IMPAX LABS FDA Approval ANDA 080782

ANDA 080782

IMPAX LABS

FDA Drug Application

Application #080782

Application Sponsors

ANDA 080782IMPAX LABS

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL5MG0PREDNISONEPREDNISONE

CDER Filings

IMPAX LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80782
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREDNISONE","activeIngredients":"PREDNISONE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PREDNISONE","submission":"PREDNISONE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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