MIKART FDA Approval ANDA 081095

ANDA 081095

MIKART

FDA Drug Application

Application #081095

Application Sponsors

ANDA 081095MIKART

Marketing Status

Discontinued001

Application Products

001CAPSULE;ORAL150MG;180MG;15MG0ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATEACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE

FDA Submissions

ORIG1AP1990-10-26
LABELING; LabelingSUPPL2AP1991-12-09
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1991-12-09
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1998-07-31

Submissions Property Types

SUPPL1Null0
SUPPL3Null0
SUPPL4Null0

CDER Filings

MIKART
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 81095
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE","strength":"150MG;180MG;15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE","actionType":"150MG;180MG;15MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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