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FDA Drug Application 021266 by PF PRISM CV

Application Number021266
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
AP05/24/2002N25347000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-266_21-267_Vfend.cfm 4/28/2010
AP05/24/2002N25348000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21266ltr.pdf 4/28/2010
AP05/24/2002N25349000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21266lbl.pdf 4/28/2010
AP03/28/2003SLR4661002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21267slr003,21266slr002_vfend_lbl.pdf 3/28/2003
AP03/28/2003SLR5247002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21267slr003,21266slr002ltr.pdf 4/14/2003
AP04/21/2004SLR8412005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266slr005,006,21267slr005,006,21630slr001ltr.pdf 4/29/2004
AP04/21/2004SLR8497005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf 5/4/2004
AP04/21/2004SLR15640005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021266s005s006,021267s005s006,021630s001_VfendTOC.cfm 1/10/2007
AP04/21/2004SLR8413006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266slr005,006,21267slr005,006,21630slr001ltr.pdf 4/29/2004
AP04/21/2004SLR8498006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf 5/4/2004
AP04/21/2004SLR15641006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021266s005s006,021267s005s006,021630s001_VfendTOC.cfm 1/10/2007
AP02/4/2004SLR7751007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266slr007,21267slr007ltr.pdf 2/27/2004
AP02/4/2004SLR7828007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr007,21267slr007_vfend_lbl.pdf 3/3/2004
AP012/21/2004SE110821009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266s009,21267s009,21630s003ltr.pdf 12/29/2004
AP012/21/2004SE110838009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266s009,21267s009,21630s003lbl.pdf 12/29/2004
AP012/21/2004SE134353009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021266Orig1s009.pdf 11/9/2012
AP03/24/2005SLR11295010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21266s010,21267s010,21630s004ltr.pdf 3/29/2005
AP03/24/2005SLR11305010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21266s010,21267s010,21630s004lbl.pdf 3/29/2005
AP07/7/2005SLR11968012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s012_021267s011_021630s005lbl.pdf 7/8/2005
AP07/7/2005SLR12007012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021630s005,021266s012,021267s011ltr.pdf 7/15/2005
AP012/18/2005SLR13340013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s013,021267s012,021630s006lbl.pdf 1/5/2006
AP012/18/2005SLR13417013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021266s013,021267s012,021630s006ltr.pdf 1/19/2006
AP03/10/2006SLR13780015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021630s008,021267s015,021266s015ltr.pdf 3/22/2006
AP03/10/2006SLR13781015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021630s008,021267s015,021266s015lbl.pdf 3/22/2006
AP02/5/2008SLR19076016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s016ltr.pdf 2/7/2008
AP02/5/2008SLR19126016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s016,021267s016,021630s009lbl.pdf 2/14/2008
AP05/19/2006SLR14147018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s18,021267s19,021630s10lbl.pdf 5/22/2006
AP05/19/2006SLR14157018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021266s018,021267s019,021630s010LTR .pdf 5/22/2006
AP012/1/2006SLR15410019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s019,021267s021,021630s011lbl.pdf 12/4/2006
AP012/1/2006SLR15572019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021266s019, 021267s021, 021630s011ltr.pdf 12/28/2006
AP012/15/2010SLR       
AP03/10/2008SLR19431023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s023, 021267s024, 021630s013ltr.pdf 3/13/2008
AP03/10/2008SLR19438023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s023,021267s024,021630s013lbl.pdf 3/13/2008
AP06/17/2010SLR25798025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf 6/24/2010
AP06/17/2010SLR25807025   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
AP05/30/2008SLR19915026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s026, 021267s026, 021630s015ltr.pdf 6/3/2008
AP06/17/2010SLR25799027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf 6/24/2010
AP06/17/2010SLR25808027   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
AP06/17/2010SLR25800029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf 6/24/2010
AP06/17/2010SLR25809029   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
AP06/17/2010SLR25801030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf 6/24/2010
AP06/17/2010SLR25810030   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
AP012/15/2010SLR27307031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s031,021267s034,021630s022ltr.pdf 12/21/2010
AP012/15/2010SLR27386031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s031,021267s034,021630s022lbl.pdf 12/26/2010
AP011/21/2010SLR27094032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s032,021267s036,021630s023ltr.pdf 11/30/2010
AP011/21/2010SLR27222032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s032lbl.pdf 11/21/2010
AP06/1/2011SLR29013033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s033,021267s037,021630s024ltr.pdf 6/2/2011
AP06/1/2011SLR29187033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s033,021267s037,021630s024lbl.pdf 6/16/2011
AP012/15/2010SLR       
AP011/16/2011SLR30661035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021266s035,021267s040,021630s026ltr.pdf 11/21/2011
AP011/16/2011SLR30698035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s035,021267s040,021630s026lbl.pdf 11/21/2011
AP03/1/2013SCM       
AP04/7/2014SLR38993037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021266Orig1s037,021267Orig1s044,021630Orig1s027ltr.pdf 4/8/2014
AP04/7/2014SLR39008037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021266s037,021267s044,021630s027lbl.pdf 4/8/2014
AP02/3/2015SLR41782038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021266Orig1s038,021267Orig1s047,021630Orig1s028ltr.pdf 2/5/2015
AP02/3/2015SLR41788038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021266s038,021267s047,021630s028lbl.pdf 2/5/2015
AP010/17/2016SCM       




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