ABBOTT FDA Approval NDA 019482

NDA 019482

ABBOTT

FDA Drug Application

Application #019482

Documents

Letter2002-02-04

Application Sponsors

NDA 019482ABBOTT

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION5GM/100ML;225MG/100ML0DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINERDEXTROSE; SODIUM CHLORIDE

FDA Submissions

MANUF (CMC); Manufacturing (CMC)SUPPL13AP2002-02-04STANDARD

Submissions Property Types

SUPPL13Null0

CDER Filings

ABBOTT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19482
            [companyName] => ABBOTT
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER","activeIngredients":"DEXTROSE; SODIUM CHLORIDE","strength":"5GM\/100ML;225MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER","submission":"DEXTROSE; SODIUM CHLORIDE","actionType":"5GM\/100ML;225MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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