ANDA 205937

AKORN INC

FDA Drug Application

Application #205937

Application Sponsors

ANDA 205937

AKORN INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.5%

0

CYCLOPENTOLATE HYDROCHLORIDE

CYCLOPENTOLATE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-12-09

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AT

CDER Filings

AKORN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205937
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOPENTOLATE HYDROCHLORIDE","activeIngredients":"CYCLOPENTOLATE HYDROCHLORIDE","strength":"0.5%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/09\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-12-09
        )

)