ANDA 214816

MSN

FDA Drug Application

Application #214816

Application Sponsors

ANDA 214816

MSN

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	2MG	0	TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE
002	TABLET;ORAL	4MG	0	TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE
003	TABLET;ORAL	12MG	0	TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE
004	TABLET;ORAL	16MG	0	TIAGABINE HYDROCHLORIDE	TIAGABINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-11-16

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

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
        )

)