ACTAVIS LABS FL INC FDA Approval ANDA 212472

ANDA 212472

ACTAVIS LABS FL INC

FDA Drug Application

Application #212472

Application Sponsors

ANDA 212472ACTAVIS LABS FL INC

Marketing Status

Prescription001

Application Products

001TABLET, EXTENDED RELEASE;ORAL20MG;20MG0DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDEDOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-03-01STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

ACTAVIS LABS FL INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212472
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE","activeIngredients":"DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE","strength":"20MG;20MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/01\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-01
        )

)

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