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FDA Drug Application 022008 by GLAXOSMITHKLINE LLC

Application Number022008
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE LLC
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
AP06/13/2008N20046000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022008s000ltr.pdf 6/20/2008
AP06/13/2008N20157000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022008s000ltr_FINAL.pdf 7/8/2008
AP06/13/2008N20171000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022008lbl.pdf 7/9/2008
AP06/13/2008N21413000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022008_requip_toc.cfm 12/29/2008
AP17/1/2008N20046000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022008s000ltr.pdf 6/20/2008
AP17/1/2008N20157000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022008s000ltr_FINAL.pdf 7/8/2008
AP17/1/2008N20171000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022008lbl.pdf 7/9/2008
AP17/1/2008N21413000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022008_requip_toc.cfm 12/29/2008
AP010/31/2008SCF21131001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022008s001ltr.pdf 11/3/2008
AP010/31/2008SCF21189001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022008s001lbl.pdf 11/7/2008
AP04/10/2009SCF22277002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022008s002lbl.pdf 4/16/2009
AP04/10/2009SCF22284002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022008s002ltr.pdf 4/16/2009
AP08/28/2014SLR40344003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022008Orig1s003,s004,s007,s008replacement_ltr.pdf 9/2/2014
AP08/28/2014SLR40384003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022008s003s004s007s008lbledt.pdf 9/3/2014
AP08/28/2014SLR40345004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022008Orig1s003,s004,s007,s008replacement_ltr.pdf 9/2/2014
AP08/28/2014SLR40385004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022008s003s004s007s008lbledt.pdf 9/3/2014
AP08/28/2014SLR40346007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022008Orig1s003,s004,s007,s008replacement_ltr.pdf 9/2/2014
AP08/28/2014SLR40386007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022008s003s004s007s008lbledt.pdf 9/3/2014
AP08/28/2014SLR40347008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022008Orig1s003,s004,s007,s008replacement_ltr.pdf 9/2/2014
AP08/28/2014SLR40387008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022008s003s004s007s008lbledt.pdf 9/3/2014




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