ANDA 202705

AKORN

FDA Drug Application

Application #202705

Application Sponsors

ANDA 202705

AKORN

Marketing Status

• Prescription: 001

Application Products

001

OIL/DROPS;OTIC

0.01%

0

FLUOCINOLONE ACETONIDE

FLUOCINOLONE ACETONIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-09-09

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202705
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOCINOLONE ACETONIDE","activeIngredients":"FLUOCINOLONE ACETONIDE","strength":"0.01%","dosageForm":"OIL\/DROPS;OTIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/09\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-09-09
        )

)