21510019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019334s020,019334s019ltr.pdf 1/6/2009
AP012/31/2008SLR21538019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019334s019s020lbl.pdf 1/6/2009
AP012/31/2008SLR21539020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019334s019s020lbl.pdf 1/6/2009
AP012/31/2008SLR21511020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019334s020,019334s019ltr.pdf 1/6/2009




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