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FDA Drug Application 022251 by GLAXOSMITHKLINE LLC

Application Number022251
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
AP05/8/2009N22571000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022251s000ltr.pdf 5/13/2009
AP05/8/2009N22891000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022251,020764s029,020241s036lbl.pdf 7/8/2009
AP05/8/2009N23457000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM152835.pdf 9/25/2009
AP05/8/2009N25627000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022251_lamictal_odt_lamotrigine.cfm 5/27/2010
AP05/8/2009N25628000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022251s000_SumR.pdf 5/27/2010
AP012/20/2013SLR38141001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020241s039,020764s032,022251s001lbl.pdf 12/23/2013
AP012/20/2013SLR38176001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020241Orig1s039;020764Orig1s032;022251Orig1s001;022115Orig1s003ltr.pdf 12/26/2013
AP012/30/2014SLR41483002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s033,022251s002s009lbl.pdf 1/5/2015
AP012/30/2014SLR41509002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s028s033,022115s004s014,022251s002s009ltr.pdf 1/7/2015
AP010/24/2010SLR26807005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020241s043s044,020764s036s037,022251s005s006lbl.pdf 10/28/2010
AP010/24/2010SLR26868005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020241s043,s044,020764s036,s037,022251s005,s006ltr.pdf 11/3/2010
AP010/24/2010SLR26806006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020241s043s044,020764s036s037,022251s005s006lbl.pdf 10/28/2010
AP010/24/2010SLR26869006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020241s043,s044,020764s036,s037,022251s005,s006ltr.pdf 11/3/2010
AP03/24/2015SLR42274007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,020764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf 3/25/2015
AP03/24/2015SLR42285007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf 3/25/2015
AP012/30/2014SLR41484009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s033,022251s002s009lbl.pdf 1/5/2015
AP012/30/2014SLR41510009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s028s033,022115s004s014,022251s002s009ltr.pdf 1/7/2015
AP08/4/2011SLR29692010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s047,020764s040,022251s010lbl.pdf 8/5/2011
AP08/4/2011SLR29713010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022115s013,020241s047,020764s040,022251s010ltr.pdf 8/8/2011
AP05/31/2011SLR29020011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020241s048,020764s041,022251s011ltr.pdf 6/2/2011
AP011/29/2011SLR30840012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020241s049,020764s042,022251s012,022115s016ltr.pdf 12/2/2011
AP011/29/2011SLR30870012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s049,020764s042,022251s012lbl.pdf 12/2/2011
AP08/1/2012SLR33335013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020241Orig1s050,020764Orig1s043,022251Orig1s013,022115Orig1s017ltr.pdf 8/2/2012
AP08/1/2012SLR33339013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020241s050,020764s043,022251s013lbl.pdf 8/2/2012
AP03/24/2015SLR42275014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,020764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf 3/25/2015
AP03/24/2015SLR42286014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf 3/25/2015
AP06/10/2014SLR39526016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241Orig1s052,020764Orig1s045,022251Orig1s016,022115Orig1s019ltr.pdf 6/12/2014
AP06/10/2014SLR39690016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s052,020764s045,022251s016lbl.pdf 6/30/2014
AP05/18/2015SE842842017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022251Orig1s017,020241Orig1s053,020764Orig1s046ltr.pdf 5/20/2015
AP05/18/2015SE842864017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s053,020764s046,022251s017lbl.pdf 5/21/2015




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