ANDA 211146

ZYDUS PHARMS

FDA Drug Application

Application #211146

Documents

• Letter: 2021-10-08

Application Sponsors

ANDA 211146

ZYDUS PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	EQ 5MG BASE	0	VORTIOXETINE HYDROBROMIDE	VORTIOXETINE HYDROBROMIDE
002	TABLET;ORAL	EQ 10MG BASE	0	VORTIOXETINE HYDROBROMIDE	VORTIOXETINE HYDROBROMIDE
003	TABLET;ORAL	EQ 20MG BASE	0	VORTIOXETINE HYDROBROMIDE	VORTIOXETINE HYDROBROMIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-09-17

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

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
        )

)