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FDA Drug Application 022509 by SMITHKLINE BEECHAM

Application Number022509
Application Type New Drug Application
Sponsor ApplicantSMITHKLINE BEECHAM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/29/2010N24759000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022509lbl.pdf 2/16/2010
AP01/29/2010N24798000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022509s000ltr.pdf 2/17/2010
AP01/29/2010N27111000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022509_lamictal_xr_toc.cfm 12/1/2010
AP01/29/2010N27910000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022509Orig1s000SumR.pdf 2/17/2011
AP01/29/2010N28722000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm254322.pdf 5/6/2011




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