ANDA 209913

ENCUBE ETHICALS

FDA Drug Application

Application #209913

Application Sponsors

ANDA 209913

ENCUBE ETHICALS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;TOPICAL

0.01%

0

FLUOCINOLONE ACETONIDE

FLUOCINOLONE ACETONIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-02-13

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT

CDER Filings

ENCUBE ETHICALS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209913
            [companyName] => ENCUBE ETHICALS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOCINOLONE ACETONIDE","activeIngredients":"FLUOCINOLONE ACETONIDE","strength":"0.01%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/13\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-13
        )

)