ANDA 204055

AKORN

FDA Drug Application

Application #204055

Application Sponsors

ANDA 204055

AKORN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.05%

0

EPINASTINE HYDROCHLORIDE

EPINASTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-05-05

Submissions Property Types

ORIG

1

Null

17

TE Codes

001

Prescription

AT

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204055
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPINASTINE HYDROCHLORIDE","activeIngredients":"EPINASTINE HYDROCHLORIDE","strength":"0.05%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/05\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-05-05
        )

)