ANDA 212443

ENCUBE

FDA Drug Application

Application #212443

Application Sponsors

ANDA 212443

ENCUBE

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

2%

0

KETOCONAZOLE

KETOCONAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-05-20

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

ENCUBE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212443
            [companyName] => ENCUBE
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOCONAZOLE","activeIngredients":"KETOCONAZOLE","strength":"2%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/20\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-20
        )

)