NDA 017685

MALLINCKRODT

FDA Drug Application

Application #017685

Application Sponsors

NDA 017685

MALLINCKRODT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

54.3%

0

CONRAY 325

IOTHALAMATE SODIUM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1976-09-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1978-09-06	STANDARD
LABELING; Labeling	SUPPL	3	AP	2009-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1981-08-24	STANDARD
LABELING; Labeling	SUPPL	5	AP	2009-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1984-06-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1984-12-04	STANDARD
LABELING; Labeling	SUPPL	8	AP	1985-03-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1989-10-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1989-12-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1992-08-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1990-03-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1992-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1992-08-28	STANDARD
LABELING; Labeling	SUPPL	15	AP	1995-01-13	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17685
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"CONRAY 325","activeIngredients":"IOTHALAMATE SODIUM","strength":"54.3%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CONRAY 325","submission":"IOTHALAMATE SODIUM","actionType":"54.3%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)