MALLINCKRODT FDA Approval NDA 017551

NDA 017551

MALLINCKRODT

FDA Drug Application

Application #017551

Application Sponsors

NDA 017551MALLINCKRODT

Marketing Status

Discontinued001

Application Products

001CAPSULE;ORAL200MG0PERCHLORACAPPOTASSIUM PERCHLORATE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1974-11-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1977-07-27STANDARD
LABELING; LabelingSUPPL3AP1983-07-26STANDARD
LABELING; LabelingSUPPL4AP1990-01-19
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1994-06-30STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL5Null0

CDER Filings

MALLINCKRODT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17551
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"PERCHLORACAP","activeIngredients":"POTASSIUM PERCHLORATE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PERCHLORACAP","submission":"POTASSIUM PERCHLORATE","actionType":"200MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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