ANDA 208948

ZYDUS PHARMS

FDA Drug Application

Application #208948

Application Sponsors

ANDA 208948

ZYDUS PHARMS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;TOPICAL

0.05%

0

FLUOCINONIDE

FLUOCINONIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-07-17

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AT

CDER Filings

ZYDUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208948
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOCINONIDE","activeIngredients":"FLUOCINONIDE","strength":"0.05%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/17\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-17
        )

)