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FDA Drug Application 022088 by PF PRISM CV

Application Number022088
Application Type New Drug Application
Sponsor ApplicantPF PRISM CV
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
AP05/30/2007N16664000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022088s000ltr.pdf 6/4/2007
AP05/30/2007N16695000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022088lbl.pdf 6/4/2007
AP05/30/2007N17418000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022088s000TOC.cfm 7/30/2007
AP011/9/2007SCP18419001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022088s001lbl.pdf 11/19/2007
AP011/9/2007SCP18464001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022088s001ltr.pdf 11/19/2007
AP06/16/2011SLR29191002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf 6/16/2011
AP06/16/2011SLR29258002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022088s002,s004,s005,s007,s010,s012ltr.pdf 6/27/2011
AP06/16/2011SLR29192004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf 6/16/2011
AP06/16/2011SLR29259004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022088s002,s004,s005,s007,s010,s012ltr.pdf 6/27/2011
AP06/16/2011SLR29193005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf 6/16/2011
AP06/16/2011SLR29260005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022088s002,s004,s005,s007,s010,s012ltr.pdf 6/27/2011
AP04/26/2010SE825360006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022088s006lbl.pdf 4/28/2010
AP04/26/2010SE825388006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022088s006ltr.pdf 4/29/2010
AP06/16/2011SLR29194007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf 6/16/2011
AP06/16/2011SLR29261007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022088s002,s004,s005,s007,s010,s012ltr.pdf 6/27/2011
AP07/9/2010SE225956008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022088s008lbl.pdf 7/12/2010
AP07/9/2010SE225967008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022088s008ltr.pdf 7/14/2010
AP06/16/2011SLR29195010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf 6/16/2011
AP06/16/2011SLR29262010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022088s002,s004,s005,s007,s010,s012ltr.pdf 6/27/2011
AP06/16/2011SLR29196012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf 6/16/2011
AP06/16/2011SLR29263012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022088s002,s004,s005,s007,s010,s012ltr.pdf 6/27/2011
AP05/30/2012SE532785014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022088s014ltr.pdf 6/4/2012
AP05/30/2012SE532832014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022088s014lbl.pdf 6/6/2012
AP012/20/2013SCM       
AP04/7/2014SLR38998016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022088Orig1s016ltr.pdf 4/8/2014
AP04/7/2014SLR39014016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022088s016lbl.pdf 4/8/2014
AP010/7/2014SLR40733017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022088Orig1s017ltr.pdf 10/9/2014
AP010/7/2014SLR40742017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022088s017lbl.pdf 10/9/2014
AP02/26/2015SLR41949018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022088Orig1s018ltr.pdf 2/27/2015
AP02/26/2015SLR41969018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022088s018lbl.pdf 3/2/2015
AP07/27/2016SLR46663019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022088Orig1s019ltr.pdf 7/28/2016
AP07/27/2016SLR46668019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022088s019lbl.pdf 7/28/2016




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