ABBOTT FDA Approval NDA 018804

NDA 018804

ABBOTT

FDA Drug Application

Application #018804

Application Sponsors

NDA 018804ABBOTT

Marketing Status

Discontinued001
Discontinued002

Application Products

001INJECTABLE;INJECTION3.5% (3.5GM/100ML)0AMINOSYN 3.5% IN PLASTIC CONTAINERAMINO ACIDS
002INJECTABLE;INJECTION3.5%;21MG/100ML;40MG/100ML;128MG/100ML;234MG/100ML0AMINOSYN 3.5% M IN PLASTIC CONTAINERAMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE

CDER Filings

ABBOTT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18804
            [companyName] => ABBOTT
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMINOSYN 3.5% IN PLASTIC CONTAINER","activeIngredients":"AMINO ACIDS","strength":"3.5% (3.5GM\/100ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMINOSYN 3.5% M IN PLASTIC CONTAINER","activeIngredients":"AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE","strength":"3.5%;21MG\/100ML;40MG\/100ML;128MG\/100ML;234MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMINOSYN 3.5% IN PLASTIC CONTAINER","submission":"AMINO ACIDS","actionType":"3.5% (3.5GM\/100ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMINOSYN 3.5% M IN PLASTIC CONTAINER","submission":"AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE","actionType":"3.5%;21MG\/100ML;40MG\/100ML;128MG\/100ML;234MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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