ZYDUS PHARMS FDA Approval ANDA 211146

ANDA 211146

ZYDUS PHARMS

FDA Drug Application

Application #211146

Documents

Letter2021-10-08

Application Sponsors

ANDA 211146ZYDUS PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORALEQ 5MG BASE0VORTIOXETINE HYDROBROMIDEVORTIOXETINE HYDROBROMIDE
002TABLET;ORALEQ 10MG BASE0VORTIOXETINE HYDROBROMIDEVORTIOXETINE HYDROBROMIDE
003TABLET;ORALEQ 20MG BASE0VORTIOXETINE HYDROBROMIDEVORTIOXETINE HYDROBROMIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-09-17STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ZYDUS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211146
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VORTIOXETINE HYDROBROMIDE","activeIngredients":"VORTIOXETINE HYDROBROMIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VORTIOXETINE HYDROBROMIDE","activeIngredients":"VORTIOXETINE HYDROBROMIDE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VORTIOXETINE HYDROBROMIDE","activeIngredients":"VORTIOXETINE HYDROBROMIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/17\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-17
        )

)

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