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FDA Drug Application 021254 by GLAXO GRP LTD

Application Number021254
Application Type New Drug Application
Sponsor ApplicantGLAXO GRP LTD
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
AP06/8/2006N14302000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021254lbl.pdf 6/14/2006
AP06/8/2006N14310000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021254s000LTR.pdf 6/14/2006
AP06/8/2006N14318000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm108111.htm 6/19/2006
AP06/8/2006N19768000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021254s000TOC.cfm 5/6/2008
AP06/8/2006N23714000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm111333.pdf 10/30/2009
AP03/20/2008SLR19498003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021254s003,020692s031ltr.pdf 3/21/2008
AP03/20/2008SLR19511003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021254s003,020692s031lbl.pdf 3/24/2008
AP07/31/2008SCS20502004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021254s004ltr.pdf 8/5/2008
AP09/15/2009SLR23426007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021254s007lbl.pdf 9/21/2009
AP09/15/2009SLR23684007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021254s007ltr.pdf 10/26/2009
AP012/19/2012SE834729009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021254Orig1s009ltr.pdf 12/21/2012
AP012/19/2012SE834740009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021254s009lbl.pdf 12/21/2012
AP01/4/2011SLR27458012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021254s012MedG.pdf 1/5/2011
AP01/4/2011SLR27482012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021254s012ltr.pdf 1/7/2011
AP06/25/2010SLR25827013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021254s013lbl.pdf 6/28/2010
AP06/25/2010SLR25850013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021077s042,021254s013,020692s036ltr.pdf 6/29/2010
AP05/10/2011SLR28790015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s046,021254s015,020692s038ltr.pdf 5/12/2011
AP05/10/2011SLR28819015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021077s046,021254s015,020692s038lbl.pdf 5/16/2011
AP05/10/2011SLR28822015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021254s015MedG.pdf 5/16/2011
AP06/27/2011SLR29385016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021077s047,021254s016,020692s039ltr.pdf 7/5/2011
AP08/9/2012SLR       
AP08/9/2012SLR33426019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021077Orig1s049,021254Orig1s019,020692Orig1s042ltr.pdf 8/13/2012
AP06/19/2013SCM       
AP06/17/2014SCM       
AP06/17/2014SCM       
AP011/13/2014SLR41348023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021254s023lbl.pdf 12/20/2014
AP011/13/2014SLR40989023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021254Orig1s023ltr.pdf 11/14/2014
AP012/10/2014SLR41224024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021254s024lbl.pdf 12/11/2014
AP012/10/2014SLR41230024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021254Orig1s024ltr.pdf 12/12/2014




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