PLIVA FDA Approval ANDA 071667

ANDA 071667

PLIVA

FDA Drug Application

Application #071667

Application Sponsors

ANDA 071667PLIVA

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL600MG0IBUPROFENIBUPROFEN

FDA Submissions

ORIG1AP1987-06-18
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1988-01-11
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1988-01-11
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1988-07-05
LABELING; LabelingSUPPL7AP1989-02-01
BIOEQUIV; BioequivalenceSUPPL12AP1989-12-07
LABELING; LabelingSUPPL13AP1992-01-31
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1994-05-11
LABELING; LabelingSUPPL17AP2016-05-09STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL5Null0
SUPPL12Null0
SUPPL14Null0
SUPPL17Null15

CDER Filings

PLIVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71667
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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