ROCHE FDA Approval NDA 010423

NDA 010423

ROCHE

FDA Drug Application

Application #010423

Application Sponsors

NDA 010423ROCHE

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION1MG/ML0LORFANLEVALLORPHAN TARTRATE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1956-04-30STANDARD
LABELING; LabelingSUPPL7AP2001-09-17
LABELING; LabelingSUPPL8AP1983-05-11
LABELING; LabelingSUPPL9AP1983-04-19

CDER Filings

ROCHE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 10423
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORFAN","activeIngredients":"LEVALLORPHAN TARTRATE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LORFAN","submission":"LEVALLORPHAN TARTRATE","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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