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FDA Drug Application 021267 by PF PRISM CV

Application Number021267
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
AP05/24/2002N7011000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-266_21-267_Vfend.cfm 12/2/2003
AP05/24/2002N9618000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-266_VFEND_prntlbl.pdf 6/30/2004
AP05/24/2002N9619000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-266_VFEND_Approv.pdf 6/30/2004
AP03/28/2003SLR4660003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21267slr003,21266slr002_vfend_lbl.pdf 3/28/2003
AP03/28/2003SLR5246003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21267slr003,21266slr002ltr.pdf 4/14/2003
AP04/21/2004SLR8414005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266slr005,006,21267slr005,006,21630slr001ltr.pdf 4/29/2004
AP04/21/2004SLR8499005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf 5/4/2004
AP04/21/2004SLR15638005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021266s005s006,021267s005s006,021630s001_VfendTOC.cfm 1/10/2007
AP04/21/2004SLR8415006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266slr005,006,21267slr005,006,21630slr001ltr.pdf 4/29/2004
AP04/21/2004SLR8500006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf 5/4/2004
AP04/21/2004SLR15639006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021266s005s006,021267s005s006,021630s001_VfendTOC.cfm 1/10/2007
AP02/4/2004SLR7752007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266slr007,21267slr007ltr.pdf 2/27/2004
AP02/4/2004SLR7829007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr007,21267slr007_vfend_lbl.pdf 3/3/2004
AP012/21/2004SE110822009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266s009,21267s009,21630s003ltr.pdf 12/29/2004
AP012/21/2004SE110839009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266s009,21267s009,21630s003lbl.pdf 12/29/2004
AP012/21/2004SE134354009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021267Orig1s009.pdf 11/9/2012
AP03/24/2005SLR11296010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21266s010,21267s010,21630s004ltr.pdf 3/29/2005
AP03/24/2005SLR11306010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21266s010,21267s010,21630s004lbl.pdf 3/29/2005
AP07/7/2005SLR11969011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s012_021267s011_021630s005lbl.pdf 7/8/2005
AP07/7/2005SLR12006011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021630s005,021266s012,021267s011ltr.pdf 7/15/2005
AP012/18/2005SLR13341012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s013,021267s012,021630s006lbl.pdf 1/5/2006
AP012/18/2005SLR13416012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021266s013,021267s012,021630s006ltr.pdf 1/19/2006
AP03/10/2006SLR13778015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021630s008,021267s015,021266s015ltr.pdf 3/22/2006
AP03/10/2006SLR13779015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021630s008,021267s015,021266s015lbl.pdf 3/22/2006
AP02/5/2008SLR19075016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021267s016ltr.pdf 2/7/2008
AP02/5/2008SLR19127016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s016,021267s016,021630s009lbl.pdf 2/14/2008
AP05/19/2006SLR14148019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s18,021267s19,021630s10lbl.pdf 5/22/2006
AP05/19/2006SLR14156019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021266s018,021267s019,021630s010LTR .pdf 5/22/2006
AP012/1/2006SLR15409021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s019,021267s021,021630s011lbl.pdf 12/4/2006
AP012/1/2006SLR15571021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021266s019, 021267s021, 021630s011ltr.pdf 12/28/2006
AP03/10/2008SLR19432024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s023, 021267s024, 021630s013ltr.pdf 3/13/2008
AP03/10/2008SLR19437024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s023,021267s024,021630s013lbl.pdf 3/13/2008
AP06/17/2010SLR25794025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf 6/24/2010
AP06/17/2010SLR25811025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf 6/24/2010
AP05/30/2008SLR19916026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s026, 021267s026, 021630s015ltr.pdf 6/3/2008
AP06/17/2010SLR25795029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf 6/24/2010
AP06/17/2010SLR25812029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf 6/24/2010
AP06/17/2010SLR25796032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf 6/24/2010
AP06/17/2010SLR25813032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf 6/24/2010
AP06/17/2010SLR25797033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf 6/24/2010
AP06/17/2010SLR25814033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s025,s027,s029,s030;021267s025,s029,s032,s033;021630s014,s018,s020,s021ltr.pdf 6/24/2010
AP012/15/2010SLR27308034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s031,021267s034,021630s022ltr.pdf 12/21/2010
AP012/15/2010SLR27387034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s031,021267s034,021630s022lbl.pdf 12/26/2010
AP011/21/2010SLR27095036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s032,021267s036,021630s023ltr.pdf 11/30/2010
AP011/21/2010SLR27223036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021267s036lbl.pdf 11/21/2010
AP06/1/2011SLR29014037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s033,021267s037,021630s024ltr.pdf 6/2/2011
AP06/1/2011SLR29186037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s033,021267s037,021630s024lbl.pdf 6/16/2011
AP011/16/2011SLR30662040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021266s035,021267s040,021630s026ltr.pdf 11/21/2011
AP011/16/2011SLR30699040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s035,021267s040,021630s026lbl.pdf 11/21/2011
AP07/25/2013SCM       
AP04/7/2014SLR38994044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021266Orig1s037,021267Orig1s044,021630Orig1s027ltr.pdf 4/8/2014
AP04/7/2014SLR39007044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021266s037,021267s044,021630s027lbl.pdf 4/8/2014
AP06/9/2014SCM       
AP06/24/2014SCM       
AP02/3/2015SLR41783047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021266Orig1s038,021267Orig1s047,021630Orig1s028ltr.pdf 2/5/2015
AP02/3/2015SLR41789047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021266s038,021267s047,021630s028lbl.pdf 2/5/2015
AP01/15/2016SCM       




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