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FDA Drug Application 050658 by GLAXOSMITHKLINE

Application Number050658
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
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
AP012/15/1989N       
AP012/22/1992SCS       
AP01/19/1996SLR       
AP09/15/1994SCS       
AP02/27/1996SLR       
AP02/1/1999SCS       
AP09/23/1999SCS       
AP011/19/1999SCS       
AP03/18/2002SLR3979009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50590s40ltr.pdf 3/18/2002
AP08/2/2001SCS       
AP09/17/2001SCS       
AP02/8/2002SCM       
AP010/17/2002SCS       
AP01/3/2003SCS       
AP011/19/2004SLR10663018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50590s052,50658s018ltr.pdf 12/2/2004
AP03/15/2007SLR16057020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050590s054,050658s020lbl.pdf 3/16/2007
AP03/15/2007SLR16070020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050590s054,050658s020ltr.pdf 3/23/2007
AP05/8/2008SLR21368021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050590s055, 050658s021ltr.pdf 12/19/2008
AP04/17/2008SLR19694022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050658s022ltr.pdf 4/22/2008
AP04/17/2008SLR19939022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050658s022lbl.pdf 6/5/2008
AP012/20/2010SLR27384023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050658s023,050590s058,050590s059lbl.pdf 12/26/2010
AP012/20/2010SLR27394023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050658s023,050590s058,050590s059ltr.pdf 12/28/2010
AP06/9/2011SLR29119024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050590s060,s061,050658s024ltr.pdf 6/13/2011
AP06/9/2011SLR29131024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050658s024lbl.pdf 6/14/2011
AP010/4/2012SLR33990025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050590s062,050658s025lbl.pdf 10/5/2012
AP010/4/2012SLR33997025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050590Orig1s062,050658Orig1s025ltr.pdf 10/9/2012
AP05/29/2013SCM       
AP09/27/2013SLR37276029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050590Orig1s067,050658Orig1s029ltr.pdf 10/1/2013
AP09/27/2013SLR37302029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050590s067,050658s029lbl.pdf 10/1/2013
AP05/14/2014SCM       
AP06/12/2014SLR39547031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050590Orig1s069,050658Orig1s031ltr.pdf 6/17/2014
AP06/12/2014SLR39567031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050590s069,050658s031lbl.pdf 6/17/2014




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