ALLERGAN FDA Approval NDA 204370

NDA 204370

ALLERGAN

FDA Drug Application

Application #204370

Documents

Letter2015-09-18
Review2015-10-28
Label2015-09-18
Label2017-02-24
Letter2017-03-02
Label2017-11-14
Label2017-11-14
Letter2017-11-15
Letter2017-11-15
Letter2018-12-19
Label2019-05-24
Medication Guide2019-05-29
Letter2019-06-04
Label2022-12-19
Medication Guide2022-12-19
Letter2022-12-20

Application Sponsors

NDA 204370ALLERGAN

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001CAPSULE;ORALEQ 1.5MG BASE1VRAYLARCARIPRAZINE HYDROCHLORIDE
002CAPSULE;ORALEQ 3MG BASE1VRAYLARCARIPRAZINE HYDROCHLORIDE
003CAPSULE;ORALEQ 4.5MG BASE1VRAYLARCARIPRAZINE HYDROCHLORIDE
004CAPSULE;ORALEQ 6MG BASE1VRAYLARCARIPRAZINE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2015-09-17STANDARD
EFFICACY; EfficacyORIG2AP2015-09-17STANDARD
LABELING; LabelingSUPPL3AP2017-11-09STANDARD
LABELING; LabelingSUPPL5AP2018-11-28STANDARD
EFFICACY; EfficacySUPPL6AP2019-05-24STANDARD
EFFICACY; EfficacySUPPL9AP2022-12-16STANDARD

Submissions Property Types

ORIG1Null40
ORIG2Null6
SUPPL3Null7
SUPPL5Null7
SUPPL6Null31
SUPPL9Null6

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

ALLERGAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204370
            [companyName] => ALLERGAN
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/204370s006lbl.pdf#page=39"]
            [products] => [{"drugName":"VRAYLAR","activeIngredients":"CARIPRAZINE HYDROCHLORIDE","strength":"EQ 1.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"VRAYLAR","activeIngredients":"CARIPRAZINE HYDROCHLORIDE","strength":"EQ 3MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"VRAYLAR","activeIngredients":"CARIPRAZINE HYDROCHLORIDE","strength":"EQ 4.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"VRAYLAR","activeIngredients":"CARIPRAZINE HYDROCHLORIDE","strength":"EQ 6MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/24\/2019","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204370s006lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204370s002s003lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2017","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204370s002s003lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204370s001lbl.pdf\"}]","notes":""},{"actionDate":"09\/17\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204370lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/17\/2015","submission":"ORIG-2","actionType":"Approval","submissionClassification":"Efficacy","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/17\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204370lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204370Orig1Orig2s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/204370Orig2s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/24\/2019","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204370s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/204370Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"11\/28\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204370Orig1s005ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"11\/09\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204370s002s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/0204370Orig1s002s003ltr.pdf\"}]","notes":">"},{"actionDate":"11\/09\/2017","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204370s002s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/0204370Orig1s002s003ltr.pdf\"}]","notes":">"},{"actionDate":"02\/23\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204370s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204370Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-05-24
        )

)
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