ANDA 084855

AKORN

FDA Drug Application

Application #084855

Application Sponsors

ANDA 084855

AKORN

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OTIC

EQ 0.1% PHOSPHATE

0

DEXAMETHASONE SODIUM PHOSPHATE

DEXAMETHASONE SODIUM PHOSPHATE

FDA Submissions

	ORIG	1	AP	1976-06-29
LABELING; Labeling	SUPPL	10	AP	1990-04-11
LABELING; Labeling	SUPPL	11	AP	1992-02-05

Submissions Property Types

SUPPL

10

Null

1

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84855
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXAMETHASONE SODIUM PHOSPHATE","activeIngredients":"DEXAMETHASONE SODIUM PHOSPHATE","strength":"EQ 0.1% PHOSPHATE","dosageForm":"SOLUTION\/DROPS;OTIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXAMETHASONE SODIUM PHOSPHATE","submission":"DEXAMETHASONE SODIUM PHOSPHATE","actionType":"EQ 0.1% PHOSPHATE","submissionClassification":"SOLUTION\/DROPS;OTIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)