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FDA Drug Application 202570 by PF PRISM CV

Application Number202570
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 CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/26/2011N29906000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202570s000lbl.pdf 8/26/2011
AP08/26/2011N29921000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202570s000ltr.pdf 8/30/2011
AP08/26/2011N30095000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202570Orig1s000TOC.cfm 9/27/2011
AP08/26/2011N30096000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202570Orig1s000SumR.pdf 9/27/2011
AP02/17/2012SLR31969002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202570s002ltr.pdf 2/29/2012
AP02/17/2012SLR32115002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202570s002lbl.pdf 3/15/2012
AP02/24/2012SLR31922003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202570s003lbl.pdf 2/28/2012
AP02/24/2012SLR31965003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202570s003ltr.pdf 2/29/2012
AP02/28/2013SLR35311004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202570Orig1s004ltr.pdf 3/1/2013
AP02/28/2013SLR35470004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s004lbl.pdf 3/15/2013
AP03/12/2013SCM       
AP011/20/2013SE837889006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s006lbl.pdf 11/22/2013
AP011/20/2013SE837903006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202570Orig1s006ltr.pdf 11/25/2013
AP010/7/2013SLR37375007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202570s007,s009ltr.pdf 10/8/2013
AP010/7/2013SLR37376007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s007lbl.pdf 10/8/2013
AP09/13/2013SCM       
AP010/7/2013SLR37374009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202570s009lbl.pdf 10/7/2013
AP010/7/2013SLR37377009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202570Orig1s007,s009ltr.pdf 10/8/2013
AP02/14/2014SCM       
AP05/28/2014SLR39402011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202570s011lbl.pdf 5/30/2014
AP05/28/2014SLR39409011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202570Orig1s011ltr.pdf 6/2/2014
AP08/26/2014SCM       
AP03/20/2015SLR42240013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202570Orig1s013ltr.pdf 3/24/2015
AP03/20/2015SLR42254013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202570s013lbl.pdf 3/24/2015
AP09/14/2015SE843884014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202570Orig1s014ltr.pdf 9/16/2015
AP09/14/2015SE843974014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202570s014lbl.pdf 9/23/2015
AP012/7/2015SCM       
AP03/11/2016SE845421016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202570s016lbl.pdf 3/11/2016
AP03/11/2016SE847490016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202570Orig1s016ltr.pdf 10/28/2016
AP04/29/2016SLR45842017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202570s017lbl.pdf 5/3/2016
AP04/29/2016SLR45860017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202570Orig1s017ltr.pdf 5/4/2016
AP04/28/2016SLR45808018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202570s018lbl.pdf 4/29/2016
AP04/28/2016SLR45825018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202570Orig1s018ltr.pdf 5/2/2016




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