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FDA Drug Application 021821 by PF PRISM CV

Application Number021821
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
AP06/15/2005N11830000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021821lbl.pdf 6/17/2005
AP06/15/2005N11837000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021821ltr.pdf 6/21/2005
AP06/15/2005N12659000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/21-821_Tygacil.cfm 8/24/2005
AP06/15/2005N31165000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm224383.htm 12/21/2011
AP07/12/2006SLR14509003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021821s003, 021821s004_ltr.pdf 7/21/2006
AP07/12/2006SCF14510004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021821s003, 021821s004_ltr.pdf 7/21/2006
AP01/24/2007SLR15750006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021821s006ltr.pdf 2/2/2007
AP04/2/2007SLR16162007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021821s007lbl.pdf 4/6/2007
AP04/2/2007SLR16171007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021821s007ltr.pdf 4/9/2007
AP05/18/2007SLR16611010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021821s010ltr.pdf 5/29/2007
AP05/18/2007SLR16645010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021821s010lbl.pdf 5/29/2007
AP01/29/2009SLR21713011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s011,021821s014,021821s019ltr.pdf 2/3/2009
AP03/20/2009SE122108013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s013s017s018lbl.pdf 3/25/2009
AP03/20/2009SE122103013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s013,021821s017,021821s018ltr.pdf 3/25/2009
AP01/29/2009SLR21784014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s011s014s019lbl.pdf 2/4/2009
AP01/29/2009SLR21714014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s011,021821s014,021821s019ltr.pdf 2/3/2009
AP02/10/2009SLR21798016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s016lbl.pdf 2/10/2009
AP02/10/2009SLR21822016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s016ltr.pdf 2/13/2009
AP03/20/2009SE122109017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s013s017s018lbl.pdf 3/25/2009
AP03/20/2009SE122104017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s013,021821s017,021821s018ltr.pdf 3/25/2009
AP03/20/2009SE122105018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s013,021821s017,021821s018ltr.pdf 3/25/2009
AP03/20/2009SE122110018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s013s017s018lbl.pdf 3/25/2009
AP01/29/2009SLR21785019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021821s011s014s019lbl.pdf 2/4/2009
AP01/29/2009SLR21715019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s011,021821s014,021821s019ltr.pdf 2/3/2009
AP07/16/2010SLR25977021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021821s021lbl.pdf 7/19/2010
AP07/16/2010SLR26008021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021821s021,021821s025,021821s027ltr.pdf 7/23/2010
AP06/26/2009SCP22859022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021821s022ltr.pdf 6/30/2009
AP07/16/2010SLR26009025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021821s021,021821s025,021821s027ltr.pdf 7/23/2010
AP07/16/2010SLR25976025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021821s025lbl.pdf 7/16/2010
AP09/26/2013SLR37238026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021821s026s031lbl.pdf 9/27/2013
AP09/26/2013SLR37269026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021821Orig1s026,s031ltr.pdf 10/1/2013
AP09/26/2013SLR38293026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021821Orig1s026.pdf 1/16/2014
AP07/16/2010SLR26010027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021821s021,021821s025,021821s027ltr.pdf 7/23/2010
AP07/16/2010SLR25975027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021821s027lbl.pdf 7/19/2010
AP09/26/2013SLR38294031   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021821Orig1s031.pdf 1/16/2014
AP09/26/2013SLR37270031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021821Orig1s026,s031ltr.pdf 10/1/2013
AP09/26/2013SLR37239031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021821s026s031lbl.pdf 9/27/2013
AP01/9/2014SCM       
AP05/23/2013SLR36145037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021821s037lbl.pdf 5/24/2013
AP05/23/2013SLR36149037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021821Orig1s037ltr.pdf 5/28/2013
AP05/31/2016SLR46207039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021821Orig1s039ltr.pdf 6/1/2016
AP05/31/2016SLR46228039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021821s039lbl.pdf 6/1/2016
AP06/29/2016SLR46444042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021821Orig1s042ltr.pdf 6/30/2016
AP06/29/2016SLR46532042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021821s042lbl.pdf 7/14/2016
AP01/19/2016SLR44993043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021821Orig1s043ltr.pdf 1/21/2016
AP01/19/2016SLR45029043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021821s043lbl.pdf 1/26/2016
AP09/7/2016SCM       




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