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FDA Drug Application 021438 by GLAXOSMITHKLINE LLC

Application Number021438
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE LLC
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
AP03/12/2003N5287000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21438ltr.pdf 4/15/2003
AP03/12/2003N6099000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-438_Innopran.cfm 7/8/2003
AP03/12/2003N9123000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-438_Innopran_prntlbl.pdf 6/7/2004
AP010/22/2004SLR10497005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21438s005ltr.pdf 10/29/2004
AP01/2/2008SLR18729011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021438s011lbl.pdf 1/8/2008
AP01/2/2008SLR18791011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021438s01ltr_rc.pdf 1/9/2008
AP012/30/2009SLR24428012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021438s012ltr.pdf 1/5/2010
AP012/30/2009SLR24492012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021438s012lbl.pdf 1/12/2010
AP012/14/2010SLR27296013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021438s013s014lbl.pdf 12/16/2010
AP012/14/2010SLR27304013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021438s013,s014ltr.pdf 12/21/2010
AP012/14/2010SLR27305014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021438s013,s014ltr.pdf 12/21/2010
AP012/14/2010SLR27297014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021438s013s014lbl.pdf 12/16/2010
AP011/19/2013SLR37866016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021438Orig1s016ltr.pdf 11/20/2013
AP011/19/2013SLR37891016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021438s016lbl.pdf 11/22/2013
AP010/24/2013SCM       




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