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FDA Drug Application 125011 by SMITHKLINE BEECHAM

Application Number125011
Application Type Biologic License Application
Sponsor ApplicantSMITHKLINE BEECHAM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/27/2003N78720000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/tosicor062703L.htm 3/10/2004
AP06/27/2003N78730000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/tosicor062703LB.pdf 3/10/2004
AP06/27/2003N227770000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/125011s000TOC.cfm 6/19/2009
AP012/22/2004S270550024   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2004/125011_s024_bexxar.pdf 12/22/2004
AP012/22/2004S108140024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125011_0024ltr.pdf 12/29/2004
AP012/22/2004S108340024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125011_0024lbl.pdf 12/29/2004
AP02/22/2012SCM       
AP02/18/2012SLR32031102   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125011s102ltr.pdf 3/5/2012
AP02/18/2012SLR33236102   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125011s102lbl.pdf 7/19/2012
AP08/15/2012SLR33492126   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125011s0126lbl.pdf 8/16/2012
AP08/15/2012SLR33498126   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125011Orig1s126ltr.pdf 8/17/2012




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