MIKART FDA Approval ANDA 081226

ANDA 081226

MIKART

FDA Drug Application

Application #081226

Application Sponsors

ANDA 081226MIKART

Marketing Status

Discontinued001

Application Products

001SOLUTION;ORAL500MG/15ML;5MG/15ML0HYDROCODONE BITARTRATE AND ACETAMINOPHENACETAMINOPHEN; HYDROCODONE BITARTRATE

FDA Submissions

ORIG1AP1992-10-27
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1996-01-18
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1998-07-31
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2002-08-13

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL4Null0
SUPPL5Null0

CDER Filings

MIKART
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 81226
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"500MG\/15ML;5MG\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"500MG\/15ML;5MG\/15ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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