ACTAVIS MID ATLANTIC FDA Approval ANDA 074536

ANDA 074536

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #074536

Application Sponsors

ANDA 074536ACTAVIS MID ATLANTIC

Marketing Status

Discontinued001

Application Products

001SOLUTION;ORALEQ 1MG BASE/ML0HALOPERIDOL LACTATEHALOPERIDOL LACTATE

FDA Submissions

ORIG1AP1995-11-02
LABELING; LabelingSUPPL2AP2017-02-23STANDARD

Submissions Property Types

SUPPL1Null7
SUPPL2Null7

CDER Filings

ACTAVIS MID ATLANTIC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74536
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HALOPERIDOL LACTATE","activeIngredients":"HALOPERIDOL LACTATE","strength":"EQ 1MG BASE\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HALOPERIDOL LACTATE","submission":"HALOPERIDOL LACTATE","actionType":"EQ 1MG BASE\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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