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FDA Drug Application 022460 by GLAXOSMITHKLINE

Application Number022460
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
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
TA01/20/2010TA25091000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022460s000TAltr.pdf 3/22/2010
TA01/20/2010TA25743000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022460s000lbl.pdf 6/15/2010
TA01/20/2010TA25752000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022460s000ltr.pdf 6/16/2010
TA01/20/2010TA27694000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022460s000_jalyn_toc.cfm 2/3/2011
TA01/20/2010TA27696000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022460Orig1s000SumR.pdf 2/3/2011
TA01/20/2010TA31031000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm258424.htm 12/20/2011
AP16/14/2010N25091000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022460s000TAltr.pdf 3/22/2010
AP16/14/2010N25743000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022460s000lbl.pdf 6/15/2010
AP16/14/2010N25752000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022460s000ltr.pdf 6/16/2010
AP16/14/2010N27694000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022460s000_jalyn_toc.cfm 2/3/2011
AP16/14/2010N27696000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022460Orig1s000SumR.pdf 2/3/2011
AP16/14/2010N31031000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm258424.htm 12/20/2011
AP06/9/2011SLR29098001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022460s001lbl.pdf 6/10/2011
AP06/9/2011SLR29113001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022460s001ltr.pdf 6/13/2011
AP06/27/2012SLR33051002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022460s002lbl.pdf 6/28/2012
AP06/27/2012SLR33055002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022460s002ltr.pdf 6/29/2012
AP04/25/2013SLR35864003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022460s003s004s005lbl.pdf 4/29/2013
AP04/25/2013SLR35874003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022460Orig1s003,s004,s005ltr.pdf 4/30/2013
AP04/25/2013SLR35865004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022460s003s004s005lbl.pdf 4/29/2013
AP04/25/2013SLR35875004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022460Orig1s003,s004,s005ltr.pdf 4/30/2013
AP04/25/2013SLR35866005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022460s003s004s005lbl.pdf 4/29/2013
AP04/25/2013SLR35876005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022460Orig1s003,s004,s005ltr.pdf 4/30/2013
AP06/13/2016SCM       
AP09/13/2016SCM       




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