IMPAX LABS FDA Approval ANDA 080785

ANDA 080785

IMPAX LABS

FDA Drug Application

Application #080785

Application Sponsors

ANDA 080785IMPAX LABS

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL50MG0TRIPELENNAMINE HYDROCHLORIDETRIPELENNAMINE HYDROCHLORIDE

CDER Filings

IMPAX LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80785
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIPELENNAMINE HYDROCHLORIDE","activeIngredients":"TRIPELENNAMINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRIPELENNAMINE HYDROCHLORIDE","submission":"TRIPELENNAMINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;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.