ASTRAZENECA FDA Approval NDA 019082

NDA 019082

ASTRAZENECA

FDA Drug Application

Application #019082

Application Sponsors

NDA 019082ASTRAZENECA

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001INJECTABLE;INJECTION5MG/ML0DALGANDEZOCINE
002INJECTABLE;INJECTION10MG/ML0DALGANDEZOCINE
003INJECTABLE;INJECTION15MG/ML0DALGANDEZOCINE

CDER Filings

ASTRAZENECA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19082
            [companyName] => ASTRAZENECA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DALGAN","activeIngredients":"DEZOCINE","strength":"5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DALGAN","activeIngredients":"DEZOCINE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DALGAN","activeIngredients":"DEZOCINE","strength":"15MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DALGAN","submission":"DEZOCINE","actionType":"5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DALGAN","submission":"DEZOCINE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DALGAN","submission":"DEZOCINE","actionType":"15MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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