MALLINCKRODT FDA Approval ANDA 087075

ANDA 087075

MALLINCKRODT

FDA Drug Application

Application #087075

Application Sponsors

ANDA 087075MALLINCKRODT

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION50%0MD-50DIATRIZOATE SODIUM

FDA Submissions

MANUF (CMC); Manufacturing (CMC)SUPPL4AP1984-11-15
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1987-02-04

Submissions Property Types

SUPPL4Null0
SUPPL5Null0

CDER Filings

MALLINCKRODT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87075
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"MD-50","activeIngredients":"DIATRIZOATE SODIUM","strength":"50%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MD-50","submission":"DIATRIZOATE SODIUM","actionType":"50%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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