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FDA Drug Application 020658 by GLAXOSMITHKLINE LLC

Application Number020658
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/19/1997N17293000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020658_requip_toc.cfm 7/17/2007
AP09/19/1997N31046000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm258819.htm 12/20/2011
AP01/27/1999SCM       
AP05/15/2000SLR       
AP08/16/1999SCM       
AP011/2/1999SCP       
AP05/15/2000SLR       
AP03/1/2001SCM       
AP04/3/2001SCS       
AP07/5/2001SCE       
AP010/22/2002SCP       
AP06/19/2003SLR5960012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20658slr012ltr.pdf 6/22/2003
AP06/19/2003SLR14118012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020658_s012_RequipTOC.cfm 5/16/2006
AP05/4/2005SE111609013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020658s013ltr.pdf 5/17/2005
AP05/4/2005SE111638013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020658s013lbl.pdf 5/17/2005
AP05/4/2005SE145093013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020658Orig1s013.pdf 2/3/2016
AP012/31/2008SLR21515018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020658s020,020658s018,020658s021ltr.pdf 1/6/2009
AP012/31/2008SLR21540018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020658s018s020s021lbl.pdf 1/6/2009
AP012/31/2008SLR21516020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020658s020,020658s018,020658s021ltr.pdf 1/6/2009
AP012/31/2008SLR21541020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020658s018s020s021lbl.pdf 1/6/2009
AP012/31/2008SLR21517021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020658s020,020658s018,020658s021ltr.pdf 1/6/2009
AP012/31/2008SLR21542021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020658s018s020s021lbl.pdf 1/6/2009
AP08/28/2014SLR40339024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020658Orig1s024,s026,s027,s030,s032ltr.pdf 9/2/2014
AP08/28/2014SLR40352024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020658s024s026s027s030s032lbl.pdf 9/2/2014
AP08/28/2014SLR40340026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020658Orig1s024,s026,s027,s030,s032ltr.pdf 9/2/2014
AP08/28/2014SLR40353026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020658s024s026s027s030s032lbl.pdf 9/2/2014
AP08/28/2014SLR40341027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020658Orig1s024,s026,s027,s030,s032ltr.pdf 9/2/2014
AP08/28/2014SLR40354027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020658s024s026s027s030s032lbl.pdf 9/2/2014
AP08/28/2014SLR40342030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020658Orig1s024,s026,s027,s030,s032ltr.pdf 9/2/2014
AP08/28/2014SLR40355030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020658s024s026s027s030s032lbl.pdf 9/2/2014
AP03/19/2012SLR32170031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020658s031ltr.pdf 3/23/2012
AP08/28/2014SLR40343032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020658Orig1s024,s026,s027,s030,s032ltr.pdf 9/2/2014
AP08/28/2014SLR40356032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020658s024s026s027s030s032lbl.pdf 9/2/2014
AP09/9/2016SLR47029033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020658s033lbl.pdf 9/12/2016
AP09/9/2016SLR47038033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020658Orig1s033ltr.pdf 9/15/2016




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