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FDA Drug Application 020711 by GLAXOSMITHKLINE

Application Number020711
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
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
AP05/14/1997N6451000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020711_zyban_toc.cfm 8/8/2003
AP05/14/1997N12327000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103318.htm 7/28/2005
AP05/14/1997N24209000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089835.pdf 12/4/2009
AP05/14/1997N34606000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=73 12/12/2012
AP09/10/1999SE4       
AP02/24/1999SLR14119002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020711_s002s004_ZybanTOC.cfm 5/16/2006
AP09/10/1999SE2       
AP02/24/1999SLR14120004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020711_s002s004_ZybanTOC.cfm 5/16/2006
AP03/5/1999SLR       
AP04/7/1999SCP       
AP03/5/1999SLR       
AP011/28/2000SLR       
AP011/28/2000SLR       
AP011/28/2000SLR       
AP08/3/2000SCS       
AP02/7/2001SE82232012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-711SE8-012_Zyban_Approv.pdf 2/7/2001
AP02/7/2001SE82233012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20711s12lbl.pdf 2/7/2001
AP02/7/2001SE82234012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-711s12_Zyban.cfm 2/7/2001
AP02/14/2003SLR9671013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20711slr013,014,016,018ltr.pdf 7/1/2004
AP02/14/2003SLR9676013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20711slr013,014,016,018_zyban_lbl.pdf 7/1/2004
AP02/14/2003SLR9677014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20711slr013,014,016,018_zyban_lbl.pdf 7/1/2004
AP02/14/2003SLR9672014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20711slr013,014,016,018ltr.pdf 7/1/2004
AP02/21/2002SLR17234015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020711_S015_ZYBAN.pdf 7/9/2007
AP02/21/2002SLR2214015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20711s15ltr.pdf 2/21/2002
AP02/14/2003SLR9673016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20711slr013,014,016,018ltr.pdf 7/1/2004
AP02/14/2003SLR9678016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20711slr013,014,016,018_zyban_lbl.pdf 7/1/2004
AP02/15/2002SCM       
AP02/14/2003SLR9674018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20711slr013,014,016,018ltr.pdf 7/1/2004
AP02/14/2003SLR9675018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20711slr013,014,016,018_zyban_lbl.pdf 7/1/2004
AP011/3/2004SLR10547019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20711s019,020ltr.pdf 11/8/2004
AP011/3/2004SLR10561019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20711s019,020lbl.pdf 11/8/2004
AP011/3/2004SLR10562020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20711s019,020lbl.pdf 11/8/2004
AP011/3/2004SLR10548020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20711s019,020ltr.pdf 11/8/2004
AP01/12/2005SLR10975021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18644s030,20358s034,21515s009,20711s021ltr.pdf 1/13/2005
AP01/12/2005SLR10995021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18644s030,20358s034,21515s009,20711s021lbl.pdf 1/13/2005
AP03/13/2006SLR13882022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020711s022ltr.pdf 4/7/2006
AP04/28/2006SLR14041024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020711s024LTR.pdf 5/2/2006
AP08/22/2011SLR29872026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020711s026lbl.pdf 8/22/2011
AP08/22/2011SLR29887026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020711s026,s035ltr.pdf 8/26/2011
AP011/16/2006SLR15377027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020711s027lbl.pdf 11/22/2006
AP011/16/2006SLR15386027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020711s027ltr.pdf 11/22/2006
AP03/22/2007SLR16085028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020711s028ltr.pdf 3/23/2007
AP03/22/2007SLR16086028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020711s028lbl.pdf 3/23/2007
AP08/2/2007SLR17495029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020711s029lbl.pdf 8/3/2007
AP08/2/2007SLR17593029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018644s036, 020358s043, 021515s020, 020711s029ltr.pdf 8/7/2007
AP09/20/2010SLR26523031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/0020711s031lbl.pdf 9/20/2010
AP09/20/2010SLR26530031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020711s031ltr.pdf 9/23/2010
AP07/1/2009SLR22927032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020711s032s033lbl.pdf 7/9/2009
AP07/1/2009SLR22895032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020711s032,s033ltr.pdf 7/8/2009
AP07/1/2009SLR22896033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020711s032,s033ltr.pdf 7/8/2009
AP07/1/2009SLR22928033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020711s032s033lbl.pdf 7/9/2009
AP02/26/2010SLR24916034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020711s034ltr.pdf 3/3/2010
AP08/22/2011SLR29873035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020711s035lbl.pdf 8/22/2011
AP08/22/2011SLR29888035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020711s026,s035ltr.pdf 8/26/2011
AP01/18/2012SLR31418036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020711s036ltr.pdf 1/20/2012
AP01/18/2012SLR31630036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020711s036lbl.pdf 2/1/2012
AP03/27/2014SLR38922039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020711Orig1s039ltr.pdf 3/28/2014
AP03/27/2014SLR38948039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020711s039lbl.pdf 4/1/2014
AP012/24/2014SLR41452042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020711Orig1s042ltr.pdf 12/30/2014
AP012/24/2014SLR41601042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020711s042lbl.pdf 1/9/2015
AP08/13/2014SLR40236043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020711Orig1s043ltr.pdf 8/14/2014
AP08/13/2014SLR40252043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020711s043lbl.pdf 8/15/2014
AP06/1/2016SLR46238044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020711Orig1s044ltr.pdf 6/2/2016
AP06/1/2016SLR46245044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020711s044lbl.pdf 6/2/2016




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