SANOFI AVENTIS US FDA Approval NDA 201023

NDA 201023

SANOFI AVENTIS US

FDA Drug Application

Application #201023

Documents

Letter2010-06-21
Letter2012-10-09
Label2010-06-17
Label2012-10-05
Label2015-06-19
Review2010-07-30
Letter2013-04-30
Letter2014-11-21
Letter2015-06-22
Label2014-11-20
Summary Review2010-07-30
Letter2016-09-15
Label2016-09-15
Label2017-05-18
Letter2017-05-19
Label2017-09-14
Letter2017-09-19
Label2018-01-10
Letter2018-01-11
Pediatric Written Request2012-03-20
Pediatric Amendment 12013-05-08
Pediatric Amendment 22015-03-03
Pediatric Medical Review1900-01-01
Label2020-03-06
Letter2020-12-22
Label2020-12-22
Letter2021-02-17
Label2021-02-19

Application Sponsors

NDA 201023SANOFI AVENTIS US

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUS60MG/1.5ML (40MG/ML)1JEVTANA KITCABAZITAXEL

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2010-06-17PRIORITY
LABELING; LabelingSUPPL3AP2012-10-04STANDARD
LABELING; LabelingSUPPL7AP2013-04-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2013-03-13PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2013-09-11PRIORITY
LABELING; LabelingSUPPL10AP2014-03-14STANDARD
LABELING; LabelingSUPPL11AP2014-11-19STANDARD
LABELING; LabelingSUPPL12AP2014-03-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2015-01-05PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2015-06-11PRIORITY
LABELING; LabelingSUPPL15AP2015-06-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2016-05-27PRIORITY
LABELING; LabelingSUPPL17AP2016-09-12STANDARD
EFFICACY; EfficacySUPPL19AP2017-09-14STANDARD
EFFICACY; EfficacySUPPL20AP2017-05-17PRIORITY
LABELING; LabelingSUPPL21AP2018-01-09STANDARD
LABELING; LabelingSUPPL23AP2020-03-05STANDARD
EFFICACY; EfficacySUPPL24AP2020-12-18PRIORITY
LABELING; LabelingSUPPL25AP2021-02-12STANDARD

Submissions Property Types

ORIG1Null6
SUPPL3Null7
SUPPL7Null15
SUPPL8Null0
SUPPL9Null0
SUPPL10Null6
SUPPL11Null6
SUPPL12Null6
SUPPL13Null0
SUPPL14Null0
SUPPL15Null15
SUPPL16Null0
SUPPL17Null15
SUPPL19Null7
SUPPL20Null8
SUPPL21Null6
SUPPL23Null15
SUPPL24Null6
SUPPL25Null15

TE Codes

001PrescriptionAP

CDER Filings

SANOFI AVENTIS US
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201023
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"JEVTANA KIT","activeIngredients":"CABAZITAXEL","strength":"60MG\/1.5ML (40MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/05\/2020","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/201023s023lbl.pdf\"}]","notes":""},{"actionDate":"01\/09\/2018","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/201023s021lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2017","submission":"SUPPL-19","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201023s019lbl.pdf\"}]","notes":""},{"actionDate":"05\/17\/2017","submission":"SUPPL-20","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201023s020lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2016","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201023s017lbl.pdf\"}]","notes":""},{"actionDate":"06\/18\/2015","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/201023s015lbl.pdf\"}]","notes":""},{"actionDate":"11\/19\/2014","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201023s011lbl.pdf\"}]","notes":""},{"actionDate":"10\/04\/2012","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/201023s003lbl.pdf\"}]","notes":""},{"actionDate":"06\/17\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/201023lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/17\/2010","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/201023lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/201023s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2010\\\/201023s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2010\\\/201023s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"03\/05\/2020","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/201023s023lbl.pdf\"}]","notes":">"},{"actionDate":"01\/09\/2018","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/201023s021lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/201023Orig1s021ltr.pdf\"}]","notes":">"},{"actionDate":"05\/17\/2017","submission":"SUPPL-20","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201023s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/201023Orig1sS020ltr.pdf\"}]","notes":">"},{"actionDate":"09\/14\/2017","submission":"SUPPL-19","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201023s019lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/201023Orig1s019ltr.pdf\"}]","notes":">"},{"actionDate":"09\/12\/2016","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201023s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/201023Orig1s017ltr.pdf\"}]","notes":">"},{"actionDate":"05\/27\/2016","submission":"SUPPL-16","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/18\/2015","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/201023s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/201023Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"06\/11\/2015","submission":"SUPPL-14","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/05\/2015","submission":"SUPPL-13","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/14\/2014","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/19\/2014","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/201023s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/201023Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"03\/14\/2014","submission":"SUPPL-10","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/11\/2013","submission":"SUPPL-9","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/13\/2013","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/25\/2013","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/201023Orig1s007ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"10\/04\/2012","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/201023s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/201023Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-03-05
        )

)
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