ANDA 091302

HIKMA PHARMS

FDA Drug Application

Application #091302

Application Sponsors

ANDA 091302

HIKMA PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

0.1MG

0

FLUDROCORTISONE ACETATE

FLUDROCORTISONE ACETATE

FDA Submissions

ORIG

1

AP

2011-07-22

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91302
            [companyName] => HIKMA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUDROCORTISONE ACETATE","activeIngredients":"FLUDROCORTISONE ACETATE","strength":"0.1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUDROCORTISONE ACETATE","submission":"FLUDROCORTISONE ACETATE","actionType":"0.1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)