FDA.reportPublic FDA data

Application 021110

Type
NDA
Sponsor
PF PRISM CV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RAPAMUNESIROLIMUSTABLET;ORAL1MGYesNo
002RAPAMUNESIROLIMUSTABLET;ORAL2MGYesYes
003RAPAMUNESIROLIMUSTABLET;ORAL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004RAPAMUNESIROLIMUSTABLET;ORAL0.5MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0008-1040RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1040RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1040RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1040RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1040RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1040RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1040RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1040RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1040RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1040RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1041RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1041RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1041RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1041RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1041RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1041RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1041RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1041RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1041RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1041RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1042RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1042RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1042RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1042RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1042RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1042RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1042RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1042RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1042RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1042RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
59762-1001SirolimusSIROLIMUSGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1001SirolimusSIROLIMUSGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1001SirolimusSIROLIMUSGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1001SirolimusSIROLIMUSGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1002SirolimusSIROLIMUSGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1002SirolimusSIROLIMUSGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1002SirolimusSIROLIMUSGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1002SirolimusSIROLIMUSGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1003SirolimusSIROLIMUSGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1003SirolimusSIROLIMUSGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1003SirolimusSIROLIMUSGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1003SirolimusSIROLIMUSGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71871SUPPL2022-08-23
71870SUPPL2022-08-23
71869SUPPL2022-08-23
71862SUPPL2022-08-23
71861SUPPL2022-08-23
69126SUPPL2021-10-26
69125SUPPL2021-10-26
68323SUPPL2021-08-10
61522SUPPL2020-01-06
61521SUPPL2020-01-06
61508SUPPL2020-01-03
59356SUPPL2019-07-16
59355SUPPL2019-07-16
59345SUPPL2019-07-16
58256SUPPL2019-04-09
58251SUPPL2019-04-08
58250SUPPL2019-04-08
54345SUPPL2018-05-25
54344SUPPL2018-05-25
54335SUPPL2018-05-24
51062SUPPL2018-01-17
51053SUPPL2018-01-16
47994SUPPL2017-04-12
36146SUPPL2015-11-12
26800SUPPL2015-11-09
14414SUPPL2015-06-01
26798SUPPL2015-05-29
26799SUPPL2015-03-10
14415SUPPL2015-03-09
36145SUPPL2013-09-17
26797SUPPL2013-09-17
14413SUPPL2013-03-08
4364SUPPL2013-03-08
36144SUPPL2012-12-14
4363SUPPL2012-12-11
26796SUPPL2011-07-13
4362SUPPL2011-06-09
4361SUPPL2010-12-07
4359SUPPL2010-12-07
26795SUPPL2010-11-24
36142SUPPL2010-11-23
36141SUPPL2010-11-23
36143SUPPL2010-11-04
14412SUPPL2010-08-27
4360SUPPL2010-07-08
36140SUPPL2010-05-03
14411SUPPL2010-05-03
26794SUPPL2010-04-28
4358SUPPL2010-04-28
14410SUPPL2010-02-04
26793SUPPL2010-02-01
26792SUPPL2009-11-10
4357SUPPL2009-11-10
14409SUPPL2009-10-14
36139SUPPL2009-10-01
41955SUPPL2009-09-14
36138SUPPL2009-02-04
4356SUPPL2009-02-03
4355SUPPL2008-03-10
26791SUPPL2008-03-07
36137SUPPL2008-01-18
26790SUPPL2008-01-18
14408SUPPL2007-10-22
4354SUPPL2007-10-22
26789SUPPL2007-05-09
36136SUPPL2007-05-07
4353SUPPL2007-02-12
26788SUPPL2007-01-25
14407SUPPL2007-01-16
14405SUPPL2007-01-16
4352SUPPL2007-01-16
14406SUPPL2006-10-23
36135SUPPL2006-06-06
26787SUPPL2006-06-06
14404SUPPL2006-06-06
4351SUPPL2006-06-06
36134SUPPL2005-10-14
26786SUPPL2005-10-14
14403SUPPL2005-10-14
4350SUPPL2005-10-14
26785SUPPL2005-07-08
4349SUPPL2005-07-08
36133SUPPL2005-07-07
14402SUPPL2005-07-07
36132SUPPL2005-03-14
26784SUPPL2005-03-14
36131SUPPL2004-07-21
26783SUPPL2004-07-21
26779SUPPL2004-06-14
36130SUPPL2004-04-05
26782SUPPL2004-03-02
36129SUPPL2003-10-10
26781SUPPL2003-10-02
4347SUPPL2003-04-18
14397SUPPL2003-04-11
26780SUPPL2003-03-28
14401SUPPL2003-03-28
14400SUPPL2003-03-21
36128SUPPL2003-01-31
36127SUPPL2003-01-23