PLIVA FDA Approval ANDA 074647

ANDA 074647

PLIVA

FDA Drug Application

Application #074647

Application Sponsors

ANDA 074647PLIVA

Marketing Status

Discontinued001
Discontinued002

Application Products

001TABLET;ORAL50MG0FLURBIPROFENFLURBIPROFEN
002TABLET;ORAL100MG0FLURBIPROFENFLURBIPROFEN

FDA Submissions

ORIG1AP1997-04-01

Submissions Property Types

SUPPL1Null0

CDER Filings

PLIVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74647
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLURBIPROFEN","activeIngredients":"FLURBIPROFEN","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FLURBIPROFEN","activeIngredients":"FLURBIPROFEN","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLURBIPROFEN","submission":"FLURBIPROFEN","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FLURBIPROFEN","submission":"FLURBIPROFEN","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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