GE HEALTHCARE FDA Approval NDA 018335

NDA 018335

GE HEALTHCARE

FDA Drug Application

Application #018335

Application Sponsors

NDA 018335GE HEALTHCARE

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTIONN/A0AMERSCAN MDP KITTECHNETIUM TC-99M MEDRONATE KIT

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP1982-08-05STANDARD
LABELING; LabelingSUPPL2AP1988-08-24STANDARD

Submissions Property Types

ORIG1Null0
SUPPL2Null0

CDER Filings

GE HEALTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18335
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMERSCAN MDP KIT","activeIngredients":"TECHNETIUM TC-99M MEDRONATE KIT","strength":"N\/A","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMERSCAN MDP KIT","submission":"TECHNETIUM TC-99M MEDRONATE KIT","actionType":"N\/A","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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