SANOFI AVENTIS US FDA Approval NDA 022064

NDA 022064

SANOFI AVENTIS US

FDA Drug Application

Application #022064

Documents

Letter2008-04-09
Letter2008-02-05
Letter2009-11-10
Letter2011-03-10
Letter2012-09-07
Letter2013-11-08
Label2008-04-09
Label2008-02-14
Label2008-04-01
Label2011-03-07
Letter2008-04-02
Letter2016-06-24
Label2009-10-06
Label2012-09-11
Label2013-11-08
Label2016-06-27
Review2008-10-15
Summary Review2008-10-15
Label2016-11-09
Letter2016-11-09
Label2017-02-10
Letter2017-02-16
Label2017-07-13
Letter2017-07-13
Label2017-10-17
Letter2017-10-19
Pediatric Written Request2009-08-25
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Label2018-04-03
Letter2018-04-03
Label2019-01-16
Letter2019-01-18
Label2019-04-03
Letter2019-04-04

Application Sponsors

NDA 022064SANOFI AVENTIS US

Marketing Status

Prescription001

Application Products

001TABLET;ORAL5MG1XYZALLEVOCETIRIZINE DIHYDROCHLORIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2007-05-25PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2007-10-18N/A
LABELING; LabelingSUPPL5AP2008-02-01STANDARD
LABELING; LabelingSUPPL9AP2008-03-31STANDARD
EFFICACY; EfficacySUPPL17AP2009-08-21PRIORITY
LABELING; LabelingSUPPL20AP2011-03-07STANDARD
LABELING; LabelingSUPPL24AP2012-09-06STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL26AP2012-11-20PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL27AP2014-02-14PRIORITY
LABELING; LabelingSUPPL28AP2013-11-07STANDARD
LABELING; LabelingSUPPL30AP2016-06-23STANDARD
LABELING; LabelingSUPPL31AP2017-02-09STANDARD
LABELING; LabelingSUPPL32AP2016-11-08STANDARD
LABELING; LabelingSUPPL33AP2017-07-10STANDARD
LABELING; LabelingSUPPL34AP2017-10-16STANDARD
LABELING; LabelingSUPPL36AP2018-04-02STANDARD
LABELING; LabelingSUPPL37AP2019-01-11STANDARD
LABELING; LabelingSUPPL38AP2019-04-02STANDARD

Submissions Property Types

ORIG1Null31
SUPPL17Null8
SUPPL20Null6
SUPPL24Null7
SUPPL26Null0
SUPPL27Null0
SUPPL28Null15
SUPPL30Null15
SUPPL31Null6
SUPPL32Null6
SUPPL33Null6
SUPPL34Null7
SUPPL36Null6
SUPPL37Null7
SUPPL38Null15

TE Codes

001PrescriptionAB

CDER Filings

SANOFI AVENTIS US
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22064
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"XYZAL","activeIngredients":"LEVOCETIRIZINE DIHYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/02\/2019","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022064s038,022157s020lbl.pdf\"}]","notes":""},{"actionDate":"01\/11\/2019","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022064s037,022157s019lbl.pdf\"}]","notes":""},{"actionDate":"04\/02\/2018","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022064s036lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2017","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022064s034lbl.pdf\"}]","notes":""},{"actionDate":"07\/10\/2017","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022064s033,022157s016lbl.pdf\"}]","notes":""},{"actionDate":"02\/09\/2017","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022064s031,022157s014lbl.pdf\"}]","notes":""},{"actionDate":"11\/08\/2016","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022064s032_022157s015lbl.pdf\"}]","notes":""},{"actionDate":"06\/23\/2016","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022064s030,022157s013lbl.pdf\"}]","notes":""},{"actionDate":"11\/07\/2013","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022064s028_022157s012lbl.pdf\"}]","notes":""},{"actionDate":"09\/06\/2012","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022064s024,022157s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/07\/2011","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022064s020,022157s007lbl.pdf\"}]","notes":""},{"actionDate":"08\/21\/2009","submission":"SUPPL-17","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022064s017,022157s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/31\/2008","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022064s009lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2008","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022064s005lbl.pdf\"}]","notes":""},{"actionDate":"05\/25\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/022064lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"XYZAL","submission":"LEVOCETIRIZINE DIHYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-04-02
        )

)
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