PLIVA FDA Approval ANDA 072126

ANDA 072126

PLIVA

FDA Drug Application

Application #072126

Application Sponsors

ANDA 072126PLIVA

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL125MG0METHYLDOPAMETHYLDOPA

FDA Submissions

ORIG1AP1988-07-07
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1989-06-26
LABELING; LabelingSUPPL3AP1990-10-30
LABELING; LabelingSUPPL4AP1992-04-22
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1993-05-05
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1993-05-05
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1993-05-05
LABELING; LabelingSUPPL8AP1993-05-05
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1994-05-11
LABELING; LabelingSUPPL10AP1996-06-10
LABELING; LabelingSUPPL11AP1998-06-12

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0

CDER Filings

PLIVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72126
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLDOPA","activeIngredients":"METHYLDOPA","strength":"125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHYLDOPA","submission":"METHYLDOPA","actionType":"125MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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