PF PRISM CV FDA Approval NDA 022088

NDA 022088

PF PRISM CV

FDA Drug Application

Application #022088

Documents

Letter2007-06-04
Letter2007-11-19
Letter2011-06-27
Letter2010-04-29
Letter2011-06-27
Letter2010-07-14
Letter2011-06-27
Letter2012-06-04
Label2007-06-04
Label2007-11-19
Label2010-04-28
Label2010-07-12
Label2014-10-09
Label2015-03-02
Label2016-07-28
Letter2011-06-27
Letter2011-06-27
Letter2011-06-27
Letter2014-04-08
Letter2014-10-09
Letter2015-02-27
Letter2016-07-28
Label2011-06-16
Label2011-06-16
Label2011-06-16
Label2011-06-16
Label2011-06-16
Label2011-06-16
Label2012-06-06
Label2014-04-08
Review2007-07-30
Letter2017-05-24
Label2017-05-24
Pediatric Written Request2012-02-28
Pediatric Amendment 12012-02-28
Pediatric Amendment 22012-02-28
Pediatric Amendment 32012-02-28
Pediatric Amendment 42012-02-28
Pediatric Amendment 52012-02-28
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Label2018-03-27
Label2018-03-27
Letter2018-03-29
Letter2018-03-29

Application Sponsors

NDA 022088PF PRISM CV

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUS25MG/ML (25MG/ML)1TORISELTEMSIROLIMUS

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2007-05-30PRIORITY
LABELING; LabelingSUPPL2AP2011-06-16STANDARD
LABELING; LabelingSUPPL4AP2011-06-16STANDARD
LABELING; LabelingSUPPL5AP2011-06-16STANDARD
EFFICACY; EfficacySUPPL6AP2010-04-26STANDARD
LABELING; LabelingSUPPL7AP2011-06-16STANDARD
EFFICACY; EfficacySUPPL8AP2010-07-09STANDARD
LABELING; LabelingSUPPL10AP2011-06-16UNKNOWN
LABELING; LabelingSUPPL12AP2011-06-16UNKNOWN
EFFICACY; EfficacySUPPL14AP2012-05-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2013-12-20PRIORITY
LABELING; LabelingSUPPL16AP2014-04-07STANDARD
LABELING; LabelingSUPPL17AP2014-10-07STANDARD
LABELING; LabelingSUPPL18AP2015-02-26STANDARD
LABELING; LabelingSUPPL19AP2016-07-27STANDARD
LABELING; LabelingSUPPL20AP2017-05-22STANDARD
LABELING; LabelingSUPPL21AP2018-03-23STANDARD
LABELING; LabelingSUPPL23AP2018-03-23STANDARD

Submissions Property Types

ORIG1Null2
SUPPL2Null6
SUPPL4Null7
SUPPL5Null6
SUPPL6Null6
SUPPL7Null7
SUPPL8Null7
SUPPL10Null7
SUPPL12Null7
SUPPL14Null7
SUPPL15Null0
SUPPL16Null6
SUPPL17Null6
SUPPL18Null7
SUPPL19Null15
SUPPL20Null6
SUPPL21Null6
SUPPL23Null15

TE Codes

001PrescriptionAP

CDER Filings

PF PRISM CV
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22088
            [companyName] => PF PRISM CV
            [docInserts] => ["",""]
            [products] => [{"drugName":"TORISEL","activeIngredients":"TEMSIROLIMUS","strength":"25MG\/ML (25MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/23\/2018","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022088s021s023lbl.pdf\"}]","notes":""},{"actionDate":"03\/23\/2018","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022088s021s023lbl.pdf\"}]","notes":""},{"actionDate":"05\/22\/2017","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022088s020lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2016","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022088s019lbl.pdf\"}]","notes":""},{"actionDate":"02\/26\/2015","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022088s018lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2014","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022088s017lbl.pdf\"}]","notes":""},{"actionDate":"04\/07\/2014","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022088s016lbl.pdf\"}]","notes":""},{"actionDate":"05\/30\/2012","submission":"SUPPL-14","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022088s014lbl.pdf\"}]","notes":""},{"actionDate":"06\/16\/2011","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022088s002s004s005s007s010s012lbl.pdf\"}]","notes":""},{"actionDate":"06\/16\/2011","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022088s002s004s005s007s010s012lbl.pdf\"}]","notes":""},{"actionDate":"06\/16\/2011","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022088s002s004s005s007s010s012lbl.pdf\"}]","notes":""},{"actionDate":"06\/16\/2011","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022088s002s004s005s007s010s012lbl.pdf\"}]","notes":""},{"actionDate":"06\/16\/2011","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022088s002s004s005s007s010s012lbl.pdf\"}]","notes":""},{"actionDate":"06\/16\/2011","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022088s002s004s005s007s010s012lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2010","submission":"SUPPL-8","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022088s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2010","submission":"SUPPL-6","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022088s006lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2007","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022088s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/30\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022088lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TORISEL","submission":"TEMSIROLIMUS","actionType":"25MG\/ML (25MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-03-23
        )

)
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