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FDA Drug Application 021036 by GLAXOSMITHKLINE

Application Number021036
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
AP07/26/1999N991000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21036ltr.pdf 7/26/1999
AP07/26/1999N992000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21036.cfm 7/26/1999
AP07/26/1999N993000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21036lbl.pdf 7/26/1999
AP04/26/2000SE11447001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21036S1LTR.PDF 4/26/2000
AP04/26/2000SE11448001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21036S1LBL.PDF 4/26/2000
AP04/26/2000SE18325001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-036-s001_Relenza.cfm 4/12/2004
AP05/18/2001SCS       
AP04/27/2001SLR5593004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21036S4lbl.pdf 4/27/2001
AP08/5/2003SLR6733005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021036s005lbl.pdf 10/7/2003
AP08/5/2003SLR9364005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21036slr005ltr.pdf 6/15/2004
AP08/6/2003SLR6504006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21036slr006_relenza_lbl.pdf 8/15/2003
AP08/6/2003SLR6527006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21036slr006ltr.pdf 8/15/2003
AP03/25/2004SLR23602007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021036s007ltr.pdf 10/16/2009
AP03/29/2006SE113839008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021036s008lbl.pdf 4/3/2006
AP03/29/2006SE113849008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021036s008ltr.pdf 4/5/2006
AP03/29/2006SE138301008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021036Orig1s008.pdf 1/16/2014
AP011/22/2006SLR23603010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021036s010ltr.pdf 10/16/2009
AP09/7/2007SLR17830012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021036s012lbl.pdf 9/11/2007
AP09/7/2007SLR17852012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021036s012ltr.pdf 9/11/2007
AP03/9/2007SLR16030013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021036s013ltr.pdf 3/15/2007
AP06/27/2007SCB23604014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021036s014ltr.pdf 10/16/2009
AP012/13/2007SO23605015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021036s015ltr.pdf 10/16/2009
AP02/21/2008SLR19267016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021036s016lbl.pdf 2/25/2008
AP02/21/2008SLR19285016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021036s016ltr.pdf 2/25/2008
AP010/2/2008SLR20967017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021036s017ltr.pdf 10/7/2008
AP010/2/2008SLR21001017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021036s017lbl.pdf 10/9/2008
AP05/8/2009SCE23606018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021036s018ltr.pdf 10/16/2009
AP03/24/2010SLR25124019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021036s019lbl.pdf 3/26/2010
AP03/24/2010SLR25135019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021036s019ltr.pdf 3/29/2010
AP05/4/2010SLR25479024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021036s024ltr.pdf 5/7/2010
AP012/9/2010SLR27270025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021036s025lbl.pdf 12/10/2010
AP012/9/2010SLR27282025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021036s025ltr.pdf 12/15/2010
AP012/20/2011SLR31221027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021036s027ltr.pdf 12/22/2011
AP012/20/2011SLR31231027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021036s027lbl.pdf 12/23/2011
AP02/15/2013SCM       
AP12/15/2013SCM       
AP07/21/2016SCM       




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