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FDA Drug Application 020241 by GLAXOSMITHKLINE LLC

Application Number020241
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/27/1994N23455000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM152835.pdf 9/25/2009
AP08/24/1998SE1225002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20241s2ltr.pdf 8/24/1998
AP08/24/1998SE1226002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020764a.cfm 5/20/1999
AP08/24/1998SE1227002   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20241s2lbl.pdf 8/24/1998
AP012/14/1998SE1373003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20241s3ltr.pdf 12/14/1998
AP012/14/1998SE1374003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020241s003.cfm 6/30/1999
AP012/14/1998SE1375003   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20241s03lbl.pdf 12/14/1998
AP03/11/1997SLR       
AP03/16/1998SCS       
AP03/16/1998SLR       
AP05/10/1999SCM       
AP01/17/2003SE14204008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020241s008lbl.pdf 3/6/2003
AP06/8/1999SCM       
AP09/22/2006SE114974010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241s10s21s25s26s27,020764s3s14s18s19s20lbl.pdf 9/25/2006
AP19/25/2006SLR14974010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241s10s21s25s26s27,020764s3s14s18s19s20lbl.pdf 9/25/2006
AP09/22/2006SE114990010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf 9/26/2006
AP19/25/2006SLR14990010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf 9/26/2006
AP09/22/2006SE115009010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf 9/27/2006
AP19/25/2006SLR15009010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf 9/27/2006
AP05/25/2001SE82765011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20764s5lbl.pdf 5/25/2001
AP05/25/2001SE813231011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020241_S011.pdf 12/8/2005
AP06/12/2000SCM       
AP09/8/2000SLR       
AP02/23/2001SLR       
AP01/14/2004SE87586016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20241se8-016,20764se8-009ltr.pdf 1/22/2004
AP06/20/2003SE16048017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20241se1-017,20764se1-011ltr.pdf 7/6/2003
AP06/20/2003SE16071017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20241se1-017,20764se1-011_lamictal_lbl.pdf 7/8/2003
AP06/20/2003SE116652017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020241_S017_020764_S011TOC.cfm 5/29/2007
AP04/4/2003SLR5375018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20241slr018ltr.pdf 4/18/2003
AP19/25/2006SLR36962021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf 9/6/2013
AP19/25/2006SLR36963021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241s10s21s25s26s27,020764s3s14s18s19s20lbl.pdf 9/6/2013
AP09/25/2006SLR36964025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf 9/6/2013
AP09/25/2006SLR36965025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241SLRs10s21s25s26s27,020764SLRs3s14s18s19s20lbl.pdf 9/6/2013
AP09/25/2006SLR36966026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf 9/6/2013
AP09/25/2006SLR36967026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241s10s21s25s26s27,020764s3s14s18s19s20lbl.pdf 9/6/2013
AP09/22/2006SE136968027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020241s10,s21,s25,s27,020764s3,s14,s18,s19,s20LTR.pdf 9/6/2013
AP09/22/2006SE136969027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020241s10s21s25s26s27,020764s3s14s18s19s20lbl.pdf 9/6/2013
AP09/22/2006SE136970027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020764_s020_Lamictal-optimized.pdf 9/6/2013
AP03/17/2006SLR       
AP012/30/2014SLR41479035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s033,022251s002s009lbl.pdf 1/5/2015
AP012/30/2014SLR41503035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s028s033,022115s004s014,022251s002s009ltr.pdf 1/7/2015
AP05/8/2009SLR22572036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020241s036,020764s029ltr.pdf 5/13/2009
AP05/8/2009SLR22892036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022251,020764s029,020241s036lbl.pdf 7/8/2009
AP04/23/2009SLR22530037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020241s037s038,020764s030s031lbl.pdf 5/12/2009
AP04/23/2009SLR22386037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020241s037,s038,020764s030,s031ltr.pdf 5/4/2009
AP04/23/2009SLR22387038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020241s037,s038,020764s030,s031ltr.pdf 5/4/2009
AP04/23/2009SLR22531038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020241s037s038,020764s030s031lbl.pdf 5/12/2009
AP012/20/2013SLR38143039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020241s039,020764s032,022251s001lbl.pdf 12/23/2013
AP012/20/2013SLR38174039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020241Orig1s039;020764Orig1s032;022251Orig1s001;022115Orig1s003ltr.pdf 12/26/2013
AP012/30/2014SLR41480040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241s035s040,020764s028s033,022251s002s009lbl.pdf 1/5/2015
AP012/30/2014SLR41504040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241s035s040,020764s028s033,022115s004s014,022251s002s009ltr.pdf 1/7/2015
AP010/24/2010SLR26792043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020241s043s044,020764s036s037,022251s005s006lbl.pdf 10/28/2010
AP010/24/2010SLR26864043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020241s043,s044,020764s036,s037,022251s005,s006ltr.pdf 11/3/2010
AP010/24/2010SLR29693044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020241s043,s044,020764s036,s037,022251s005,s006ltr.pdf 11/3/2010
AP010/24/2010SLR29694044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020241s043s044,020764s036s037,022251s005s006lbl.pdf 10/28/2010
AP03/24/2015SLR42270045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,020764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf 3/25/2015
AP03/24/2015SLR42281045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf 3/25/2015
AP08/4/2011SLR29710047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022115s013,020241s047,020764s040,022251s010ltr.pdf 8/8/2011
AP08/4/2011SLR29690047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s047,020764s040,022251s010lbl.pdf 8/5/2011
AP05/31/2011SLR29018048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020241s048,020764s041,022251s011ltr.pdf 6/2/2011
AP011/29/2011SLR30838049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020241s049,020764s042,022251s012,022115s016ltr.pdf 12/2/2011
AP011/29/2011SLR30872049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020241s049,020764s042,022251s012lbl.pdf 12/2/2011
AP08/1/2012SLR33336050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020241Orig1s050,020764Orig1s043,022251Orig1s013,022115Orig1s017ltr.pdf 8/2/2012
AP08/1/2012SLR33341050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020241s050,020764s043,022251s013lbl.pdf 8/2/2012
AP03/24/2015SLR42282051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf 3/25/2015
AP03/24/2015SLR42271051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020241Orig1s045,051,020764Orig1s038,044,022251Orig1s007,014,022115Orig1s011,018ltr.pdf 3/25/2015
AP06/10/2014SLR39524052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020241Orig1s052,020764Orig1s045,022251Orig1s016,022115Orig1s019ltr.pdf 6/12/2014
AP06/10/2014SLR39688052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020241Orig1s052,020764Orig1s045,022251Orig1s016Lbl.pdf 6/30/2014
AP05/18/2015SE842843053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022251Orig1s017,020241Orig1s053,020764Orig1s046ltr.pdf 5/20/2015
AP05/18/2015SE842862053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s053,020764s046,022251s017lbl.pdf 5/21/2015




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