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FDA Drug Application 020692 by GLAXOSMITHKLINE

Application Number020692
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
AP09/19/1997N13177000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm108111.htm 11/30/2005
AP09/19/1997N13224000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020692s000_SereventTOC.cfm 12/6/2005
AP09/19/1997N24077000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089125.pdf 11/20/2009
AP09/25/1998SE1594001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20692s1-2ltr.pdf 9/25/1998
AP09/25/1998SE1595001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20692S1,2_Serevent.cfm 9/25/1998
AP09/25/1998SE1596001   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20692s1-2lbl.pdf 9/25/1998
AP09/25/1998SE5624002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20692s1-2ltr.pdf 9/25/1998
AP09/25/1998SE5625002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20692S1,2_Serevent.cfm 9/25/1998
AP09/25/1998SE5626002   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20692s1-2lbl.pdf 9/25/1998
AP03/26/1998SCS       
AP03/18/1998SCS       
AP012/3/1998SCS       
AP03/11/1998SLR       
AP03/18/1998SCS       
AP01/19/2001SCS       
AP07/20/1999SCM       
AP06/29/2000SE8       
AP04/3/2000SCS       
AP06/15/2000SCS       
AP05/17/2001SLR       
AP03/22/2002SE13236016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20692s016ltr.pdf 3/22/2002
AP03/22/2002SE13237016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20692s16lbl.pdf 3/22/2002
AP010/16/2001SCS       
AP05/15/2002SCM       
AP05/17/2002SCS       
AP08/11/2003SLR6506024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20692slr024_serevent_lbl.pdf 8/15/2003
AP08/11/2003SLR6531024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20692slr024ltr.pdf 8/15/2003
AP08/11/2003SLR20405024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020692_s024_SEREVENT DISKUS.pdf 8/1/2008
AP09/28/2004SLR10346026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21077s022,20236s030,20692s026ltr.pdf 10/4/2004
AP09/28/2004SLR10347026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20236s030,20692s026lbl.pdf 10/4/2004
AP02/23/2007SLR15917028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020692s028lbl.pdf 2/26/2007
AP02/23/2007SLR15923028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020692s028, 021077s027ltr.pdf 3/1/2007
AP03/2/2006SLR13706029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020692s029lbl.pdf 3/3/2006
AP03/2/2006SLR13827029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021077s028,020692s029ltr.pdf 3/23/2006
AP03/20/2008SLR19499031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021254s003,020692s031ltr.pdf 3/21/2008
AP03/20/2008SLR19512031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021254s003,020692s031lbl.pdf 3/24/2008
AP012/30/2010SLR27435032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020692s032lbl.pdf 1/4/2011
AP012/30/2010SLR27441032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020692s032ltr.pdf 1/4/2011
AP011/18/2010SLR27005035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020692s035ltr.pdf 11/22/2010
AP06/25/2010SLR25826036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020692s036lbl.pdf 6/28/2010
AP06/25/2010SLR25851036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021077s042,021254s013,020692s036ltr.pdf 6/29/2010
AP05/10/2011SLR28791038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s046,021254s015,020692s038ltr.pdf 5/12/2011
AP05/10/2011SLR28818038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021077s046,021254s015,020692s038lbl.pdf 5/16/2011
AP05/10/2011SLR28823038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020692s038MedG.pdf 5/16/2011
AP06/27/2011SLR29386039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s047,021254s016,020692s039ltr.pdf 7/5/2011
AP08/9/2012SLR       
AP08/9/2012SLR33427042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021077Orig1s049,021254Orig1s019,020692Orig1s042ltr.pdf 8/13/2012
AP04/14/2014SLR39044043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020692Orig1s043ltr.pdf 4/16/2014
AP04/14/2014SLR39054043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020692s043lbl.pdf 4/16/2014
AP06/17/2016SCM       
AP09/30/2016SLR47278045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020692Orig1s045ltr.pdf 10/5/2016
AP09/30/2016SLR47306045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020692s045lbl.pdf 10/6/2016




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