ANDA 083358

AKORN

FDA Drug Application

Application #083358

Application Sponsors

ANDA 083358

AKORN

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	SOLUTION/DROPS;OPHTHALMIC	EQ 0.11% PHOSPHATE	0	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE
002	SOLUTION/DROPS;OPHTHALMIC	EQ 0.9% PHOSPHATE	0	PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE

FDA Submissions

	ORIG	1	AP	1974-08-21
LABELING; Labeling	SUPPL	7	AP	1989-06-19
LABELING; Labeling	SUPPL	8	AP	1990-12-31

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83358
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREDNISOLONE SODIUM PHOSPHATE","activeIngredients":"PREDNISOLONE SODIUM PHOSPHATE","strength":"EQ 0.11% PHOSPHATE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PREDNISOLONE SODIUM PHOSPHATE","activeIngredients":"PREDNISOLONE SODIUM PHOSPHATE","strength":"EQ 0.9% PHOSPHATE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PREDNISOLONE SODIUM PHOSPHATE","submission":"PREDNISOLONE SODIUM PHOSPHATE","actionType":"EQ 0.11% PHOSPHATE","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PREDNISOLONE SODIUM PHOSPHATE","submission":"PREDNISOLONE SODIUM PHOSPHATE","actionType":"EQ 0.9% PHOSPHATE","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)