ANDA 088465

HIKMA PHARMS

FDA Drug Application

Application #088465

Application Sponsors

ANDA 088465

HIKMA PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

50MG

0

PREDNISONE

PREDNISONE

FDA Submissions

	ORIG	1	AP	1984-06-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1991-12-16
LABELING; Labeling	SUPPL	4	AP	1994-02-09
LABELING; Labeling	SUPPL	5	AP	1994-11-14

Submissions Property Types

SUPPL

3

Null

0

TE Codes

001

Prescription

AB

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88465
            [companyName] => HIKMA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREDNISONE","activeIngredients":"PREDNISONE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PREDNISONE","submission":"PREDNISONE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)