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FDA Drug Application 050797 by PF PRISM CV

Application Number050797
Application Type New Drug Application
Sponsor ApplicantPF PRISM CV
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/10/2005N11795000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050797lbl.pdf 6/14/2005
AP06/10/2005N11796000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050797ltr.pdf 6/14/2005
AP06/10/2005N17817000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/050797s000TOC.cfm 9/10/2007
AP06/10/2005N35403000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm343281.htm 3/12/2013
AP010/25/2007SLR18326001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050797s001lbl.pdf 11/7/2007
AP010/25/2007SLR18398001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050797s001ltr.pdf 11/8/2007
AP010/7/2008SE520987008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050797s008ltr.pdf 10/9/2008
AP010/7/2008SE521012008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050797s008lbl.pdf 10/9/2008
AP06/7/2011SLR29091010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050797s010,s012,s014ltr.pdf 6/10/2011
AP06/7/2011SLR30042010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050797s010s012s014lbl.pdf 9/20/2011
AP06/7/2011SLR30043012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050797s010s012s014lbl.pdf 9/20/2011
AP06/7/2011SLR29092012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050797s010,s012,s014ltr.pdf 6/10/2011
AP010/11/2013SLR37418013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050797Orig1s013ltr.pdf 10/15/2013
AP010/11/2013SLR37437013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050797s013lbl.pdf 10/17/2013
AP06/7/2011SLR29093014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050797s010,s012,s014ltr.pdf 6/10/2011
AP06/7/2011SLR30044014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050797s010s012s014lbl.pdf 9/20/2011
AP03/1/2012SLR32016016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050797s016ltr.pdf 3/5/2012
AP03/1/2012SLR32048016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050797s016lbl.pdf 3/6/2012
AP02/19/2013SLR35202017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050797Orig1s017ltr.pdf 2/21/2013
AP02/19/2013SLR35218017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050797s017lbl.pdf 2/21/2013
AP07/2/2015SLR43253019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050797s019lbl.pdf 7/6/2015
AP07/2/2015SLR43310019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050797Orig1s019ltr.pdf 7/10/2015
AP05/24/2016SLR46148020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050797s020lbl.pdf 5/25/2016
AP05/24/2016SLR46158020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050797Orig1s020ltr.pdf 5/26/2016
AP06/27/2016SCM       




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