AKORN FDA Approval ANDA 084492

ANDA 084492

AKORN

FDA Drug Application

Application #084492

Application Sponsors

ANDA 084492AKORN

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION50MG/ML0PREDNISOLONE ACETATEPREDNISOLONE ACETATE

FDA Submissions

ORIG1AP1975-06-12

CDER Filings

AKORN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84492
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREDNISOLONE ACETATE","activeIngredients":"PREDNISOLONE ACETATE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PREDNISOLONE ACETATE","submission":"PREDNISOLONE ACETATE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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