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FDA Drug Application 022012 by SMITHKLINE BEECHAM

Application Number022012
Application Type New Drug Application
Sponsor ApplicantSMITHKLINE BEECHAM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative; New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/20/2006N15136000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022012lbl.pdf 10/23/2006
AP010/20/2006N15168000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022012s000ltr.pdf 10/23/2006
AP010/20/2006N17394000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022012s000TOC.cfm 7/27/2007
AP07/16/2007SLR17340001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022012s001ltr.pdf 7/24/2007
AP07/16/2007SLR17358001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022012s001lbl.pdf 7/24/2007
AP08/3/2007SLR17504003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022012s003lbl.pdf 8/6/2007
AP08/3/2007SLR17569003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022012s003ltr.pdf 8/7/2007
AP010/19/2007SLR18254004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022012s004lbl.pdf 10/22/2007
AP010/19/2007SLR18268004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022012s004ltr.pdf 10/22/2007
AP06/23/2009SLR22836010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022012s010s013lbl.pdf 6/29/2009
AP06/23/2009SLR22831010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022012s010,s013ltr.pdf 6/26/2009
AP012/19/2008N21437011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022012s011ltr.pdf 12/31/2008
AP012/19/2008N21503011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022012s011lbl.pdf 1/6/2009
AP06/23/2009SLR22837013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022012s010s013lbl.pdf 6/29/2009
AP06/23/2009SLR22832013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022012s010,s013ltr.pdf 6/26/2009
AP01/25/2011SLR27637016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022012s016lbl.pdf 1/31/2011
AP01/25/2011SLR27669016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s033,022012s016ltr.pdf 2/2/2011
AP01/6/2011SLR27491017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022012s017,s019ltr.pdf 1/7/2011
AP01/6/2011SLR27496017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022012s017s019lbl.pdf 1/10/2011
AP01/6/2011SLR27497019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022012s017s019lbl.pdf 1/10/2011
AP01/6/2011SLR27536019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022012s017,s019ltr.pdf 1/18/2011
AP07/6/2011SLR29447020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020297s036,022012s020ltr.pdf 7/7/2011
AP07/6/2011SLR29449020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022012s020lbl.pdf 7/7/2011
AP010/2/2015SLR44173021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022012s021lbl.pdf 10/8/2015
AP010/2/2015SLR44358021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022012Orig1s021ltr.pdf 11/4/2015




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