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FDA Drug Application 021540 by PFIZER

Application Number021540
Application Type New Drug Application
Sponsor ApplicantPFIZER
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/30/2004N7668000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21540ltr.pdf 2/3/2004
AP01/30/2004N7669000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21540_caduet_lbl.pdf 2/3/2004
AP01/30/2004N9935000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021540S000_Caduet.cfm 8/5/2004
AP09/27/2004S10307003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21540s003ltr.pdf 9/29/2004
AP09/27/2004S10308003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21540s003lbl.pdf 9/29/2004
AP08/28/2006SLR14766006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021540s006lbl.pdf 8/29/2006
AP08/28/2006SLR14867006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021540s006ltr.pdf 9/18/2006
AP04/13/2006SLR13940008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021540s008lbl.pdf 4/14/2006
AP04/13/2006SLR13948008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021540s008ltr.pdf 4/20/2006
AP09/20/2007SLR17973009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021540s009ltr.pdf 9/25/2007
AP09/20/2007SLR18010009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021540s009lbl.pdf 9/26/2007
AP09/20/2007SLR17974011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021540s011ltr.pdf 9/25/2007
AP09/20/2007SLR18011011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021540s011lbl.pdf 9/26/2007
AP05/29/2008SLR19913014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021540s014ltr.pdf 6/2/2008
AP07/20/2009SLR23059018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021540s018lbl.pdf 7/23/2009
AP07/20/2009SLR24130018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021540s018ltr.pdf 11/24/2009
AP02/17/2010SLR24831019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021540s019ltr.pdf 2/23/2010
AP02/17/2010SLR24834019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021540s019lbl.pdf 2/23/2010
AP07/26/2012SLR33290023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021540Orig1s023,s026ltr.pdf 7/30/2012
AP07/26/2012SLR33308023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021540s023s026lbl.pdf 7/30/2012
AP07/26/2012SLR33291026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021540Orig1s023,s026ltr.pdf 7/30/2012
AP07/26/2012SLR33309026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021540s023s026lbl.pdf 7/30/2012
AP010/31/2012SLR34228028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021540s028lbl.pdf 11/2/2012
AP010/31/2012SLR34267028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021540Orig1s028ltr.pdf 11/6/2012
AP07/31/2013SCM       
AP011/7/2013SLR37786030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021540Orig1s030,s031ltr.pdf 11/12/2013
AP011/7/2013SLR37806030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021540s030s031lbl.pdf 11/13/2013
AP011/7/2013SLR37785031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021540Orig1s030,s031ltr.pdf 11/12/2013
AP011/7/2013SLR37807031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021540s030s031lbl.pdf 11/13/2013
AP04/21/2014SCM       
AP05/22/2014SLR39353034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021540Orig1s034ltr.pdf 5/27/2014
AP05/22/2014SLR39384034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021540s034lbl.pdf 5/28/2014
AP07/28/2014SCM       
AP03/23/2015SLR42264036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021540Orig1s036ltr.pdf 3/25/2015
AP03/23/2015SLR42311036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021540s036lbl.pdf 3/27/2015
AP02/17/2015SLR41871037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021540Orig1s037ltr.pdf 2/19/2015
AP02/17/2015SLR42313037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021540s037lbl.pdf 3/27/2015




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