Back to FDA Applications sponsored by PF PRISM CV

FDA Drug Application 021630 by PF PRISM CV

Application Number021630
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
AP012/19/2003N7422000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21630ltr.pdf 12/24/2003
AP012/19/2003N7440000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21630_vfend_lb.pdf 12/29/2003
AP012/19/2003N14533000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021630s000_VfendTOC.cfm 7/25/2006
AP04/21/2004SLR8416001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266slr005,006,21267slr005,006,21630slr001ltr.pdf 4/29/2004
AP04/21/2004SLR8501001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266slr005,006,21267slr005,006,21630slr001_vfend_lbl.pdf 5/4/2004
AP04/21/2004SLR15637001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021266s005s006,021267s005s006,021630s001_VfendTOC.cfm 1/10/2007
AP012/21/2004SE110823003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21266s009,21267s009,21630s003ltr.pdf 12/29/2004
AP012/21/2004SE110840003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21266s009,21267s009,21630s003lbl.pdf 12/29/2004
AP012/21/2004SE134355003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021630Orig1s003.pdf 11/9/2012
AP03/24/2005SLR11297004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21266s010,21267s010,21630s004ltr.pdf 3/29/2005
AP03/24/2005SLR11307004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21266s010,21267s010,21630s004lbl.pdf 3/29/2005
AP07/7/2005SLR11970005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s012_021267s011_021630s005lbl.pdf 7/8/2005
AP07/7/2005SLR12008005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021630s005,021266s012,021267s011ltr.pdf 7/15/2005
AP012/18/2005SLR13342006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021266s013,021267s012,021630s006lbl.pdf 1/5/2006
AP012/18/2005SLR13415006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021266s013,021267s012,021630s006ltr.pdf 1/19/2006
AP03/10/2006SLR13782008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021630s008,021267s015,021266s015ltr.pdf 3/22/2006
AP03/10/2006SLR13783008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021630s008,021267s015,021266s015lbl.pdf 3/22/2006
AP02/5/2008SLR19077009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021630s009ltr.pdf 2/7/2008
AP02/5/2008SLR19128009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s016,021267s016,021630s009lbl.pdf 2/14/2008
AP05/19/2006SLR14146010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s18,021267s19,021630s10lbl.pdf 5/22/2006
AP05/19/2006SLR14155010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021266s018,021267s019,021630s010LTR .pdf 5/22/2006
AP012/1/2006SLR15408011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021266s019,021267s021,021630s011lbl.pdf 12/4/2006
AP012/1/2006SLR15570011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021266s019, 021267s021, 021630s011ltr.pdf 12/28/2006
AP03/10/2008SLR19433013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s023, 021267s024, 021630s013ltr.pdf 3/13/2008
AP03/10/2008SLR19436013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021266s023,021267s024,021630s013lbl.pdf 3/13/2008
AP06/17/2010SLR25790014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf 6/24/2010
AP06/17/2010SLR25815014   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
AP05/30/2008SLR19917015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021266s026, 021267s026, 021630s015ltr.pdf 6/3/2008
AP06/17/2010SLR25791018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf 6/24/2010
AP06/17/2010SLR25816018   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
AP06/17/2010SLR25792020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf 6/24/2010
AP06/17/2010SLR25817020   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
AP06/17/2010SLR25793021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s025s027s029s030,021267s025s029s032s033,021630s014s018s020s021lbl.pdf 6/24/2010
AP06/17/2010SLR25818021   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
AP012/15/2010SLR27309022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s031,021267s034,021630s022ltr.pdf 12/21/2010
AP012/15/2010SLR27388022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021266s031,021267s034,021630s022lbl.pdf 12/26/2010
AP011/21/2010SLR27096023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s032,021267s036,021630s023ltr.pdf 11/30/2010
AP011/21/2010SLR27221023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021630s023lbl.pdf 11/21/2010
AP06/1/2011SLR29015024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021266s033,021267s037,021630s024ltr.pdf 6/2/2011
AP06/1/2011SLR29185024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s033,021267s037,021630s024lbl.pdf 6/16/2011
AP011/16/2011SLR30663026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021266s035,021267s040,021630s026ltr.pdf 11/21/2011
AP011/16/2011SLR30700026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021266s035,021267s040,021630s026lbl.pdf 11/21/2011
AP04/7/2014SLR38995027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021266Orig1s037,021267Orig1s044,021630Orig1s027ltr.pdf 4/8/2014
AP04/7/2014SLR39006027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021266s037,021267s044,021630s027lbl.pdf 4/8/2014
AP02/3/2015SLR41784028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021266Orig1s038,021267Orig1s047,021630Orig1s028ltr.pdf 2/5/2015
AP02/3/2015SLR41790028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021266s038,021267s047,021630s028lbl.pdf 2/5/2015




Back to FDA Applications sponsored by PF PRISM CV