ASTRAZENECA FDA Approval NDA 018580

NDA 018580

ASTRAZENECA

FDA Drug Application

Application #018580

Application Sponsors

NDA 018580ASTRAZENECA

Marketing Status

Discontinued001
Discontinued002

Application Products

001INJECTABLE;INJECTION10MG/ML0YUTOPARRITODRINE HYDROCHLORIDE
002INJECTABLE;INJECTION15MG/ML0YUTOPARRITODRINE HYDROCHLORIDE

CDER Filings

ASTRAZENECA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18580
            [companyName] => ASTRAZENECA
            [docInserts] => ["",""]
            [products] => [{"drugName":"YUTOPAR","activeIngredients":"RITODRINE HYDROCHLORIDE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"YUTOPAR","activeIngredients":"RITODRINE HYDROCHLORIDE","strength":"15MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"YUTOPAR","submission":"RITODRINE HYDROCHLORIDE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"YUTOPAR","submission":"RITODRINE HYDROCHLORIDE","actionType":"15MG\/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.