ACTAVIS LABS FL INC FDA Approval ANDA 206686

ANDA 206686

ACTAVIS LABS FL INC

FDA Drug Application

Application #206686

Application Sponsors

ANDA 206686ACTAVIS LABS FL INC

Marketing Status

Prescription001

Application Products

001TABLET;ORAL25MG0TETRABENAZINETETRABENAZINE

FDA Submissions

UNKNOWN; ORIG1AP2017-07-07STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

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
        )

)

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