ANDA 085555

AKORN

FDA Drug Application

Application #085555

Application Sponsors

ANDA 085555

AKORN

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

1%

0

AK-PENTOLATE

CYCLOPENTOLATE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1979-04-10
LABELING; Labeling	SUPPL	3	AP	1989-04-25
LABELING; Labeling	SUPPL	4	AP	1991-02-13
LABELING; Labeling	SUPPL	5	AP	1991-03-18

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85555
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"AK-PENTOLATE","activeIngredients":"CYCLOPENTOLATE HYDROCHLORIDE","strength":"1%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AK-PENTOLATE","submission":"CYCLOPENTOLATE HYDROCHLORIDE","actionType":"1%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)