SANOFI AVENTIS US FDA Approval NDA 022425

NDA 022425

SANOFI AVENTIS US

FDA Drug Application

Application #022425

Documents

Letter2011-08-11
Letter2011-06-27
Letter2011-09-06
Letter2012-09-10
Letter2013-03-29
Letter2014-03-20
Letter2014-02-04
Letter2014-04-03
Letter2016-02-16
Label2011-01-31
Label2011-06-29
Label2011-12-19
Label2012-06-18
Label2012-09-11
Label2013-04-01
Label2014-06-23
Review2009-08-20
Medication Guide2009-11-19
Letter2009-07-30
Letter2011-02-15
Letter2012-01-30
Letter2011-02-04
Letter2011-02-15
Letter2011-03-14
Letter2011-12-21
Letter2012-06-15
Letter2012-09-10
Letter2012-09-10
Label2009-07-06
Label2011-02-24
Label2012-01-31
Label2011-03-11
Label2011-09-07
Label2012-09-11
Label2012-09-11
Label2014-01-31
Summary Review2009-08-20
Medication Guide2018-11-08
Letter2020-11-17
Label2020-11-18
Medication Guide2020-12-09

Application Sponsors

NDA 022425SANOFI AVENTIS US

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 400MG BASE1MULTAQDRONEDARONE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2009-07-01PRIORITY
LABELING; LabelingSUPPL2AP2012-01-25UNKNOWN
LABELING; LabelingSUPPL4AP2011-01-31UNKNOWN
LABELING; LabelingSUPPL5AP2011-02-11UNKNOWN
REMS; REMSSUPPL6AP2011-08-05N/A
LABELING; LabelingSUPPL7AP2011-03-11UNKNOWN
LABELING; LabelingSUPPL10AP2011-06-21UNKNOWN
LABELING; LabelingSUPPL12AP2011-08-22UNKNOWN
LABELING; LabelingSUPPL13AP2011-12-19UNKNOWN
REMS; REMSSUPPL14AP2012-06-13N/A
LABELING; LabelingSUPPL16AP2012-09-07UNKNOWN
REMS; REMSSUPPL17AP2012-09-07N/A
LABELING; LabelingSUPPL18AP2012-09-07UNKNOWN
LABELING; LabelingSUPPL21AP2013-03-27STANDARD
REMS; REMSSUPPL22AP2014-03-19N/A
LABELING; LabelingSUPPL23AP2014-01-30STANDARD
REMS; REMSSUPPL24AP2014-03-19N/A
LABELING; LabelingSUPPL25AP2014-03-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL26AP2014-03-19PRIORITY
REMS; REMSSUPPL27AP2016-02-12N/A
LABELING; LabelingSUPPL29AP2020-11-16STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15
SUPPL4Null7
SUPPL5Null6
SUPPL6Null6
SUPPL7Null6
SUPPL10Null7
SUPPL12Null15
SUPPL13Null6
SUPPL14Null6
SUPPL16Null15
SUPPL17Null6
SUPPL18Null6
SUPPL21Null6
SUPPL22Null6
SUPPL23Null6
SUPPL24Null7
SUPPL25Null7
SUPPL26Null0
SUPPL27Null15
SUPPL29Null15

CDER Filings

SANOFI AVENTIS US
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22425
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2014\/022425s025lbl.pdf#page=22"]
            [products] => [{"drugName":"MULTAQ","activeIngredients":"DRONEDARONE HYDROCHLORIDE","strength":"EQ 400MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/31\/2014","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022425s025lbl.pdf\"}]","notes":""},{"actionDate":"01\/30\/2014","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022425s023lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2013","submission":"SUPPL-21","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022425s021lbl.pdf\"}]","notes":""},{"actionDate":"09\/07\/2012","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022425s016s017s018lbl.pdf\"}]","notes":""},{"actionDate":"09\/07\/2012","submission":"SUPPL-17","supplementCategories":"REMS-Assessment","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022425s016s017s018lbl.pdf\"}]","notes":""},{"actionDate":"09\/07\/2012","submission":"SUPPL-17","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022425s016s017s018lbl.pdf\"}]","notes":""},{"actionDate":"09\/07\/2012","submission":"SUPPL-16","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022425s016s017s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/13\/2012","submission":"SUPPL-14","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022425s014lbl.pdf\"}]","notes":""},{"actionDate":"06\/13\/2012","submission":"SUPPL-14","supplementCategories":"REMS-Assessment","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022425s014lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2012","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022425s002lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2011","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022425s013lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2011","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022425s012lbl.pdf\"}]","notes":""},{"actionDate":"06\/21\/2011","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022425s010lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2011","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022425s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/11\/2011","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022425s001lbl.pdf\"}]","notes":""},{"actionDate":"01\/31\/2011","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022425s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/01\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022425lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MULTAQ","submission":"DRONEDARONE HYDROCHLORIDE","actionType":"EQ 400MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2014-03-31
        )

)
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