ABBOTT FDA Approval NDA 019565

NDA 019565

ABBOTT

FDA Drug Application

Application #019565

Application Sponsors

NDA 019565ABBOTT

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION5%;25GM/100ML0AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINERAMINO ACIDS; DEXTROSE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP1986-12-17STANDARD
LABELING; LabelingSUPPL3AP1987-06-27

CDER Filings

ABBOTT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19565
            [companyName] => ABBOTT
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER","activeIngredients":"AMINO ACIDS; DEXTROSE","strength":"5%;25GM\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER","submission":"AMINO ACIDS; DEXTROSE","actionType":"5%;25GM\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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