ASTRAZENECA FDA Approval ANDA 072018

ANDA 072018

ASTRAZENECA

FDA Drug Application

Application #072018

Application Sponsors

ANDA 072018ASTRAZENECA

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION2.5MG/ML0DROPERIDOLDROPERIDOL

FDA Submissions

ORIG1AP1988-10-20
LABELING; LabelingSUPPL2AP1995-05-08
LABELING; LabelingSUPPL3AP1995-12-22

CDER Filings

ASTRAZENECA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72018
            [companyName] => ASTRAZENECA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DROPERIDOL","activeIngredients":"DROPERIDOL","strength":"2.5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DROPERIDOL","submission":"DROPERIDOL","actionType":"2.5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.