ANDA 085418

HIKMA PHARMS

FDA Drug Application

Application #085418

Application Sponsors

ANDA 085418

HIKMA PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

15MG

0

SODIUM BUTABARBITAL

BUTABARBITAL SODIUM

FDA Submissions

	ORIG	1	AP	1977-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1982-11-08
LABELING; Labeling	SUPPL	7	AP	1988-03-16
LABELING; Labeling	SUPPL	8	AP	1989-08-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1991-03-28

Submissions Property Types

SUPPL	4	Null	0
SUPPL	9	Null	0

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85418
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM BUTABARBITAL","activeIngredients":"BUTABARBITAL SODIUM","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SODIUM BUTABARBITAL","submission":"BUTABARBITAL SODIUM","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)