Back to FDA Applications sponsored by GLAXOSMITHKLINE

FDA Drug Application 050590 by GLAXOSMITHKLINE

Application Number050590
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/1/1985N       
AP05/13/1985SCS       
AP04/19/1985SCM       
AP04/18/1985SLR       
AP08/12/1985SCS       
AP011/26/1985SCS       
AP011/26/1985SCS       
AP02/14/1986SCS       
AP010/23/1987SE1       
AP08/18/1987SLR       
AP05/16/1988SLR       
AP08/24/1988SCS       
AP04/20/1989SCS       
AP04/20/1989SCS       
AP012/17/1991SE1       
AP02/26/1990SCS       
AP01/2/1992SCS       
AP03/26/1992SLR       
AP03/26/1992SLR       
AP012/1/1987SLR       
AP01/7/1993SLR       
AP06/8/1993SCS       
AP06/8/1993SCM       
AP01/19/1996SLR       
AP09/16/1994SCS       
AP05/17/2002SLR3977027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50590S027ltr.pdf 5/17/2002
AP04/18/1995SCS       
AP02/27/1996SLR       
AP012/11/1997SE5       
AP06/17/1997SCM       
AP07/7/1999SCS       
AP08/29/1997SCP       
AP02/5/1998SCM       
AP02/1/1999SCS       
AP09/23/1999SCS       
AP011/19/1999SCS       
AP03/18/2002SLR3978040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50590s40ltr.pdf 3/18/2002
AP08/2/2001SCS       
AP08/2/2001SCS       
AP08/16/2001SCS       
AP02/8/2002SCM       
AP010/17/2002SCS       
AP01/3/2003SCS       
AP011/19/2004SLR10662052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50590s052,50658s018ltr.pdf 12/2/2004
AP03/15/2007SLR16056054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050590s054,050658s020lbl.pdf 3/16/2007
AP03/15/2007SLR16071054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050590s054,050658s020ltr.pdf 3/23/2007
AP05/8/2008SLR21367055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050590s055, 050658s021ltr.pdf 12/19/2008
AP04/17/2008SLR19692057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050590s057ltr.pdf 4/22/2008
AP04/17/2008SLR19947057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050590s057lbl.pdf 6/5/2008
AP012/20/2010SLR27395058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050658s023,050590s058,050590s059ltr.pdf 12/28/2010
AP012/20/2010SLR27382058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050658s023,050590s058,050590s059lbl.pdf 12/26/2010
AP012/20/2010SLR27383059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050658s023,050590s058,050590s059lbl.pdf 12/26/2010
AP012/20/2010SLR27396059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050658s023,050590s058,050590s059ltr.pdf 12/28/2010
AP06/9/2011SLR29117060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050590s060,s061,050658s024ltr.pdf 6/13/2011
AP06/9/2011SLR29129060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050590s060s061lbl.pdf 6/14/2011
AP06/9/2011SLR29130061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050590s060s061lbl.pdf 6/14/2011
AP06/9/2011SLR29118061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050590s060,s061,050658s024ltr.pdf 6/13/2011
AP010/4/2012SLR33989062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050590s062,050658s025lbl.pdf 10/5/2012
AP010/4/2012SLR33996062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050590Orig1s062,050658Orig1s025ltr.pdf 10/9/2012
AP03/20/2013SCM       
AP07/19/2013SCM       
AP09/27/2013SLR37275067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050590Orig1s067,050658Orig1s029ltr.pdf 10/1/2013
AP09/27/2013SLR37303067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050590s067,050658s029lbl.pdf 10/1/2013
AP02/12/2014SCM       
AP06/12/2014SLR39546069   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050590Orig1s069,050658Orig1s031ltr.pdf 6/17/2014
AP06/12/2014SLR39566069   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050590s069,050658s031lbl.pdf 6/17/2014




Back to FDA Applications sponsored by GLAXOSMITHKLINE

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.