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FDA Drug Application 018644 by GLAXOSMITHKLINE

Application Number018644
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
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
AP012/30/1985N12325000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103318.htm 7/28/2005
AP012/30/1985N24203000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089824.pdf 12/4/2009
AP02/11/1986SLR       
AP02/11/1986SLR       
AP05/30/1989SCS       
AP06/24/1991SCP       
AP03/23/1994SCF       
AP03/23/1994SCS       
AP03/23/1994SCP       
AP06/24/1991SLR       
AP011/27/1995SLR5925010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018644a_s010_s012_s013.pdf 6/17/2003
AP011/27/1995SLR5926012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018644a_s010_s012_s013.pdf 6/17/2003
AP010/31/1996SCS5927013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/018644a_s010_s012_s013.pdf 6/17/2003
AP04/10/2000SLR       
AP04/10/2000SLR       
AP04/10/2000SLR       
AP04/10/2000SLR       
AP04/10/2000SLR       
AP04/10/2000SLR       
AP04/10/2000SLR       
AP04/10/2000SLR       
AP06/20/2002SLR2832022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644slr024,20358slr024ltr.pdf 10/2/2002
AP06/20/2002SLR2836023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644s022,023and20358s018,023LTR.pdf 6/20/2002
AP010/2/2002SLR2833024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644slr024,20358slr024ltr.pdf 10/2/2002
AP02/13/2002SCM2844025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644s25ltr.pdf 2/12/2002
AP010/22/2002SLR2830026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18644slr026,20358slr029ltr.pdf 10/22/2002
AP05/27/2004SLR8832028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18644slr028,20358slr032,21515slr007ltr.pdf 6/1/2004
AP05/27/2004SLR16865028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018644s027s028,020358s031s032,021515s006s007_WellbutrinTOC.cfm 6/29/2007
AP01/12/2005SLR10972030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18644s030,20358s034,21515s009,20711s021ltr.pdf 1/13/2005
AP01/12/2005SLR10992030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18644s030,20358s034,21515s009,20711s021lbl.pdf 1/13/2005
AP02/28/2006SLR13719031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021515s012_020358s035_018644s031ltr.pdf 3/3/2006
AP07/3/2006SLR14419033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018644s33s34,020358s37s40,021515s14lbl.pdf 7/5/2006
AP07/3/2006SLR14472033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018644s33,018644s34,020358s37,020358s40,021515s14LTR.pdf 7/13/2006
AP07/3/2006SLR14422034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018644s33s34,020358s37s40,021515s14lbl.pdf 7/5/2006
AP07/3/2006SLR14473034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018644s33,018644s34,020358s37,020358s40,021515s14LTR.pdf 7/13/2006
AP07/3/2006SLR33004034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/018644Orig1s034.pdf 6/26/2012
AP01/29/2007SLR15758035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018644s035, 20358s042ltr.pdf 2/2/2007
AP08/2/2007SLR17492036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018644s036lbl.pdf 8/3/2007
AP08/2/2007SLR17596036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018644s036, 020358s043, 021515s020, 020711s029ltr.pdf 8/7/2007
AP05/25/2010SLR25620038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018644s038,020358s045ltr.pdf 5/27/2010
AP05/25/2010SLR25652038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018644s038,020358s045lbl.pdf 5/28/2010
AP07/1/2009SLR22876039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018644s039s040.pdf 7/6/2009
AP07/1/2009SLR22878039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018644s039,018644s040,020358s046,020358s047ltr.pdf 7/7/2009
AP07/1/2009SLR22877040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018644s039s040.pdf 7/6/2009
AP07/1/2009SLR22879040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018644s039,018644s040,020358s046,020358s047ltr.pdf 7/7/2009
AP02/26/2010SLR24912041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018644s041,020358s048ltr.pdf 3/3/2010
AP02/26/2010SLR24924041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018644s041MedGuide.pdf 3/3/2010
AP05/17/2011SLR28865042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018644s042,020358s039,s049ltr.pdf 5/19/2011
AP05/17/2011SLR28900042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018644s042lbl.pdf 5/23/2011
AP07/25/2011SLR29620043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018644s043lbl.pdf 7/25/2011
AP07/25/2011SLR29622043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018644s043,020358s050ltr.pdf 7/28/2011
AP08/2/2012S33361044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018644Orig1s044,020358Orig1s051ltr.pdf 8/3/2012
AP03/19/2013SLR35485045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018644Orig1s045,020358Origs052ltr.pdf 3/21/2013
AP03/19/2013SLR35543045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018644s045,020358s052lbl.pdf 3/26/2013
AP012/23/2013SLR38165046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018644s046s047lbl.pdf 12/24/2013
AP012/23/2013SLR38178046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018644Orig1s046,s047;020358Orig1s053,s054ltr.pdf 12/26/2013
AP012/23/2013SLR39767046   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/018644Orig1s046.pdf 7/7/2014
AP012/23/2013SLR38164047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018644s046s047lbl.pdf 12/24/2013
AP012/23/2013SLR38179047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018644Orig1s046,s047;020358Orig1s053,s054ltr.pdf 12/26/2013
AP012/23/2013SLR39768047   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/018644Orig1s047.pdf 7/7/2014
AP012/16/2014SLR41283048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018644Orig1s048,020358Orig1s055ltr.pdf 12/17/2014
AP012/16/2014SLR41290048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018644s048,020358s055lbl.pdf 12/17/2014
AP07/17/2014SLR39905049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018644Orig1s049,020358Orig1s056ltr.pdf 7/21/2014
AP07/17/2014SLR39912049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018644s049lbl.pdf 7/22/2014
AP04/25/2016SLR45760050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018644Orig1s050,020358Orig1s057ltr.pdf 4/27/2016
AP04/25/2016SLR45769050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018644s050,020358s057lbl.pdf 4/27/2016




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