Back to FDA Applications sponsored by PF PRISM CV

FDA Drug Application 021083 by PF PRISM CV

Application Number021083
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
AP09/15/1999N1141000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21083A.cfm 9/15/1999
AP09/15/1999N5029000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21083A_Rapamune_appltr.pdf 9/15/1999
AP09/15/1999N27227000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM235958.pdf 12/7/2010
AP03/17/2000SCE       
AP05/3/2000SLR       
AP08/25/2000SLR       
AP01/23/2003SLR4141005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf 1/23/2003
AP01/23/2003SLR4142005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf 1/23/2003
AP04/11/2003SE15211006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021083s006lbl.pdf 4/11/2003
AP04/11/2003SE15383006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083se1-006,21110se1-004ltr.pdf 4/18/2003
AP04/11/2003SE123290006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021083_S006_RAPAMUNE.pdf 9/14/2009
AP01/23/2003SLR4143007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf 1/23/2003
AP01/23/2003SLR4144007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf 1/23/2003
AP01/23/2003SLR4145008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf 1/23/2003
AP01/23/2003SLR4146008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf 1/23/2003
AP01/23/2003SLR4147009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf 1/23/2003
AP01/23/2003SLR4148009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf 1/23/2003
AP01/23/2003SLR4149010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf 1/23/2003
AP01/23/2003SLR4150010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf 1/23/2003
AP03/26/2003SLR4479014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21110slr013,21083slr014_Rapamune_lbl.pdf 3/26/2003
AP03/26/2003SLR9355014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21110slr013,21083slr014ltr.pdf 6/14/2004
AP010/2/2003SLR6757015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr015,21110slr015ltr.pdf 10/9/2003
AP010/2/2003SLR6781015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr015,21110slr015_Rapamune_lbl.pdf 10/10/2003
AP07/20/2004SLR9833017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21083s017,21110s020ltr.pdf 7/21/2004
AP07/20/2004SLR9840017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21083s017,21110s020lbl.pdf 7/21/2004
AP03/11/2005SE511245019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21083s019,21110s024ltr.pdf 3/14/2005
AP03/11/2005SE511248019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21083s019,21110s024lbl.pdf 3/14/2005
AP06/30/2005SLR11938020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s020,021,021110s027,028lbl.pdf 7/7/2005
AP06/30/2005SLR11954020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s020,021,021110s027,028ltr.pdf 7/8/2005
AP06/30/2005SLR11939021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s020,021,021110s027,028lbl.pdf 7/7/2005
AP06/30/2005SLR11955021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s020,021,021110s027,028ltr.pdf 7/8/2005
AP010/7/2005SLR12873022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s022,023,021110s030,031ltr.pdf 10/14/2005
AP010/7/2005SLR12884022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s022,023,021110s030,031lbl.pdf 10/14/2005
AP010/7/2005SLR12874023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s022,023,021110s030,031ltr.pdf 10/14/2005
AP010/7/2005SLR12885023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s022,023,021110s030,031lbl.pdf 10/14/2005
AP06/2/2006SE814228024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s024s025,021110s032s034lbl.pdf 6/6/2006
AP06/2/2006SE814238024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021083s024, s025, 021110s032, s034LTR.pdf 6/6/2006
AP06/2/2006SLR14229025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s024s025,021110s032s034lbl.pdf 6/6/2006
AP06/2/2006SLR14239025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021083s024, s025, 021110s032, s034LTR.pdf 6/6/2006
AP01/9/2007SLR15649026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s026,021110s035lbl.pdf 1/16/2007
AP01/9/2007SLR15665026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s026, 021110s035_ltr.pdf 1/16/2007
AP010/19/2006SLR15156028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s028,021110s036lbl.pdf 10/23/2006
AP01/30/2007SE515780029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s029, 021110s037ltr.pdf 2/12/2007
AP01/12/2007SLR15650030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s030,021110s038lbl.pdf 1/16/2007
AP01/12/2007SLR15715030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s030, 021101s038ltr.pdf 1/25/2007
AP05/2/2007SLR16446031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s031,021110s039lbl.pdf 5/7/2007
AP05/2/2007SLR16490031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s031,021110s039ltr.pdf 5/9/2007
AP01/14/2008SE818893033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021083s033,021110s043lbl.pdf 1/18/2008
AP01/14/2008SE818902033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021083s033,021110s043_CKD.pdf 1/18/2008
AP010/17/2007SLR18259034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s034,021110s045lbl.pdf 10/22/2007
AP010/17/2007SLR18273034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s034,021110s045ltr.pdf 10/22/2007
AP03/5/2008SLR19388036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021083s036, s037, 021110s047, s048ltr.pdf 3/7/2008
AP03/5/2008SLR19402036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021083s036s037,021110s047s048lbl.pdf 3/7/2008
AP03/5/2008SLR19403037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021083s036s037,021110s047s048lbl.pdf 3/7/2008
AP03/5/2008SLR19407037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021083s036, s037, 021110s047, s048ltr.pdf 3/10/2008
AP01/29/2009SLR21772038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s038,021110s049lbl.pdf 2/4/2009
AP09/24/2009SLR23504040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s040,021110s050lbl.pdf 10/1/2009
AP09/24/2009SLR23795040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021083s040,021110s050ltr.pdf 11/10/2009
AP010/8/2009SLR23582041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s041,021110s051lbl.pdf 10/14/2009
AP010/8/2009SLR23794041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021110s051,021083s041ltr.pdf 11/10/2009
AP04/22/2010SLR25356042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s042,s043,21110s053,s054ltr.pdf 4/28/2010
AP04/22/2010SLR25427042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s042s043,021110s053s054lbl.pdf 5/3/2010
AP04/22/2010SLR25357043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s042,s043,21110s053,s054ltr.pdf 4/28/2010
AP04/22/2010SLR25428043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s042s043,021110s053s054lbl.pdf 5/3/2010
AP011/23/2010SLR27126044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s044s047,021083s044s047lbl.pdf 12/1/2010
AP011/23/2010SLR27251044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021110s055s057,021083s044,s047ltr.pdf 12/7/2010
AP01/25/2010SLR24691045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s045,021110s052ltr.pdf 2/1/2010
AP01/25/2010SLR24718045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s045,021110s052lbl.pdf 2/4/2010
AP07/2/2010SLR25937046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s046,021110s056ltr.pdf 7/8/2010
AP07/2/2010SLR26293046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s046,021110s056lbl.pdf 8/27/2010
AP011/23/2010SLR27127047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s044s047,021083s044s047lbl.pdf 12/1/2010
AP011/23/2010SLR27252047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021110s055s057,021083s044,s047ltr.pdf 12/7/2010
AP011/8/2010SLR26902048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s048,021110s058ltr.pdf 11/8/2010
AP011/8/2010SLR26911048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s048lbl.pdf 11/4/2010
AP07/11/2011SLR29504049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021083s049,021110s059ltr.pdf 7/13/2011
AP06/6/2011SLR29083050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021083s050,021110s060ltr.pdf 6/9/2011
AP012/10/2012SLR34599051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021083Orig1s051,021110Orig1s065ltr.pdf 12/11/2012
AP012/10/2012SLR34665051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021083s051,021110s065lbl.pdf 12/14/2012
AP03/7/2013SLR35371053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021083Orig1s053,021110Orig1s067ltr.pdf 3/8/2013
AP03/7/2013SLR35376053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021083s053,021110s067lbl.pdf 3/8/2013
AP05/30/2013SLR37132054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021110Orig1s068,021083Orig1s054ltr.pdf 9/17/2013
AP05/28/2015SE842947055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021083Orig1s055,021110Orig1s073ltr.pdf 5/29/2015
AP05/28/2015SE842953055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s055,021110s073lbl.pdf 6/1/2015
AP03/6/2015SLR42059056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s056,021110s074lbl.pdf 3/9/2015
AP03/6/2015SLR42073056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021083Orig1s056,021110Orig1s074ltr.pdf 3/10/2015
AP07/31/2015SCM       
AP011/5/2015SLR44426058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021083Orig1s058,021110Orig1075ltr.pdf 11/9/2015
AP011/5/2015SLR44440058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s058,021110s075lbl.pdf 11/12/2015




Back to FDA Applications sponsored by PF PRISM CV