ALLERGAN FDA Approval NDA 022567

NDA 022567

ALLERGAN

FDA Drug Application

Application #022567

Documents

Letter2011-01-26
Letter2011-09-23
Letter2011-07-06
Letter2013-12-19
Letter2015-04-02
Letter2014-07-17
Label2011-09-23
Label2013-01-11
Label2013-12-19
Label2014-04-08
Label2015-03-19
Label2014-07-17
Review2011-03-01
Other Important Information from FDA2012-02-13
Summary Review2011-03-01
Letter2012-12-26
Letter2014-04-09
Label2011-01-24
Label2016-09-06
Letter2016-09-08
Label2017-01-06
Medication Guide2017-01-11
Letter2017-01-11
Label2020-02-03
Medication Guide2020-02-03
Letter2020-02-04
Pediatric Written Request1900-01-01
Pediatric Amendment 11900-01-01
Pediatric Medical Review1900-01-01
Letter2021-09-22
Label2021-09-24
Medication Guide2021-09-24

Application Sponsors

NDA 022567ALLERGAN

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL10MG1VIIBRYDVILAZODONE HYDROCHLORIDE
002TABLET;ORAL20MG1VIIBRYDVILAZODONE HYDROCHLORIDE
003TABLET;ORAL40MG1VIIBRYDVILAZODONE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2011-01-21STANDARD
REMS; REMSSUPPL2AP2011-06-29N/A
LABELING; LabelingSUPPL5AP2012-12-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2012-12-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2013-01-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2013-06-08STANDARD
LABELING; LabelingSUPPL9AP2013-12-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2014-04-17STANDARD
LABELING; LabelingSUPPL11AP2014-04-07STANDARD
EFFICACY; EfficacySUPPL12AP2015-03-16STANDARD
LABELING; LabelingSUPPL13AP2014-07-16901 REQUIRED
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2015-06-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2015-12-16STANDARD
LABELING; LabelingSUPPL19AP2016-09-06901 REQUIRED
LABELING; LabelingSUPPL20AP2017-01-04901 REQUIRED
EFFICACY; EfficacySUPPL21AP2020-01-31PRIORITY
LABELING; LabelingSUPPL22AP2021-09-20901 REQUIRED

Submissions Property Types

ORIG1Null7
SUPPL2Null7
SUPPL5Null6
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null15
SUPPL10Null0
SUPPL11Null6
SUPPL12Null7
SUPPL13Null7
SUPPL15Null0
SUPPL16Null0
SUPPL19Null7
SUPPL20Null7
SUPPL21Null7
SUPPL22Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ALLERGAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22567
            [companyName] => ALLERGAN
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/022567s021lbl.pdf#page=17"]
            [products] => [{"drugName":"VIIBRYD","activeIngredients":"VILAZODONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"VIIBRYD","activeIngredients":"VILAZODONE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"VIIBRYD","activeIngredients":"VILAZODONE HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"01\/31\/2020","submission":"SUPPL-21","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022567s021lbl.pdf\"}]","notes":""},{"actionDate":"01\/04\/2017","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022567s020lbl.pdf\"}]","notes":""},{"actionDate":"09\/06\/2016","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022567s019lbl.pdf\"}]","notes":""},{"actionDate":"03\/16\/2015","submission":"SUPPL-12","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022567s012lbl.pdf\"}]","notes":""},{"actionDate":"07\/16\/2014","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022567s013lbl.pdf\"}]","notes":""},{"actionDate":"04\/07\/2014","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022567s011lbl.pdf\"}]","notes":""},{"actionDate":"12\/17\/2013","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022567s009lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2012","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022567s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/21\/2011","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022567s001lbl.pdf\"}]","notes":""},{"actionDate":"01\/21\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022567s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"VIIBRYD","submission":"VILAZODONE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"VIIBRYD","submission":"VILAZODONE HYDROCHLORIDE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"VIIBRYD","submission":"VILAZODONE HYDROCHLORIDE","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-01-31
        )

)
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