ANDA 216013

HIKMA

FDA Drug Application

Application #216013

Application Sponsors

ANDA 216013

HIKMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

0.1MG

0

FLUDROCORTISONE ACETATE

FLUDROCORTISONE ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-10-27

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216013
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUDROCORTISONE ACETATE","activeIngredients":"FLUDROCORTISONE ACETATE","strength":"0.1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/27\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-27
        )

)