MIKART FDA Approval ANDA 081067

ANDA 081067

MIKART

FDA Drug Application

Application #081067

Application Sponsors

ANDA 081067MIKART

Marketing Status

Discontinued001

Application Products

001CAPSULE;ORAL500MG;5MG0HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

ORIG1AP1989-11-30
LABELING; LabelingSUPPL2AP1996-03-13
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1995-02-08
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1995-03-27
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1995-08-11
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1998-07-31
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2002-08-13

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0

CDER Filings

MIKART
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 81067
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"500MG;5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"500MG;5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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