GE HEALTHCARE FDA Approval NDA 018289

NDA 018289

GE HEALTHCARE

FDA Drug Application

Application #018289

Application Sponsors

NDA 018289GE HEALTHCARE

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION1mCi/ML0NEPHROFLOWIODOHIPPURATE SODIUM I-123

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1984-12-28STANDARD

CDER Filings

GE HEALTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18289
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEPHROFLOW","activeIngredients":"IODOHIPPURATE SODIUM I-123","strength":"1mCi\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NEPHROFLOW","submission":"IODOHIPPURATE SODIUM I-123","actionType":"1mCi\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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