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FDA Drug Application 203214 by PF PRISM CV

Application Number203214
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
AP011/6/2012N34334000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203214Orig1s000ltr.pdf 11/7/2012
AP011/6/2012N34481000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203214s000lbl.pdf 11/28/2012
AP011/6/2012N34536000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM330702.pdf 12/4/2012
AP011/6/2012N34694000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203214Orig1s000TOC.cfm 12/18/2012
AP011/6/2012N34695000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203214Orig1s000SumR.pdf 12/18/2012
AP05/3/2013SCM       
AP011/18/2013SE843997002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203214Orig1s002.pdf 9/25/2015
AP011/18/2013SE837863002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203214Orig1s002ltr.pdf 11/20/2013
AP011/18/2013SE837893002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203214s002lbl.pdf 11/22/2013
AP02/21/2014SE838569004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203214Orig1s004ltr.pdf 2/25/2014
AP02/21/2014SE838591004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203214s004lbl.pdf 2/25/2014
AP03/26/2014SLR38928005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203214Orig1s005ltr.pdf 3/28/2014
AP03/26/2014SLR38939005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203214s005lbl.pdf 4/1/2014
AP011/8/2013S37791006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203214Orig1s006ltr.pdf 11/12/2013
AP05/7/2014SLR39257007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203214Orig1s007ltr.pdf 5/8/2014
AP05/7/2014SLR39272007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203214s007lbl.pdf 5/12/2014
AP02/11/2015SLR41849008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203214Orig1s008ltr.pdf 2/17/2015
AP06/19/2015SLR43106010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203214s010lbl.pdf 6/23/2015
AP06/19/2015SLR43110010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203214Orig1s010ltr.pdf 6/24/2015
AP012/22/2015SLR44867011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203214Orig1s011ltr.pdf 12/23/2015
AP02/8/2016S45136013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203214Orig1s013ltr.pdf 2/9/2016




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