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FDA Drug Application 125326 by GLAXO GRP LTD

Application Number125326
Application Type Biologic License Application
Sponsor ApplicantGLAXO GRP LTD
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
AP010/26/2009N23694000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125326lbl.pdf 10/27/2009
AP010/26/2009N23717000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125326s000ltr.pdf 11/2/2009
AP010/26/2009N24582000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125326s000TOC.cfm 1/22/2010
AP010/26/2009N24583000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125326s000_SumR.pdf 1/22/2010
AP010/26/2009N38190000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm379961.htm 12/27/2013
AP09/20/2011S300660032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125326s0032ltr.pdf 9/23/2011
AP09/20/2011S300720032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125326s0032lbl.pdf 9/23/2011
AP09/24/2013SLR37226059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125326Orig1s059ltr.pdf 9/26/2013
AP09/24/2013SLR37253059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125326s059lbl.pdf 9/27/2013
AP04/17/2014SE839085060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125326s060lbl.pdf 4/17/2014
AP04/17/2014SE839093060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125326Orig1s060ltr.pdf 4/18/2014
AP01/15/2016S44975062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125326s062lbl.pdf 1/19/2016
AP01/15/2016S44994062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125326Orig1s062ltr.pdf 1/21/2016
AP08/30/2016S46941063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125326Orig1s063ltr.pdf 9/2/2016
AP08/30/2016S46958063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125326s063lbl.pdf 9/2/2016




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