MSN FDA Approval ANDA 214816

ANDA 214816

MSN

FDA Drug Application

Application #214816

Application Sponsors

ANDA 214816MSN

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL2MG0TIAGABINE HYDROCHLORIDETIAGABINE HYDROCHLORIDE
002TABLET;ORAL4MG0TIAGABINE HYDROCHLORIDETIAGABINE HYDROCHLORIDE
003TABLET;ORAL12MG0TIAGABINE HYDROCHLORIDETIAGABINE HYDROCHLORIDE
004TABLET;ORAL16MG0TIAGABINE HYDROCHLORIDETIAGABINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-11-16STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

MSN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214816
            [companyName] => MSN
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIAGABINE HYDROCHLORIDE","activeIngredients":"TIAGABINE HYDROCHLORIDE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TIAGABINE HYDROCHLORIDE","activeIngredients":"TIAGABINE HYDROCHLORIDE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TIAGABINE HYDROCHLORIDE","activeIngredients":"TIAGABINE HYDROCHLORIDE","strength":"12MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TIAGABINE HYDROCHLORIDE","activeIngredients":"TIAGABINE HYDROCHLORIDE","strength":"16MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/16\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-16
        )

)

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