ANDA 209739

HIKMA

FDA Drug Application

Application #209739

Application Sponsors

ANDA 209739

HIKMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	12.5MG	0	TETRABENAZINE	TETRABENAZINE
002	TABLET;ORAL	25MG	0	TETRABENAZINE	TETRABENAZINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-04-08

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209739
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TETRABENAZINE","activeIngredients":"TETRABENAZINE","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TETRABENAZINE","activeIngredients":"TETRABENAZINE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/08\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-08
        )

)