INVAGEN PHARMS FDA Approval ANDA 208200

ANDA 208200

INVAGEN PHARMS

FDA Drug Application

Application #208200

Application Sponsors

ANDA 208200INVAGEN PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL10MG0VILAZODONE HYDROCHLORIDEVILAZODONE HYDROCHLORIDE
002TABLET;ORAL40MG0VILAZODONE HYDROCHLORIDEVILAZODONE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-04-07STANDARD
UNKNOWN; ORIG2TA2021-04-07STANDARD

Submissions Property Types

ORIG1Null7
ORIG2Null31

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

INVAGEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208200
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VILAZODONE HYDROCHLORIDE","activeIngredients":"VILAZODONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VILAZODONE HYDROCHLORIDE","activeIngredients":"VILAZODONE HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/07\/2021","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/07\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-07
        )

)

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