ANDA 088059

AKORN

FDA Drug Application

Application #088059

Application Sponsors

ANDA 088059

AKORN

Marketing Status

• Discontinued: 001

Application Products

001

SUSPENSION/DROPS;OPHTHALMIC

0.5%;10%

0

PREDAMIDE

PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM

FDA Submissions

	ORIG	1	AP	1983-07-29
LABELING; Labeling	SUPPL	5	AP	1988-03-01
LABELING; Labeling	SUPPL	7	AP	1988-09-30
LABELING; Labeling	SUPPL	8	AP	1990-12-20

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88059
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREDAMIDE","activeIngredients":"PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM","strength":"0.5%;10%","dosageForm":"SUSPENSION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PREDAMIDE","submission":"PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM","actionType":"0.5%;10%","submissionClassification":"SUSPENSION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)