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FDA Drug Application 020358 by GLAXOSMITHKLINE

Application Number020358
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
AP010/4/1996N12326000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103318.htm 7/28/2005
AP010/4/1996N24204000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089824.pdf 12/4/2009
AP012/16/1997SLR4354001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020358a_s001_s003.pdf 12/16/1997
AP01/26/1999SLR       
AP012/16/1997SLR4355003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020358a_s001_s003.pdf 12/16/1997
AP011/30/1998SCP       
AP011/30/1998SCS       
AP011/30/1998SCM       
AP04/10/2000SLR       
AP04/10/2000SLR       
AP04/6/1999SCE       
AP04/6/1999SCP       
AP04/6/1999SCM       
AP04/10/2000SLR       
AP04/10/2000SLR       
AP04/10/2000SLR       
AP04/10/2000SLR       
AP04/10/2000SLR       
AP08/4/2000SCS       
AP06/20/2002SLR2834018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644slr024,20358slr024ltr.pdf 10/2/2002
AP06/11/2001SE82841019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20358s19ltr.pdf 6/11/2001
AP06/11/2001SE82842019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20358s19lbl.pdf 6/11/2001
AP06/11/2001SE82843019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-358S019_Bupropion.pdf 6/11/2001
AP010/11/2000SCF30915020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020358Orig1s020_s021_s022.pdf 12/9/2011
AP010/11/2000SCS30916021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020358Orig1s020_s021_s022.pdf 12/9/2011
AP010/11/2000SCM30917022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020358Orig1s020_s021_s022.pdf 12/9/2011
AP06/20/2002SLR2837023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644s022,023and20358s018,023LTR.pdf 6/20/2002
AP010/2/2002SLR2835024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644slr024,20358slr024ltr.pdf 10/2/2002
AP02/13/2002SCM30914025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020358Orig1s025.pdf 12/9/2011
AP07/12/2002SCP       
AP06/14/2002SCM2839027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20358s027ltr.pdf 6/14/2002
AP06/14/2002SCM2840027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20358s27lbl.pdf 6/14/2002
AP06/14/2002SCM16196027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020358_S027_WELLBUTRIN_TABS_AP.pdf 4/9/2007
AP07/12/2002SCM2838028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20358scm028ltr.pdf 7/12/2002
AP010/22/2002SLR2831029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644slr026,20358slr029ltr.pdf 10/22/2002
AP04/26/2004SLR8444030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20358slr030ltr.pdf 4/29/2004
AP05/27/2004SLR8833032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18644slr028,20358slr032,21515slr007ltr.pdf 6/1/2004
AP05/27/2004SLR16864032   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018644s027s028,020358s031s032,021515s006s007_WellbutrinTOC.cfm 6/29/2007
AP01/12/2005SLR10973034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18644s030,20358s034,21515s009,20711s021ltr.pdf 1/13/2005
AP01/12/2005SLR10993034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18644s030,20358s034,21515s009,20711s021lbl.pdf 1/13/2005
AP02/28/2006SLR13720035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021515s012_020358s035_018644s031ltr.pdf 3/3/2006
AP07/3/2006SLR14420037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018644s33s34,020358s37s40,021515s14lbl.pdf 7/5/2006
AP07/3/2006SLR14470037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018644s33,018644s34,020358s37,020358s40,021515s14LTR.pdf 7/13/2006
AP05/17/2011SLR28866039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018644s042,020358s039,s049ltr.pdf 5/19/2011
AP05/17/2011SLR28901039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020358s039s049lbl.pdf 5/23/2011
AP07/3/2006SLR33005040   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020358Orig1s040.pdf 6/26/2012
AP07/3/2006SLR14471040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018644s33,018644s34,020358s37,020358s40,021515s14LTR.pdf 7/13/2006
AP07/3/2006SLR14421040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018644s33s34,020358s37s40,021515s14lbl.pdf 7/5/2006
AP01/29/2007SLR15734042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018644s035,020358s042lbl.pdf 2/2/2007
AP01/29/2007SLR15757042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018644s035, 20358s042ltr.pdf 2/2/2007
AP08/2/2007SLR17493043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020358s043lbl.pdf 8/3/2007
AP08/2/2007SLR17595043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018644s036, 020358s043, 021515s020, 020711s029ltr.pdf 8/7/2007
AP05/25/2010SLR25621045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018644s038,020358s045ltr.pdf 5/27/2010
AP05/25/2010SLR25651045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018644s038,020358s045lbl.pdf 5/28/2010
AP07/1/2009SLR22880046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018644s039,018644s040,020358s046,020358s047ltr.pdf 7/7/2009
AP07/1/2009SLR22874046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020358s046s047lbl.pdf 7/6/2009
AP07/1/2009SLR22875047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020358s046s047lbl.pdf 7/6/2009
AP07/1/2009SLR22881047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018644s039,018644s040,020358s046,020358s047ltr.pdf 7/7/2009
AP02/26/2010SLR24913048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018644s041,020358s048ltr.pdf 3/3/2010
AP02/26/2010SLR24923048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020358s048MedGuide.pdf 3/3/2010
AP05/17/2011SLR28867049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018644s042,020358s039,s049ltr.pdf 5/19/2011
AP05/17/2011SLR28902049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020358s039s049lbl.pdf 5/23/2011
AP07/25/2011SLR29621050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020358s050lbl.pdf 7/25/2011
AP07/25/2011SLR29623050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018644s043,020358s050ltr.pdf 7/28/2011
AP08/2/2012S33362051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018644Orig1s044,020358Orig1s051ltr.pdf 8/3/2012
AP03/19/2013SLR35486052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018644Orig1s045,020358Origs052ltr.pdf 3/21/2013
AP03/19/2013SLR35542052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018644s045,020358s052lbl.pdf 3/26/2013
AP012/23/2013SLR38166053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020358s053s054lbl.pdf 12/24/2013
AP012/23/2013SLR38180053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018644Orig1s046,s047;020358Orig1s053,s054ltr.pdf 12/26/2013
AP012/23/2013SLR39769053   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020358Orig1s053.pdf 7/7/2014
AP012/23/2013SLR39770054   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020358Orig1s054.pdf 7/7/2014
AP012/23/2013SLR38181054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018644Orig1s046,s047;020358Orig1s053,s054ltr.pdf 12/26/2013
AP012/23/2013SLR38167054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020358s053s054lbl.pdf 12/24/2013
AP012/16/2014SLR41284055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018644Orig1s048,020358Orig1s055ltr.pdf 12/17/2014
AP012/16/2014SLR41291055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018644s048,020358s055lbl.pdf 12/17/2014
AP07/17/2014SLR39906056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018644Orig1s049,020358Orig1s056ltr.pdf 7/21/2014
AP07/17/2014SLR39913056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020358s056lbl.pdf 7/22/2014
AP04/25/2016SLR45761057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018644Orig1s050,020358Orig1s057ltr.pdf 4/27/2016
AP04/25/2016SLR45770057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018644s050,020358s057lbl.pdf 4/27/2016




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