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FDA Drug Application 022327 by GLAXOSMITHKLINE CONS

Application Number022327
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE CONS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/18/2009N22601000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022327s000ltr.pdf 5/22/2009
AP05/18/2009N23109000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022327_prevacid_24hr_toc.cfm 8/3/2009
AP05/18/2009N23110000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022327s000_SumR.pdf 8/3/2009
AP05/18/2009N31073000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 12/20/2011
AP09/15/2010SLR26501004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022327s004ltr.pdf 9/20/2010
AP012/1/2010SLR27191008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022327s008ltr.pdf 12/6/2010
AP012/1/2010SLR37918008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022327Orig1s008lbl.pdf 11/26/2013
AP01/26/2011SLR27192009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022327s009ltr.pdf 12/6/2010
AP01/26/2011SLR37924009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022327Orig1s009lbl.pdf 11/26/2013
AP04/19/2011SLR28587013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022327s013ltr.pdf 4/20/2011
AP04/19/2011SLR37923013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022327Orig1s013lbl.pdf 11/26/2013
AP09/27/2011SLR30138016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022327s016ltr.pdf 9/29/2011
AP09/27/2011SLR37922016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022327Orig1s016lbl.pdf 11/26/2013
AP010/31/2011SLR30458017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022327s017ltr.pdf 11/2/2011
AP010/31/2011SLR37921017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022327Orig1s017lbl.pdf 11/26/2013
AP04/5/2012SLR32367018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022327s018ltr.pdf 4/9/2012
AP04/5/2012SLR37920018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022327Orig1s018lbl.pdf 11/26/2013
AP04/23/2012SLR32534019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022327s019ltr.pdf 4/25/2012
AP04/23/2012SLR37847019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022327Orig1s019lbl.pdf 11/19/2013
AP09/19/2012SLR33818020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022327Orig1s020ltr.pdf 9/24/2012
AP09/19/2012SLR37919020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022327Orig1s020lbl.pdf 11/26/2013
AP06/12/2013SCM       
AP06/30/2015SLR43222022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022327Orig1s022lbl.pdf 7/2/2015
AP06/30/2015SLR43282022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022327Orig1s022ltr.pdf 7/9/2015




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