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FDA Drug Application 021110 by PF PRISM CV

Application Number021110
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
AP08/25/2000N1233000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21110ltr.pdf 8/25/2000
AP08/25/2000N4164000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21110_Rapamune.cfm 10/11/2001
AP08/25/2000N5028000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21110_Rapamune_prntlbl.pdf 8/25/2000
AP08/25/2000N27228000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM235958.pdf 12/7/2010
AP01/23/2003SLR4152001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf 1/23/2003
AP01/23/2003SLR4153001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf 1/23/2003
AP09/6/2001SCS       
AP08/22/2002SCF4163003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21110scf003ltr.pdf 8/22/2002
AP04/11/2003SE123291004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021083_S006_RAPAMUNE.pdf 9/14/2009
AP04/11/2003SE15212004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021083s006lbl.pdf 4/11/2003
AP04/11/2003SE15384004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083se1-006,21110se1-004ltr.pdf 4/18/2003
AP01/23/2003SLR4154005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf 1/23/2003
AP01/23/2003SLR4155005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf 1/23/2003
AP05/7/2002SCS       
AP01/23/2003SLR4156007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf 1/23/2003
AP01/23/2003SLR4157007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf 1/23/2003
AP06/5/2002SCS       
AP01/23/2003SLR4158009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf 1/23/2003
AP01/23/2003SLR4159009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf 1/23/2003
AP01/23/2003SLR4161010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr005,21110slr001_Rapamune_lbl.pdf 1/23/2003
AP01/23/2003SLR4162010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr5,7,8,9,10,21110slr1,5,7,9,10ltr.pdf 1/23/2003
AP01/31/2003SLR4182011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021110s011lbl.pdf 1/31/2003
AP01/31/2003SLR9356011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr012,%2021110slr011ltr.pdf 6/14/2004
AP02/13/2003SLR4446013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21110slr013,21083slr014_Rapamune_lbl.pdf 3/21/2003
AP02/13/2003SLR4665013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21110slr013,21083slr014ltr.pdf 3/28/2003
AP03/19/2003SLR4669014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21110slr013,21083slr014_Rapamune_lbl.pdf 3/28/2003
AP010/2/2003SLR6758015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21083slr015,21110slr015ltr.pdf 10/2/2003
AP010/2/2003SLR6782015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21083slr015,21110slr015_Rapamune_lbl.pdf 10/10/2003
AP02/23/2004SCF7764018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21110scf018ltr.pdf 3/2/2004
AP02/23/2004SCF8207018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21110scf018_rapamune_lbl.pdf 4/5/2004
AP07/20/2004SLR9834020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21083s017,21110s020ltr.pdf 7/21/2004
AP07/20/2004SLR9841020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21083s017,21110s020lbl.pdf 7/21/2004
AP03/11/2005SE511246024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21083s019,21110s024ltr.pdf 3/14/2005
AP03/11/2005SE511247024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21083s019,21110s024lbl.pdf 3/14/2005
AP06/30/2005SLR11936027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s020,021,021110s027,028lbl.pdf 7/7/2005
AP06/30/2005SLR11952027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s020,021,021110s027,028ltr.pdf 7/8/2005
AP06/30/2005SLR11953028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s020,021,021110s027,028ltr.pdf 7/8/2005
AP06/30/2005SLR11937028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s020,021,021110s027,028lbl.pdf 7/7/2005
AP010/7/2005SLR12875030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s022,023,021110s030,031ltr.pdf 10/14/2005
AP010/7/2005SLR12882030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s022,023,021110s030,031lbl.pdf 10/14/2005
AP010/7/2005SLR12883031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021083s022,023,021110s030,031lbl.pdf 10/14/2005
AP010/7/2005SLR12876031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021083s022,023,021110s030,031ltr.pdf 10/14/2005
AP06/2/2006SE814230032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s024s025,021110s032s034lbl.pdf 6/6/2006
AP06/2/2006SE814240032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021083s024, s025, 021110s032, s034LTR.pdf 6/6/2006
AP06/2/2006SLR14241034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021083s024, s025, 021110s032, s034LTR.pdf 6/6/2006
AP06/2/2006SLR14231034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s024s025,021110s032s034lbl.pdf 6/6/2006
AP01/9/2007SLR15651035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s026,021110s035lbl.pdf 1/16/2007
AP01/9/2007SLR15666035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s026, 021110s035_ltr.pdf 1/16/2007
AP010/19/2006SLR15155036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021083s028,021110s036lbl.pdf 10/23/2006
AP01/30/2007SE515779037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s029, 021110s037ltr.pdf 2/12/2007
AP01/12/2007SLR15714038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s030, 021110s038ltr.pdf 1/25/2007
AP01/12/2007SLR15648038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s030,021110s038lbl.pdf 1/16/2007
AP05/2/2007SLR16445039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s031,021110s039lbl.pdf 5/7/2007
AP05/2/2007SLR16489039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s031,021110s039ltr.pdf 5/9/2007
AP01/14/2008SE818894043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021083s033,021110s043lbl.pdf 1/18/2008
AP01/14/2008SE818903043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021083s033,021110s043_CKD.pdf 1/18/2008
AP010/17/2007SLR18260045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021083s034,021110s045lbl.pdf 10/22/2007
AP010/17/2007SLR18274045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021083s034,021110s045ltr.pdf 10/22/2007
AP03/5/2008SLR19389047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021083s036, s037, 021110s047, s048ltr.pdf 3/7/2008
AP03/5/2008SLR19408048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021083s036, s037, 021110s047, s048ltr.pdf 3/10/2008
AP01/29/2009SLR21704049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021083s038,021110s049ltr.pdf 2/3/2009
AP01/29/2009SLR21771049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s038,021110s049lbl.pdf 2/4/2009
AP09/24/2009SLR23503050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s040,021110s050lbl.pdf 10/1/2009
AP09/24/2009SLR23796050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021083s040,021110s050ltr.pdf 11/10/2009
AP010/8/2009SLR23581051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021083s041,021110s051lbl.pdf 10/14/2009
AP010/8/2009SLR23793051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021110s051,021083s041ltr.pdf 11/10/2009
AP01/25/2010SCM24692052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s045,021110s052ltr.pdf 2/1/2010
AP01/25/2010SCM24717052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s045,021110s052lbl.pdf 2/4/2010
AP04/22/2010SLR25358053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s042,s043,21110s053,s054ltr.pdf 4/28/2010
AP04/22/2010SLR25425053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s042s043,021110s053s054lbl.pdf 5/3/2010
AP04/22/2010SLR25426054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s042s043,021110s053s054lbl.pdf 5/3/2010
AP04/22/2010SLR25359054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s042,s043,21110s053,s054ltr.pdf 4/28/2010
AP011/23/2010SLR27219055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021110s055lbl.pdf 11/23/2010
AP011/23/2010SLR27249055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021110s055s057,021083s044,s047ltr.pdf 12/7/2010
AP07/2/2010SLR25938056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s046,021110s056ltr.pdf 7/8/2010
AP07/2/2010SLR26292056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021083s046,021110s056lbl.pdf 8/27/2010
AP011/23/2010SLR27218057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021110s057lbl.pdf 11/23/2010
AP011/23/2010SLR27250057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021110s055s057,021083s044,s047ltr.pdf 12/7/2010
AP011/8/2010SLR26910058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021110s058lbl.pdf 11/4/2010
AP011/8/2010SLR27012058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021083s048,021110s058ltr.pdf 11/24/2010
AP07/11/2011SLR29505059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021083s049,021110s059ltr.pdf 7/13/2011
AP06/6/2011SLR29084060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021083s050,021110s060ltr.pdf 6/9/2011
AP012/10/2012SLR34600065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021083Orig1s051,021110Orig1s065ltr.pdf 12/11/2012
AP012/10/2012SLR34666065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021083s051,021110s065lbl.pdf 12/14/2012
AP03/7/2013SLR35372067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021083Orig1s053,021110Orig1s067ltr.pdf 3/8/2013
AP03/7/2013SLR35375067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021083s053,021110s067lbl.pdf 3/8/2013
AP05/30/2013SLR37103068   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021110s068lbl.pdf 9/17/2013
AP05/30/2013SLR37133068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021110Orig1s068,021083Orig1s054ltr.pdf 9/17/2013
AP011/6/2013SCM       
AP01/29/2014SCM       
AP07/3/2014SCM       
AP03/30/2015SCM       
AP05/28/2015SE842948073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021083Orig1s055,021110Orig1s073ltr.pdf 5/29/2015
AP05/28/2015SE842954073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s055,021110s073lbl.pdf 6/1/2015
AP03/6/2015SLR42061074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s056,021110s074lbl.pdf 3/9/2015
AP03/6/2015SLR42074074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021083Orig1s056,021110Orig1s074ltr.pdf 3/10/2015
AP011/5/2015SLR44427075   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021083Orig1s058,021110Orig1075ltr.pdf 11/9/2015
AP011/5/2015SLR44439075   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021083s058,021110s075lbl.pdf 11/12/2015




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