ABBOTT FDA Approval NDA 018614

NDA 018614

ABBOTT

FDA Drug Application

Application #018614

Application Sponsors

NDA 018614ABBOTT

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION20% (20GM/100ML)0LIPOSYN 20%SAFFLOWER OIL

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1981-10-26STANDARD
LABELING; LabelingSUPPL2AP1982-04-20
LABELING; LabelingSUPPL3AP1982-03-08
LABELING; LabelingSUPPL6AP1982-10-22
LABELING; LabelingSUPPL7AP1996-04-26
LABELING; LabelingSUPPL9AP1984-02-27
LABELING; LabelingSUPPL11AP1984-08-10

CDER Filings

ABBOTT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18614
            [companyName] => ABBOTT
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIPOSYN 20%","activeIngredients":"SAFFLOWER OIL","strength":"20% (20GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LIPOSYN 20%","submission":"SAFFLOWER OIL","actionType":"20% (20GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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