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FDA Drug Application 022115 by GLAXOSMITHKLINE LLC

Application Number022115
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE LLC
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
AP05/29/2009N22723000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022115s000ltr.pdf 6/10/2009
AP05/29/2009N22737000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022115lbl.pdf 6/10/2009
AP05/29/2009N23458000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM166013.pdf 9/25/2009
AP05/29/2009N24748000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022115s000TOC.cfm 2/14/2010
AP05/29/2009N24751000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022115s000_SumR.pdf 2/14/2010
AP04/14/2010SCM25281001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022115s001,s005ltr.pdf 4/19/2010
AP04/14/2010SCM25292001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022115s001s005lbl.pdf 4/19/2010
AP012/20/2013SLR38144003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022115 s003lbl.pdf 12/23/2013
AP012/20/2013SLR38177003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020241Orig1s039;020764Orig1s032;022251Orig1s001;022115Orig1s003ltr.pdf 12/26/2013
AP012/30/2014SLR41507004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s028s033,022115s004s014,022251s002s009ltr.pdf 1/7/2015
AP012/30/2014SLR41530004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022115s004s014lbl.pdf 1/8/2015
AP04/14/2010SLR25282005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022115s001,s005ltr.pdf 4/19/2010
AP04/14/2010SLR25293005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022115s001s005lbl.pdf 4/19/2010
AP04/25/2011SE528613006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022115s006lbl.pdf 4/25/2011
AP04/25/2011SE528618006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022115s006ltr.pdf 4/28/2011
AP010/24/2010SLR26783009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022115s009s010lbl.pdf 10/26/2010
AP010/24/2010SLR26784010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022115s009s010lbl.pdf 10/26/2010
AP03/24/2015SLR42276011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,020764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf 3/25/2015
AP03/24/2015SLR42279011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022115s011s018lbl.pdf 3/25/2015
AP08/4/2011SLR29688013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022115s013lbl.pdf 8/5/2011
AP08/4/2011SLR29709013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022115s013,020241s047,020764s040,022251s010ltr.pdf 8/8/2011
AP012/30/2014SLR41508014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s028s033,022115s004s014,022251s002s009ltr.pdf 1/7/2015
AP012/30/2014SLR41531014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022115s004s014lbl.pdf 1/8/2015
AP06/21/2011SCM29286015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022115s015ltr.pdf 6/27/2011
AP06/21/2011SCM29320015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022115s015lbl.pdf 6/29/2011
AP011/29/2011SLR30841016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020241s049,020764s042,022251s012,022115s016ltr.pdf 12/2/2011
AP011/29/2011SLR30901016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022115s016lbl.pdf 12/8/2011
AP08/1/2012SLR33334017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020241Orig1s050,020764Orig1s043,022251Orig1s013,022115Orig1s017ltr.pdf 8/2/2012
AP08/1/2012SLR33338017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022115s017lbl.pdf 8/2/2012
AP03/24/2015SLR42277018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,020764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf 3/25/2015
AP03/24/2015SLR42280018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022115s011s018lbl.pdf 3/25/2015
AP06/10/2014SLR39527019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241Orig1s052,020764Orig1s045,022251Orig1s016,022115Orig1s019ltr.pdf 6/12/2014
AP06/10/2014SLR39687019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022115s019lbl.pdf 6/30/2014




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