PLIVA FDA Approval ANDA 072751

ANDA 072751

PLIVA

FDA Drug Application

Application #072751

Application Sponsors

ANDA 072751PLIVA

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL40MG0VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE

FDA Submissions

ORIG1AP1996-02-23
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2000-07-07

Submissions Property Types

SUPPL2Null0

CDER Filings

PLIVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72751
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"VERAPAMIL HYDROCHLORIDE","activeIngredients":"VERAPAMIL HYDROCHLORIDE","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VERAPAMIL HYDROCHLORIDE","submission":"VERAPAMIL HYDROCHLORIDE","actionType":"40MG","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.