NOVO NORDISK INC FDA Approval NDA 018385

NDA 018385

NOVO NORDISK INC

FDA Drug Application

Application #018385

Application Sponsors

NDA 018385NOVO NORDISK INC

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION100 UNITS/ML0ULTRALENTEINSULIN ZINC SUSP EXTENDED PURIFIED BEEF

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1980-03-17STANDARD
LABELING; LabelingSUPPL7AP1985-05-08
LABELING; LabelingSUPPL9AP1986-09-17

CDER Filings

NOVO NORDISK INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18385
            [companyName] => NOVO NORDISK INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ULTRALENTE","activeIngredients":"INSULIN ZINC SUSP EXTENDED PURIFIED BEEF","strength":"100 UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ULTRALENTE","submission":"INSULIN ZINC SUSP EXTENDED PURIFIED BEEF","actionType":"100 UNITS\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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