ABBOTT FDA Approval NDA 018203

NDA 018203

ABBOTT

FDA Drug Application

Application #018203

Application Sponsors

NDA 018203ABBOTT

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION10% (10GM/100ML)0LIPOSYN 10%SAFFLOWER OIL

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1979-05-16STANDARD
LABELING; LabelingSUPPL2AP1979-07-03
LABELING; LabelingSUPPL8AP1980-05-19
LABELING; LabelingSUPPL9AP1980-05-06
LABELING; LabelingSUPPL14AP1981-12-17
LABELING; LabelingSUPPL15AP1981-04-14
LABELING; LabelingSUPPL16AP1981-07-21
LABELING; LabelingSUPPL18AP1982-01-11
LABELING; LabelingSUPPL19AP1981-08-17
LABELING; LabelingSUPPL20AP1982-02-22
LABELING; LabelingSUPPL23AP1982-03-01
LABELING; LabelingSUPPL24AP1982-03-08
LABELING; LabelingSUPPL26AP1982-06-21
LABELING; LabelingSUPPL27AP1996-04-26
LABELING; LabelingSUPPL29AP1984-02-24

CDER Filings

ABBOTT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18203
            [companyName] => ABBOTT
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIPOSYN 10%","activeIngredients":"SAFFLOWER OIL","strength":"10% (10GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LIPOSYN 10%","submission":"SAFFLOWER OIL","actionType":"10% (10GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.