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FDA Drug Application 021887 by GLAXOSMITHKLINE CONS

Application Number021887
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE CONS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type OTC (over-the-counter) switch
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/7/2007N15775000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021887lbl.pdf 2/8/2007
AP02/7/2007N15782000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021887s000ltr.pdf 2/12/2007
AP02/7/2007N16208000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021887s000TOC.cfm 4/10/2007
AP09/22/2010SLR26542002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021887s002ltr.pdf 9/27/2010
AP02/4/2011SLR27822004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021887s004ltr.pdf 2/14/2011
AP03/10/2011SLR28236005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021887s005ltr.pdf 3/14/2011
AP06/13/2014SLR39573006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021887Orig1s006ltr.pdf 6/18/2014
AP06/13/2014SLR40136006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021887Orig1s006lbl.pdf 8/5/2014
AP05/25/2016SLR46166008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021887Orig1s008lbl.pdf 5/26/2016
AP05/25/2016SLR46181008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021887Orig1s008ltr.pdf 5/27/2016




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