PLIVA FDA Approval ANDA 072124

ANDA 072124

PLIVA

FDA Drug Application

Application #072124

Application Sponsors

ANDA 072124PLIVA

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL80MG0VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE

FDA Submissions

ORIG1AP1989-01-26
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1992-02-10
LABELING; LabelingSUPPL3AP1992-04-06
LABELING; LabelingSUPPL4AP1992-09-08
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1994-05-11
LABELING; LabelingSUPPL7AP1998-08-05
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2000-07-07

Submissions Property Types

SUPPL2Null0
SUPPL5Null0
SUPPL8Null0

CDER Filings

PLIVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72124
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"VERAPAMIL HYDROCHLORIDE","activeIngredients":"VERAPAMIL HYDROCHLORIDE","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VERAPAMIL HYDROCHLORIDE","submission":"VERAPAMIL HYDROCHLORIDE","actionType":"80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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