SANOFI AVENTIS US FDA Approval NDA 020905

NDA 020905

SANOFI AVENTIS US

FDA Drug Application

Application #020905

Documents

Letter2003-06-22
Letter2005-10-25
Letter2007-11-19
Letter2009-04-07
Letter2010-09-13
Letter2014-11-18
Label1998-09-10
Label2003-06-22
Label2007-11-13
Label2010-09-10
Label2012-11-06
Label2015-09-03
Review2007-11-19
Review2007-11-19
Letter1998-09-10
Letter2003-06-22
Letter2004-03-10
Letter2004-12-02
Letter2011-07-12
Letter2012-11-06
Letter2015-09-01
Label2003-06-22
Label2004-04-05
Label2004-12-03
Label2005-10-25
Label2011-07-12
Review2008-07-31
Letter2016-10-20
Label2017-02-22
Pediatric Written Request1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Medical Addendum1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Pediatric Statistical Review1900-01-01

Application Sponsors

NDA 020905SANOFI AVENTIS US

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL10MG1ARAVALEFLUNOMIDE
002TABLET;ORAL20MG1ARAVALEFLUNOMIDE
003TABLET;ORAL100MG1ARAVALEFLUNOMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1998-09-10PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1999-07-20PRIORITY
LABELING; LabelingSUPPL3AP2000-02-23STANDARD
LABELING; LabelingSUPPL4AP2000-02-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2000-09-21PRIORITY
EFFICACY; EfficacySUPPL6AP2003-06-13PRIORITY
LABELING; LabelingSUPPL7AP2003-06-13STANDARD
EFFICACY; EfficacySUPPL12AP2004-03-05PRIORITY
LABELING; LabelingSUPPL14AP2004-11-22STANDARD
LABELING; LabelingSUPPL15AP2005-10-19STANDARD
LABELING; LabelingSUPPL16AP2007-11-08STANDARD
LABELING; LabelingSUPPL18AP2009-04-03STANDARD
LABELING; LabelingSUPPL20AP2010-09-09901 REQUIRED
LABELING; LabelingSUPPL22AP2011-07-08STANDARD
LABELING; LabelingSUPPL25AP2012-11-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL26AP2015-04-29PRIORITY
LABELING; LabelingSUPPL27AP2015-08-28STANDARD
LABELING; LabelingSUPPL28AP2014-11-14STANDARD
LABELING; LabelingSUPPL31AP2016-10-18STANDARD

Submissions Property Types

ORIG1Null10
SUPPL2Null0
SUPPL5Null0
SUPPL12Null6
SUPPL20Null7
SUPPL22Null7
SUPPL25Null6
SUPPL26Null0
SUPPL27Null15
SUPPL28Null6
SUPPL31Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

SANOFI AVENTIS US
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20905
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARAVA","activeIngredients":"LEFLUNOMIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ARAVA","activeIngredients":"LEFLUNOMIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ARAVA","activeIngredients":"LEFLUNOMIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/18\/2016","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020905s031lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2015","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020905s027lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2012","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020905s025lbl.pdf\"}]","notes":""},{"actionDate":"07\/08\/2011","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020905s022lbl.pdf\"}]","notes":""},{"actionDate":"09\/09\/2010","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020905s020lbl.pdf\"}]","notes":""},{"actionDate":"11\/08\/2007","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020905s016lbl.pdf\"}]","notes":""},{"actionDate":"10\/19\/2005","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020905s015lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2004","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20905s014lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2004","submission":"SUPPL-12","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20905se5-012_Arava_lbl.pdf\"}]","notes":""},{"actionDate":"06\/13\/2003","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20905slr007,20905se1-006_arava_lbl.pdf\"}]","notes":""},{"actionDate":"06\/13\/2003","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20905slr007,20905se1-006_arava_lbl.pdf\"}]","notes":""},{"actionDate":"09\/10\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20905lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ARAVA","submission":"LEFLUNOMIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ARAVA","submission":"LEFLUNOMIDE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ARAVA","submission":"LEFLUNOMIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2016-10-18
        )

)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.