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FDA Drug Application 021330 by GLAXOSMITHKLINE CONS

Application Number021330
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE CONS
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
AP010/31/2002N9597000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-330_Commit.cfm 6/29/2004
AP010/31/2002N2554000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21330ltr.pdf 10/31/2002
AP02/13/2004SCF7750002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21330scf002ltr.pdf 2/27/2004
AP02/13/2004SCF7827002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21330scf002_committ_lbl.pdf 3/3/2004
AP010/25/2005SCP12990003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021330s003lbl.pdf 11/1/2005
AP010/25/2005SCP13011003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021330s003ltr.pdf 11/1/2005
AP011/22/2005SCF13148004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021330s004lbl.pdf 11/30/2005
AP011/22/2005SCF13168004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021330s004ltr.pdf 11/30/2005
AP09/1/2006SCP14814005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021330s005lbl.pdf 9/15/2006
AP09/1/2006SCP14855005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021330s005ltr.pdf 9/18/2006
AP05/23/2008SCF19883007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021330s007ltr.pdf 5/28/2008
AP01/5/2010SLR24519008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021330s008ltr.pdf 1/15/2010
AP08/27/2010SLR26322009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021330s009ltr.pdf 8/31/2010
AP05/23/2012SE832766013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021330s013ltr.pdf 5/29/2012
AP03/8/2013SCM       
AP08/7/2013SLR36729015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021330Orig1s015ltr.pdf 8/8/2013
AP08/7/2013SLR36778015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021330s015lbl.pdf 8/12/2013
AP010/28/2013SLR37602016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021330Orig1s016ltr.pdf 10/29/2013
AP010/28/2013SLR37734016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021330Orig1s016lbl.pdf 11/7/2013
AP08/14/2014SLR40246017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021330Orig1s017ltr.pdf 8/15/2014
AP08/14/2014SLR40313017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021330Orig1s017lbl.pdf 8/25/2014
AP05/18/2015SLR42845018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021330Orig1s018ltr.pdf 5/20/2015
AP05/18/2015SLR42849018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021330Orig1s018lbl.pdf 5/20/2015
AP09/30/2015SLR44092019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021330Orig1s019ltr.pdf 10/2/2015
AP09/30/2015SLR44251019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021330s019lbl.pdf 10/22/2015
AP08/6/2015SLR43602020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021330Orig1s020ltr.pdf 8/10/2015
AP08/6/2015SLR43612020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021330Orig1s020lbl.pdf 8/10/2015




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