ANDA 091514

AKORN

FDA Drug Application

Application #091514

Documents

• Letter: 2015-06-29

Application Sponsors

ANDA 091514

AKORN

Marketing Status

• Prescription: 001

Application Products

001

OIL;TOPICAL

0.01%

0

FLUOCINOLONE ACETONIDE

FLUOCINOLONE ACETONIDE

FDA Submissions

ORIG

1

AP

2015-06-25

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91514
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOCINOLONE ACETONIDE","activeIngredients":"FLUOCINOLONE ACETONIDE","strength":"0.01%","dosageForm":"OIL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUOCINOLONE ACETONIDE","submission":"FLUOCINOLONE ACETONIDE","actionType":"0.01%","submissionClassification":"OIL;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)