ANDA 210554

AMNEAL PHARMS LLC

FDA Drug Application

Application #210554

Application Sponsors

ANDA 210554

AMNEAL PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.05%

0

FLUOCINONIDE

FLUOCINONIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-08-21

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB1

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210554
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOCINONIDE","activeIngredients":"FLUOCINONIDE","strength":"0.05%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/21\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-08-21
        )

)