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FDA Drug Application 020764 by GLAXOSMITHKLINE LLC

Application Number020764
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
AP08/24/1998N205000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20764ltr.pdf 8/24/1998
AP08/24/1998N206000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020764a.cfm 5/20/1999
AP08/24/1998N207000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20764lbl.pdf 8/24/1998
AP08/24/1998N23456000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM152835.pdf 9/25/2009
AP012/14/1998SE12761001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20241s3ltr.pdf 12/14/1998
AP012/14/1998SE12762001   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20241s03lbl.pdf 12/14/1998
AP012/14/1998SE12763001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020241s003.cfm 6/30/1999
AP01/17/2003SE14205002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020241s008lbl.pdf 1/17/2003
AP09/25/2006SE136980003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf 9/6/2013
AP09/25/2006SE136981003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf 9/6/2013
AP06/8/1999SCM       
AP05/25/2001SE82766005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20764s5lbl.pdf 5/25/2001
AP05/25/2001SE813230005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020764_S005.pdf 12/8/2005
AP09/8/2000SCF       
AP02/23/2001SLR       
AP01/14/2004SE87587009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20241se8-016,20764se8-009ltr.pdf 1/22/2004
AP06/20/2003SE116653011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020241_S017_020764_S011TOC.cfm 5/29/2007
AP06/20/2003SE16049011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20241se1-017,20764se1-011ltr.pdf 7/6/2003
AP06/20/2003SE16072011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20241se1-017,20764se1-011_lamictal_lbl.pdf 7/8/2003
AP09/25/2006SLR36971014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf 9/6/2013
AP09/25/2006SLR36972014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf 9/6/2013
AP09/25/2006SLR36973018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf 9/6/2013
AP09/25/2006SLR36974018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf 9/6/2013
AP09/25/2006SLR36975019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf 9/6/2013
AP09/25/2006SLR36976019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf 9/6/2013
AP09/22/2006SE136977020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020764_s020_Lamictal-optimized.pdf 9/6/2013
AP09/22/2006SE136978020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf 9/6/2013
AP09/22/2006SE136979020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf 9/6/2013
AP03/17/2006SLR       
AP012/30/2014SLR41481028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s033,022251s002s009lbl.pdf 1/5/2015
AP012/30/2014SLR41505028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s028s033,022115s004s014,022251s002s009ltr.pdf 1/7/2015
AP05/8/2009SLR22573029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020764s029ltr.pdf 5/13/2009
AP05/8/2009SLR22703029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022251,020764s029,020241s036lbl.pdf 6/7/2009
AP04/23/2009SLR22532030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020241s037s038,020764s030s031lbl.pdf 5/12/2009
AP04/23/2009SLR22388030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020241s037,s038,020764s030,s031ltr.pdf 5/4/2009
AP04/23/2009SLR22389031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020241s037,s038,020764s030,s031ltr.pdf 5/4/2009
AP04/23/2009SLR22533031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020241s037s038,020764s030s031lbl.pdf 5/12/2009
AP012/20/2013SLR38142032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020241s039,020764s032,022251s001lbl.pdf 12/23/2013
AP012/20/2013SLR38175032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020241Orig1s039;020764Orig1s032;022251Orig1s001;022115Orig1s003ltr.pdf 12/26/2013
AP012/30/2014SLR41506033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s028s033,022115s004s014,022251s002s009ltr.pdf 1/7/2015
AP012/30/2014SLR41482033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s033,022251s002s009lbl.pdf 1/5/2015
AP010/24/2010SLR26866036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020241s043,s044,020764s036,s037,022251s005,s006ltr.pdf 11/3/2010
AP010/24/2010SLR26798036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020241s043s044,020764s036s037,022251s005s006lbl.pdf 10/28/2010
AP010/24/2010SLR26799037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020241s043s044,020764s036s037,022251s005s006lbl.pdf 10/28/2010
AP010/24/2010SLR26867037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020241s043,s044,020764s036,s037,022251s005,s006ltr.pdf 11/3/2010
AP03/24/2015SLR42272038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,020764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf 3/25/2015
AP03/24/2015SLR42283038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf 3/25/2015
AP08/4/2011SLR29691040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s047,020764s040,022251s010lbl.pdf 8/5/2011
AP08/4/2011SLR29712040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022115s013,020241s047,020764s040,022251s010ltr.pdf 8/8/2011
AP05/31/2011SLR29019041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020241s048,020764s041,022251s011ltr.pdf 6/2/2011
AP011/29/2011SLR30839042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020241s049,020764s042,022251s012,022115s016ltr.pdf 12/2/2011
AP011/29/2011SLR30871042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s049,020764s042,022251s012lbl.pdf 12/2/2011
AP08/1/2012SLR33333043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020241Orig1s050,020764Orig1s043,022251Orig1s013,022115Orig1s017ltr.pdf 8/2/2012
AP08/1/2012SLR33340043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020241s050,020764s043,022251s013lbl.pdf 8/2/2012
AP03/24/2015SLR42273044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,020764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf 3/25/2015
AP03/24/2015SLR42284044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf 3/25/2015
AP06/10/2014SLR39525045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241Orig1s052,020764Orig1s045,022251Orig1s016,022115Orig1s019ltr.pdf 6/12/2014
AP06/10/2014SLR39689045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241Orig1s052,020764Orig1s045,022251Orig1s016Lbl.pdf 6/30/2014
AP05/18/2015SE842844046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022251Orig1s017,020241Orig1s053,020764Orig1s046ltr.pdf 5/20/2015
AP05/18/2015SE842863046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s053,020764s046,022251s017lbl.pdf 5/21/2015




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