ASTRAZENECA FDA Approval NDA 014394

NDA 014394

ASTRAZENECA

FDA Drug Application

Application #014394

Application Sponsors

NDA 014394ASTRAZENECA

Marketing Status

Discontinued001

Application Products

001AEROSOL;ORAL10%0XYLOCAINELIDOCAINE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1965-04-20STANDARD
LABELING; LabelingSUPPL2AP1985-01-04
LABELING; LabelingSUPPL9AP1994-03-28STANDARD

CDER Filings

ASTRAZENECA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 14394
            [companyName] => ASTRAZENECA
            [docInserts] => ["",""]
            [products] => [{"drugName":"XYLOCAINE","activeIngredients":"LIDOCAINE","strength":"10%","dosageForm":"AEROSOL;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"XYLOCAINE","submission":"LIDOCAINE","actionType":"10%","submissionClassification":"AEROSOL;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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