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FDA Drug Application 021483 by PFIZER INC

Application Number021483
Application Type New Drug Application
Sponsor ApplicantPFIZER INC
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
AP03/29/2006N13843000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021483s000ltr.pdf 4/5/2006
AP03/29/2006N13867000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm 4/5/2006
AP03/29/2006N16858000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021483s000TOC.cfm 6/29/2007
AP08/7/2009SLR23409003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021483s003lbl.pdf 9/18/2009
AP08/7/2009SLR24131003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021483s003ltr.pdf 11/24/2009
AP012/1/2010SLR27166005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020825s038,020919s025,021483s005lbl.pdf 12/4/2010
AP012/1/2010SLR27235005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020825s038,020919s025,021483s005ltr.pdf 12/7/2010
AP07/3/2013SLR36455007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s041,020919Orig1s027,021483Orig1s007ltr.pdf 7/5/2013
AP07/3/2013SLR36467007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s041,020919s027,021483s007lbl.pdf 7/5/2013
AP03/1/2013SLR35332009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s046,020919s030,021483s009lbl.pdf 3/4/2013
AP03/1/2013SLR35346009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Origs046,020919Orig1s030,021483Orig1s009ltr.pdf 3/5/2013
AP08/13/2013SLR36802010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020825s047,020919s032,021483s010lbl.pdf 8/15/2013
AP08/13/2013SLR36810010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020825Orig1s047,020919Orig1s032,021483Orig1s010ltr.pdf 8/16/2013
AP05/21/2014SCM       
AP012/10/2014SLR41216013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020825Orig1s053,020919Orig1s040,021483Orig1s013ltr.pdf 12/11/2014
AP012/10/2014SLR41218013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020825s053,020919s040,s021483s013lbl.pdf 12/11/2014
AP08/20/2015SLR43700014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020825Orig1s054,020919Orig1s041,021483Orig1s014ltr.pdf 8/24/2015
AP08/20/2015SLR43860014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020825s054,020919s041,021483s014lbl.pdf 9/14/2015




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