ABBOTT FDA Approval NDA 019784

NDA 019784

ABBOTT

FDA Drug Application

Application #019784

Application Sponsors

NDA 019784ABBOTT

Marketing Status

Discontinued001

Application Products

001SUSPENSION;ORAL100MG/5ML0IBUIBUPROFEN

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1989-12-12STANDARD

CDER Filings

ABBOTT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19784
            [companyName] => ABBOTT
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBU","activeIngredients":"IBUPROFEN","strength":"100MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBU","submission":"IBUPROFEN","actionType":"100MG\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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