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FDA Drug Application 021928 by PFIZER INC

Application Number021928
Application Type New Drug Application
Sponsor ApplicantPFIZER INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/10/2006N14101000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021928lbl.pdf 5/16/2006
AP05/10/2006N14105000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021928s000ltr.pdf 5/16/2006
AP05/10/2006N14314000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021928_s000_ChantixTOC.cfm 6/16/2006
AP05/10/2006N14783000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106540.htm 9/1/2006
AP05/10/2006N22660000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088569.pdf 5/29/2009
AP05/10/2006N43195000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=12 7/2/2015
AP011/20/2007SLR18583003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021928s003ltr.pdf 11/26/2007
AP011/20/2007SLR18589003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021928s003lbl.pdf 11/26/2007
AP01/31/2008SLR19035007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021928s007lbl.pdf 2/1/2008
AP01/31/2008SLR19051007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021928s007ltr.pdf 2/4/2008
AP05/16/2008SLR19845008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021928s008lbl.pdf 5/16/2008
AP05/16/2008SLR19859008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021928s008ltr.pdf 5/21/2008
AP010/19/2009SLR23653011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021928s011lbl.pdf 10/21/2009
AP010/19/2009SLR24128011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021928s011ltr.pdf 11/24/2009
AP07/1/2009SLR22903012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021928s012,s013ltr.pdf 7/8/2009
AP07/1/2009SLR22920012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021928s012s013lbl.pdf 7/9/2009
AP07/1/2009SLR22921013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021928s012s013lbl.pdf 7/9/2009
AP07/1/2009SLR24137013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021928s012,s013ltr.pdf 11/25/2009
AP04/22/2010SLR25345014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021928s014,021928s017ltr.pdf 4/27/2010
AP04/22/2010SLR25430014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021928s014s017lbl.pdf 5/3/2010
AP02/4/2010SLR24791015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021928s015ltr.pdf 2/17/2010
AP04/22/2010SLR25346017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021928s014,021928s017ltr.pdf 4/27/2010
AP04/22/2010SLR25429017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021928s014s017lbl.pdf 5/3/2010
AP02/17/2011SLR27967018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021928s018ltr.pdf 2/24/2011
AP07/22/2011SE829576019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021928Orig1s019s020s021ltr.pdf 7/22/2011
AP07/22/2011SE829582019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021928s019s020s021lbl.pdf 7/22/2011
AP07/22/2011SE829583020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021928s019s020s021lbl.pdf 7/22/2011
AP07/22/2011SE829577020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021928Orig1s019s020s021ltr.pdf 7/22/2011
AP07/22/2011SE829578021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021928Orig1s019s020s021ltr.pdf 7/22/2011
AP07/22/2011SE829584021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021928s019s020s021lbl.pdf 7/22/2011
AP012/17/2010SLR27331023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021928s023ltr.pdf 12/22/2010
AP012/17/2010SLR27346023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021928s023lbl.pdf 12/22/2010
AP06/29/2011SLR29401024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021928s024ltr.pdf 7/6/2011
AP011/9/2011SLR30550025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021928s025lbl.pdf 11/10/2011
AP011/9/2011SLR30559025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021928s025ltr.pdf 11/14/2011
AP01/20/2012SLR31502028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021928s028lbl.pdf 1/24/2012
AP01/20/2012SLR31507028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021928s028ltr.pdf 1/25/2012
AP02/19/2013SE835220030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021928s030lbl.pdf 2/21/2013
AP02/19/2013SE835458030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021928Orig1s030ltr_repl.pdf 3/15/2013
AP012/11/2012SE834628031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021928s031lbl.pdf 12/13/2012
AP012/11/2012SE834658031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021928Orig1s031ltr.pdf 12/13/2012
AP09/19/2014SE840547032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s032s036s038lbl.pdf 9/22/2014
AP09/19/2014SE840583032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021928Orig1s032,s036,s038ltr.pdf 9/24/2014
AP010/15/2014SE840796033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021928Orig1s033,s034,s037ltr.pdf 10/16/2014
AP010/15/2014SE840815033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s033s034s037lbl.pdf 10/16/2014
AP010/15/2014SE840816034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s033s034s037lbl.pdf 10/16/2014
AP010/15/2014SE840797034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021928Orig1s033,s034,s037ltr.pdf 10/16/2014
AP07/28/2014SCM       
AP09/19/2014SE840584036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021928Orig1s032,s036,s038ltr.pdf 9/24/2014
AP09/19/2014SE840548036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s032s036s038lbl.pdf 9/22/2014
AP010/15/2014SLR40795037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021928Orig1s033,s034,s037ltr.pdf 10/16/2014
AP010/15/2014SLR40817037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s033s034s037lbl.pdf 10/16/2014
AP09/19/2014SLR40549038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021928s032s036s038lbl.pdf 9/22/2014
AP09/19/2014SLR40585038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021928Orig1s032,s036,s038ltr.pdf 9/24/2014
AP08/12/2016SE846782039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021928Orig1s039,s041ltr.pdf 8/15/2016
AP08/12/2016SE846790039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021928s039s041lbl.pdf 8/17/2016
AP08/12/2016SLR46791041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021928s039s041lbl.pdf 8/17/2016
AP08/12/2016SLR46781041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021928Orig1s039,s041ltr.pdf 8/15/2016




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