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FDA Drug Application 021416 by GLAXOSMITHKLINE LLC

Application Number021416
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
AP09/4/2003N6661000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21416ltr.pdf 9/25/2003
AP09/4/2003N6692000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21416_rythmol_lbl.pdf 9/25/2003
AP09/4/2003N7693000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-416_Rythmol.cfm 2/11/2004
AP09/13/2004SLR10195001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21416s001ltr.pdf 9/15/2004
AP010/29/2010SLR26841007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021416s007lbl.pdf 10/29/2010
AP010/29/2010SLR26883007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021416s007ltr.pdf 11/3/2010
AP04/13/2011SLR28552010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021416s010lbl.pdf 4/15/2011
AP04/13/2011SLR28574010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021416s010ltr.pdf 4/19/2011
AP02/14/2013SLR39599011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021416s011lbl.pdf 6/23/2014
AP09/9/2013SCM       
AP07/11/2014SCM       




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