ANDA 203660

AKORN

FDA Drug Application

Application #203660

Application Sponsors

ANDA 203660

AKORN

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.05%

0

AZELASTINE HYDROCHLORIDE

AZELASTINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-11-08

Submissions Property Types

ORIG

1

Null

17

TE Codes

001

Prescription

AT

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203660
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZELASTINE HYDROCHLORIDE","activeIngredients":"AZELASTINE HYDROCHLORIDE","strength":"0.05%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/08\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-11-08
        )

)