ABBOTT FDA Approval ANDA 085667

ANDA 085667

ABBOTT

FDA Drug Application

Application #085667

Application Sponsors

ANDA 085667ABBOTT

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL500MG;5MG0VICODINACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

MANUF (CMC); Manufacturing (CMC)SUPPL20AP1984-05-25

Submissions Property Types

SUPPL20Null0

CDER Filings

ABBOTT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85667
            [companyName] => ABBOTT
            [docInserts] => ["",""]
            [products] => [{"drugName":"VICODIN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"500MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VICODIN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"500MG;5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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