PAR PHARM FDA Approval ANDA 089208

ANDA 089208

PAR PHARM

FDA Drug Application

Application #089208

Application Sponsors

ANDA 089208PAR PHARM

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL24MG0METHYLPREDNISOLONEMETHYLPREDNISOLONE

FDA Submissions

ORIG1AP1988-04-25
LABELING; LabelingSUPPL2AP1995-03-09
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1996-06-07

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0

CDER Filings

PAR PHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89208
            [companyName] => PAR PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLPREDNISOLONE","activeIngredients":"METHYLPREDNISOLONE","strength":"24MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHYLPREDNISOLONE","submission":"METHYLPREDNISOLONE","actionType":"24MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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