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FDA Drug Application 022345 by GLAXOSMITHKLINE

Application Number022345
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/10/2011N29151000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022345s000ltr.pdf 6/15/2011
AP06/10/2011N29182000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022345s000lbl.pdf 6/16/2011
AP06/10/2011N29205000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM259619.pdf 6/17/2011
AP06/10/2011N29467000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022345Orig1s000TOC.cfm 7/11/2011
AP06/10/2011N29468000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022345Orig1s000SumR.pdf 7/11/2011
AP06/10/2011N37665000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm350197.htm 11/1/2013
AP03/19/2012SLR32163001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022345s001lbl.pdf 3/19/2012
AP03/19/2012SLR32169001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022345s001ltr.pdf 3/23/2012
AP011/21/2012SCM       
AP09/6/2013SLR36997006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022345s006lbl.pdf 9/9/2013
AP09/6/2013SLR37042006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022345Orig1s006ltr.pdf 9/11/2013
AP06/6/2013SLR36244007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022345Orig1s007ltr.pdf 6/7/2013
AP06/6/2013SLR36269007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022345s007lbl.pdf 6/11/2013
AP011/25/2015SLR44618009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022345Orig1s009Ltr.pdf 11/27/2015
AP05/26/2015SLR42925010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022345Orig1s010ltr.pdf 5/28/2015
AP05/26/2015SLR42943010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022345s010lbl.pdf 5/29/2015
AP05/20/2016SLR46112011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022345s011lbl.pdf 5/23/2016
AP05/20/2016SLR46116011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022345Orig1s011ltr.pdf 5/24/2016




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