ANDA 040667

HIKMA INTL PHARMS

FDA Drug Application

Application #040667

Application Sponsors

ANDA 040667

HIKMA INTL PHARMS

Marketing Status

• Discontinued: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	50MG	0	PRIMIDONE	PRIMIDONE
002	TABLET;ORAL	250MG	0	PRIMIDONE	PRIMIDONE

FDA Submissions

	ORIG	1	AP	2006-07-27
LABELING; Labeling	SUPPL	2	AP	2010-05-20
LABELING; Labeling	SUPPL	4	AP	2011-11-29

Submissions Property Types

SUPPL	2	Null	7
SUPPL	4	Null	15

TE Codes

002

Prescription

AB

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40667
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PRIMIDONE","activeIngredients":"PRIMIDONE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PRIMIDONE","activeIngredients":"PRIMIDONE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PRIMIDONE","submission":"PRIMIDONE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PRIMIDONE","submission":"PRIMIDONE","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)