Back to FDA Applications sponsored by PF PRISM CV

FDA Drug Application 202324 by PF PRISM CV

Application Number202324
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/27/2012N31531000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202324lbl.pdf 1/27/2012
AP01/27/2012N31595000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202324s000ltr.pdf 1/31/2012
AP01/27/2012N31913000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202324Orig1s000TOC.cfm 2/27/2012
AP01/27/2012N31914000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202324Orig1s000SumR.pdf 2/27/2012
AP09/16/2013N37098001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202324s001lbl.pdf 9/16/2013
AP09/16/2013N37136001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202324Orig1s001ltr.pdf 9/17/2013
AP08/1/2014SLR40115002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202324Orig1s002ltr.pdf 8/4/2014
AP08/1/2014SLR40119002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202324s002lbl.pdf 8/4/2014
AP012/29/2014SLR41461003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202324Orig1s003ltr.pdf 12/31/2014
AP012/29/2014SLR44898003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202324Orig1s003lbl.pdf 12/29/2015
AP03/30/2016SCM       
AP06/16/2016SCM       




Back to FDA Applications sponsored by PF PRISM CV

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.