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FDA Drug Application 021077 by GLAXO GRP LTD

Application Number021077
Application Type New Drug Application
Sponsor ApplicantGLAXO GRP LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/24/2000N6544000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21077_AdvairDiskus.cfm 8/28/2003
AP08/24/2000N13178000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm108111.htm 11/30/2005
AP08/24/2000N23880000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm111326.pdf 11/16/2009
AP012/22/2000SCS       
AP011/17/2003SE16937003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21077se1-003ltr.pdf 11/25/2003
AP011/17/2003SE17037003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21077se1-003_advair_lbl.pdf 12/2/2003
AP011/17/2003SE117931003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021077Orig1S003.pdf 9/24/2007
AP010/16/2001SCS       
AP08/21/2002SLR2644008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21077slr008ltr.pdf 8/21/2002
AP05/17/2002SCS       
AP04/21/2004SE58423017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21077se5-017ltr.pdf 4/29/2004
AP04/21/2004SE58492017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21077se5-017_advair_lbl.pdf 5/4/2004
AP04/21/2004SE534052017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021077Orig1s017.pdf 10/12/2012
AP08/11/2003SLR6501019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21077slr019_advair_lbl.pdf 8/15/2003
AP08/11/2003SLR6524019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21077slr019ltr.pdf 8/15/2003
AP08/11/2003SLR20424019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021077_s019_ADVAIR DISKUS.pdf 8/1/2008
AP09/28/2004SLR10344022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21077s022,20236s030,20692s026ltr.pdf 10/4/2004
AP09/28/2004SLR10349022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021077s022lbl.pdf 10/4/2004
AP09/27/2006SLR15023026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021077s026lbl.pdf 9/28/2006
AP09/27/2006SLR15035026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021077s026LTR.pdf 10/2/2006
AP02/23/2007SLR15916027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021077s027lbl.pdf 2/26/2007
AP02/23/2007SLR15924027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020692s028, 021077s027ltr.pdf 3/1/2007
AP03/2/2006SLR13708028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021077s028lbl.pdf 3/3/2006
AP03/2/2006SLR13828028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021077s028,020692s029ltr.pdf 3/23/2006
AP04/30/2008SE219751029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021077029ltr.pdf 5/1/2008
AP04/30/2008SE219757029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021077s029lbl.pdf 5/2/2008
AP04/30/2008SE220223029   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021077se2-029_SUMR.pdf 7/16/2008
AP03/31/2009SE822197036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021077s036ltr.pdf 4/3/2009
AP01/4/2011SLR27457041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021077s041MedGuide.pdf 1/5/2011
AP01/4/2011SLR27481041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s041ltr.pdf 1/7/2011
AP06/25/2010SLR25828042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021077s042lbl.pdf 6/28/2010
AP06/25/2010SLR25849042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021077s042,021254s013,020692s036ltr.pdf 6/29/2010
AP05/10/2011SLR28789046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s046,021254s015,020692s038ltr.pdf 5/12/2011
AP05/10/2011SLR28821046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021077s046MedG.pdf 5/16/2011
AP06/27/2011SLR29384047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s047,021254s016,020692s039ltr.pdf 7/5/2011
AP08/9/2012SLR       
AP08/9/2012SLR33425049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021077Orig1s049,021254Orig1s019,020692Orig1s042ltr.pdf 8/13/2012
AP06/19/2013SCM36709050   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021077Orig1s050.pdf 8/6/2013
AP04/14/2014SLR39049051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021077Orig1s051ltr.pdf 4/16/2014
AP04/14/2014SLR39052051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021077s051lbl.pdf 4/16/2014
AP04/14/2014SLR44511051   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021077Orig1s051.pdf 11/18/2015
AP06/17/2014SCM46725052   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021077Orig1s052.pdf 8/4/2016
AP011/13/2014SLR40991053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021077Orig1s053ltr.pdf 11/14/2014
AP011/13/2014SLR41344053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021077s053lbl.pdf 12/20/2014
AP04/29/2016S45814054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021077Orig1s054ltr.pdf 5/2/2016
AP04/29/2016S45875054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021077s054lbl.pdf 5/5/2016
AP04/29/2016S46405054Package Labeling  http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021077Orig1s054pkglbl.pdf 6/23/2016




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