ANDA 084492

AKORN

FDA Drug Application

Application #084492

Application Sponsors

ANDA 084492

AKORN

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

PREDNISOLONE ACETATE

PREDNISOLONE ACETATE

FDA Submissions

ORIG

1

AP

1975-06-12

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
        )

)