FDA.reportPublic FDA data

Application 021083

Type
NDA
Sponsor
PF PRISM CV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RAPAMUNESIROLIMUSSOLUTION;ORAL1MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0008-1030RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1030RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1030RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1030RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1030RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1030RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1030RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1030RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1030RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
0008-1030RapamuneSIROLIMUSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.NDACurrent
59762-1205SirolimussirolimusGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1205SirolimussirolimusGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1205SirolimussirolimusGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1205SirolimussirolimusGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1205SirolimussirolimusGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-1205SirolimussirolimusGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71868SUPPL2022-08-23
71867SUPPL2022-08-23
71866SUPPL2022-08-23
71860SUPPL2022-08-23
71859SUPPL2022-08-23
61520SUPPL2020-01-06
61519SUPPL2020-01-06
61507SUPPL2020-01-03
59626SUPPL2019-08-08
59354SUPPL2019-07-16
59353SUPPL2019-07-16
59344SUPPL2019-07-16
59119SUPPL2019-06-19
58254SUPPL2019-04-08
58252SUPPL2019-04-08
58249SUPPL2019-04-08
54343SUPPL2018-05-25
54336SUPPL2018-05-24
51061SUPPL2018-01-17
51055SUPPL2018-01-16
51052SUPPL2018-01-16
47992SUPPL2017-04-12
14334SUPPL2015-11-12
4265SUPPL2015-11-09
36060SUPPL2015-06-01
4263SUPPL2015-05-29
4264SUPPL2015-03-10
14333SUPPL2015-03-09
4262SUPPL2013-09-17
36059SUPPL2013-03-08
4261SUPPL2013-03-08
14332SUPPL2012-12-14
26698SUPPL2012-12-11
4259SUPPL2011-07-13
4260SUPPL2011-06-09
4258SUPPL2010-12-07
4256SUPPL2010-12-07
36057SUPPL2010-12-01
36055SUPPL2010-12-01
26697SUPPL2010-11-08
36058SUPPL2010-11-04
14331SUPPL2010-08-27
4257SUPPL2010-07-08
14330SUPPL2010-05-03
14329SUPPL2010-05-03
26695SUPPL2010-04-28
26694SUPPL2010-04-28
36056SUPPL2010-02-04
26696SUPPL2010-02-01
26693SUPPL2009-11-10
4255SUPPL2009-11-10
36054SUPPL2009-10-14
14328SUPPL2009-10-01
21429SUPPL2009-09-14
14327SUPPL2009-02-04
26692SUPPL2008-03-10
36053SUPPL2008-03-07
14326SUPPL2008-03-07
4254SUPPL2008-03-07
26691SUPPL2008-01-18
14324SUPPL2008-01-18
14325SUPPL2007-10-22
4253SUPPL2007-10-22
4252SUPPL2007-05-09
36052SUPPL2007-05-07
4250SUPPL2007-02-12
4251SUPPL2007-01-25
36051SUPPL2007-01-16
14323SUPPL2007-01-16
4249SUPPL2007-01-16
36050SUPPL2006-10-23
36049SUPPL2006-06-06
26690SUPPL2006-06-06
14322SUPPL2006-06-06
4248SUPPL2006-06-06
36048SUPPL2005-10-14
26689SUPPL2005-10-14
14321SUPPL2005-10-14
4247SUPPL2005-10-14
26688SUPPL2005-07-08
4246SUPPL2005-07-08
14320SUPPL2005-07-07
14319SUPPL2005-07-07
36047SUPPL2005-03-14
26687SUPPL2005-03-14
36046SUPPL2004-07-21
26686SUPPL2004-07-21
4245SUPPL2004-06-14
14318SUPPL2003-10-10
26685SUPPL2003-10-09
4243SUPPL2003-04-18
36042SUPPL2003-04-11
36045SUPPL2003-03-26
36044SUPPL2003-01-23
36043SUPPL2003-01-23
26684SUPPL2003-01-23
26683SUPPL2003-01-23
26682SUPPL2003-01-23
26681SUPPL2003-01-23
14317SUPPL2003-01-23