ORGANON USA INC FDA Approval NDA 011228

NDA 011228

ORGANON USA INC

FDA Drug Application

Application #011228

Application Sponsors

NDA 011228ORGANON USA INC

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL3MG0LIQUAMARPHENPROCOUMON

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP1957-12-30STANDARD
LABELING; LabelingSUPPL6AP1978-11-29
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1978-11-29STANDARD
LABELING; LabelingSUPPL8AP1992-09-01

Submissions Property Types

SUPPL7Null0

CDER Filings

ORGANON USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 11228
            [companyName] => ORGANON USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIQUAMAR","activeIngredients":"PHENPROCOUMON","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LIQUAMAR","submission":"PHENPROCOUMON","actionType":"3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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