GE HEALTHCARE FDA Approval NDA 017406

NDA 017406

GE HEALTHCARE

FDA Drug Application

Application #017406

Application Sponsors

NDA 017406GE HEALTHCARE

Marketing Status

Discontinued001

Application Products

001N/A;N/AN/A;N/A;N/A0DICOPAC KITCYANOCOBALAMIN; CYANOCOBALAMIN CO-57; CYANOCOBALAMIN CO-58

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP1974-06-10STANDARD
LABELING; LabelingSUPPL3AP1978-05-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1991-01-16STANDARD
LABELING; LabelingSUPPL7AP1994-08-05STANDARD

Submissions Property Types

ORIG1Null0
SUPPL3Null0
SUPPL6Null0
SUPPL7Null0

CDER Filings

GE HEALTHCARE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17406
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICOPAC KIT","activeIngredients":"CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; CYANOCOBALAMIN CO-58","strength":"N\/A;N\/A;N\/A","dosageForm":"N\/A;N\/A","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DICOPAC KIT","submission":"CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; CYANOCOBALAMIN CO-58","actionType":"N\/A;N\/A;N\/A","submissionClassification":"N\/A;N\/A","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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