ANDA 206686

ACTAVIS LABS FL INC

FDA Drug Application

Application #206686

Application Sponsors

ANDA 206686

ACTAVIS LABS FL INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

25MG

0

TETRABENAZINE

TETRABENAZINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-07-07

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206686
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TETRABENAZINE","activeIngredients":"TETRABENAZINE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/07\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/16\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-03-16
        )

)