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FDA Drug Application 022122 by GLAXOSMITHKLINE CONS

Application Number022122
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
AP010/17/2007N18258000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022122lbl.pdf 10/22/2007
AP010/17/2007N18280000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/02212s000ltr.pdf 10/22/2007
AP010/17/2007N19250000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/Voltaren_022122.cfm 2/22/2008
AP010/17/2007N19251000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022122_SumR.pdf 2/22/2008
AP010/17/2007N28001000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089822.pdf 3/1/2011
AP09/22/2009SLR23508006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022122s006lbl.pdf 10/1/2009
AP09/22/2009SLR23775006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022122s006ltr.pdf 11/10/2009
AP011/25/2014SLR41109007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022122Orig1s007ltr.pdf 11/28/2014
AP011/25/2014SLR41492007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022122s007lbl.pdf 1/5/2015
AP05/11/2015SCM       
AP05/9/2016SLR45912010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022122Orig1s010ltr.pdf 5/11/2016
AP05/9/2016SLR45975010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022122s010lbl.pdf 5/11/2016
AP09/29/2014SCM       




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