SANOFI AVENTIS US FDA Approval NDA 020449

NDA 020449

SANOFI AVENTIS US

FDA Drug Application

Application #020449

Documents

Letter1998-06-22
Letter2003-01-30
Letter2002-11-27
Letter2004-08-25
Letter2005-01-11
Letter2005-11-18
Letter2006-04-05
Letter2006-10-23
Letter2010-04-23
Letter2010-05-18
Letter2011-09-12
Letter2011-12-20
Letter2013-12-16
Letter2014-11-17
Label2002-11-27
Label2004-06-18
Label2004-05-19
Label2006-04-05
Label2006-10-18
Label2010-05-03
Label2007-10-04
Label2010-05-03
Label2015-04-14
Label2011-09-16
Label2013-07-08
Label2013-12-17
Label2014-11-20
Label2015-12-15
Review2001-07-05
Review2005-04-15
Review2014-07-07
Review2016-07-27
Letter1998-06-22
Letter1999-12-23
Letter2003-05-29
Letter2003-01-30
Letter2003-01-30
Letter2004-05-26
Letter2005-08-15
Letter2006-06-08
Letter2010-06-08
Letter2007-10-04
Letter2010-04-23
Letter2013-06-27
Letter2015-12-15
Label1999-12-23
Label2003-04-28
Label2004-06-18
Label2003-01-30
Label2004-08-19
Label2005-08-15
Label2006-06-08
Label2010-05-17
Label2011-12-20
Review2000-07-11
Review2003-07-08
Review2005-04-27
Review2011-09-22
Review2014-07-07
Review2012-10-15
Patient Information Sheet2006-06-08
Pediatric Written Request2007-06-11
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Label2018-10-09
Letter2018-10-15
Review1996-05-14
Pediatric Written Request1900-01-01
Review2019-06-03
Label2019-06-07
Label2019-06-07
Letter2019-06-07
Letter2019-06-07
Label2019-12-18
Letter2019-12-20
Letter2020-05-19
Label2020-05-19
Review2020-07-22
Review2020-07-22
Label2022-06-13
Letter2022-06-14
Letter2023-01-19
Label2023-01-25

Application Sponsors

NDA 020449SANOFI AVENTIS US

Marketing Status

Discontinued001
Prescription003
Prescription004
Prescription005

Application Products

001INJECTABLE;INJECTION40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1TAXOTEREDOCETAXEL
003INJECTABLE;INJECTION20MG/ML (20MG/ML)1TAXOTEREDOCETAXEL
004INJECTABLE;INJECTION80MG/4ML (20MG/ML)1TAXOTEREDOCETAXEL
005INJECTABLE;INJECTION160MG/8ML (20MG/ML)1TAXOTEREDOCETAXEL

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1996-05-14PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1999-11-22PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1998-05-15PRIORITY
LABELING; LabelingSUPPL4AP1998-01-06STANDARD
EFFICACY; EfficacySUPPL5AP1998-06-22PRIORITY
LABELING; LabelingSUPPL6AP1998-06-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1999-02-23PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1999-12-06PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1999-05-18PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1999-03-31PRIORITY
EFFICACY; EfficacySUPPL11AP1999-12-23PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2000-09-28PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2000-09-28PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2000-11-30PRIORITY
LABELING; LabelingSUPPL16AP2003-04-24STANDARD
LABELING; LabelingSUPPL17AP2002-07-09STANDARD
EFFICACY; EfficacySUPPL18AP2002-11-27STANDARD
LABELING; LabelingSUPPL19AP2002-07-30STANDARD
LABELING; LabelingSUPPL22AP2003-01-30STANDARD
EFFICACY; EfficacySUPPL28AP2004-05-19PRIORITY
EFFICACY; EfficacySUPPL29AP2004-08-18PRIORITY
LABELING; LabelingSUPPL31AP2005-01-06STANDARD
LABELING; LabelingSUPPL33AP2005-08-11STANDARD
LABELING; LabelingSUPPL34AP2005-11-05STANDARD
EFFICACY; EfficacySUPPL35AP2006-03-22PRIORITY
LABELING; LabelingSUPPL36AP2006-06-07STANDARD
EFFICACY; EfficacySUPPL39AP2006-10-17PRIORITY
LABELING; LabelingSUPPL43AP2010-06-03STANDARD
LABELING; LabelingSUPPL44AP2010-04-20STANDARD
EFFICACY; EfficacySUPPL45AP2007-09-28PRIORITY
LABELING; LabelingSUPPL53AP2010-04-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL54AP2010-08-02N/A
EFFICACY; EfficacySUPPL59AP2010-05-13PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL63AP2012-04-13N/A
LABELING; LabelingSUPPL64AP2011-09-07STANDARD
LABELING; LabelingSUPPL65AP2011-12-15UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL68AP2012-11-21PRIORITY
LABELING; LabelingSUPPL69AP2013-06-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL70AP2013-08-15PRIORITY
LABELING; LabelingSUPPL71AP2013-12-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL72AP2014-05-15PRIORITY
LABELING; LabelingSUPPL73AP2014-11-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL74AP2016-05-17PRIORITY
LABELING; LabelingSUPPL75AP2015-12-11STANDARD
LABELING; LabelingSUPPL79AP2018-10-05STANDARD
LABELING; LabelingSUPPL80AP2019-06-06STANDARD
LABELING; LabelingSUPPL82AP2019-06-06STANDARD
LABELING; LabelingSUPPL83AP2019-12-17STANDARD
LABELING; LabelingSUPPL84AP2020-05-15STANDARD
LABELING; LabelingSUPPL85AP2022-04-27STANDARD
LABELING; LabelingSUPPL86AP2023-01-18STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL5Null41
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL43Null7
SUPPL44Null6
SUPPL53Null7
SUPPL59Null7
SUPPL63Null15
SUPPL64Null15
SUPPL65Null15
SUPPL68Null0
SUPPL69Null15
SUPPL70Null0
SUPPL71Null15
SUPPL72Null0
SUPPL73Null6
SUPPL74Null0
SUPPL75Null15
SUPPL79Null15
SUPPL80Null6
SUPPL82Null6
SUPPL83Null6
SUPPL84Null7
SUPPL85Null15
SUPPL86Null6

TE Codes

003PrescriptionAP
004PrescriptionAP
005PrescriptionAP

CDER Filings

SANOFI AVENTIS US
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20449
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"TAXOTERE","activeIngredients":"DOCETAXEL","strength":"40MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"TAXOTERE","activeIngredients":"DOCETAXEL","strength":"20MG\/ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"TAXOTERE","activeIngredients":"DOCETAXEL","strength":"80MG\/4ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"TAXOTERE","activeIngredients":"DOCETAXEL","strength":"160MG\/8ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/15\/2020","submission":"SUPPL-84","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020449s084lbl.pdf\"}]","notes":""},{"actionDate":"12\/17\/2019","submission":"SUPPL-83","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020449s083lbl.pdf\"}]","notes":""},{"actionDate":"06\/06\/2019","submission":"SUPPL-82","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020449s080s082lbl.pdf\"}]","notes":""},{"actionDate":"06\/06\/2019","submission":"SUPPL-80","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020449s080s082lbl.pdf\"}]","notes":""},{"actionDate":"10\/05\/2018","submission":"SUPPL-79","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020449s079lbl.pdf\"}]","notes":""},{"actionDate":"12\/11\/2015","submission":"SUPPL-75","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020449s075lbl.pdf\"}]","notes":""},{"actionDate":"12\/11\/2015","submission":"SUPPL-75","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020449s075lbl.pdf\"}]","notes":""},{"actionDate":"11\/14\/2014","submission":"SUPPL-73","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020449s073lbl.pdf\"}]","notes":""},{"actionDate":"12\/13\/2013","submission":"SUPPL-71","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020449s071lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2013","submission":"SUPPL-69","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020449s069lbl.pdf\"}]","notes":""},{"actionDate":"04\/13\/2012","submission":"SUPPL-63","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020449s063lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2011","submission":"SUPPL-65","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020449s065lbl.pdf\"}]","notes":""},{"actionDate":"09\/07\/2011","submission":"SUPPL-64","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020449s064lbl.pdf\"}]","notes":""},{"actionDate":"05\/13\/2010","submission":"SUPPL-59","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020449s059lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2010","submission":"SUPPL-53","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020449s053lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2010","submission":"SUPPL-44","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020449s044lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2007","submission":"SUPPL-45","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020449s045lbl.pdf\"}]","notes":""},{"actionDate":"10\/17\/2006","submission":"SUPPL-39","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020449s039lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2006","submission":"SUPPL-36","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020449s036lbl.pdf\"}]","notes":""},{"actionDate":"03\/22\/2006","submission":"SUPPL-35","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020449S035lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2005","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020449s033lbl.pdf\"}]","notes":""},{"actionDate":"08\/18\/2004","submission":"SUPPL-29","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/020449s029lbl.pdf\"}]","notes":""},{"actionDate":"05\/19\/2004","submission":"SUPPL-28","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/020449s028lbl.pdf\"}]","notes":""},{"actionDate":"04\/24\/2003","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/020449s016lbl.pdf\"}]","notes":""},{"actionDate":"01\/30\/2003","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20449slr022_taxotere_lbl.pdf\"}]","notes":""},{"actionDate":"11\/27\/2002","submission":"SUPPL-18","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20449se1-018_Taxotere_lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2002","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20449slr022_taxotere_lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2002","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20449slr022_taxotere_lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/1999","submission":"SUPPL-11","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/20449S11LBL.PDF\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TAXOTERE","submission":"DOCETAXEL","actionType":"40MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"TAXOTERE","submission":"DOCETAXEL","actionType":"20MG\/ML (20MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TAXOTERE","submission":"DOCETAXEL","actionType":"80MG\/4ML (20MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TAXOTERE","submission":"DOCETAXEL","actionType":"160MG\/8ML (20MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-05-15
        )

)
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