ANDA 086903

AKORN

FDA Drug Application

Application #086903

Application Sponsors

ANDA 086903

AKORN

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	40MG/ML	0	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE
002	INJECTABLE;INJECTION	80MG/ML	0	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86903
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLPREDNISOLONE ACETATE","activeIngredients":"METHYLPREDNISOLONE ACETATE","strength":"40MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"METHYLPREDNISOLONE ACETATE","activeIngredients":"METHYLPREDNISOLONE ACETATE","strength":"80MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHYLPREDNISOLONE ACETATE","submission":"METHYLPREDNISOLONE ACETATE","actionType":"40MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"METHYLPREDNISOLONE ACETATE","submission":"METHYLPREDNISOLONE ACETATE","actionType":"80MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)