ANDA 208212

TEVA PHARMS USA

FDA Drug Application

Application #208212

Application Sponsors

ANDA 208212

TEVA PHARMS USA

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	10MG	0	VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE
002	TABLET;ORAL	20MG	0	VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE
003	TABLET;ORAL	40MG	0	VILAZODONE HYDROCHLORIDE	VILAZODONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-09-30

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

TEVA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208212
            [companyName] => TEVA PHARMS USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"VILAZODONE HYDROCHLORIDE","activeIngredients":"VILAZODONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VILAZODONE HYDROCHLORIDE","activeIngredients":"VILAZODONE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"VILAZODONE HYDROCHLORIDE","activeIngredients":"VILAZODONE HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/30\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-09-30
        )

)