NDA 018385

NOVO NORDISK INC

FDA Drug Application

Application #018385

Application Sponsors

NDA 018385

NOVO NORDISK INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

100 UNITS/ML

0

ULTRALENTE

INSULIN ZINC SUSP EXTENDED PURIFIED BEEF

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1980-03-17	STANDARD
LABELING; Labeling	SUPPL	7	AP	1985-05-08
LABELING; Labeling	SUPPL	9	AP	1986-09-17

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
        )

)