NDA 014295

MALLINCKRODT

FDA Drug Application

Application #014295

Application Sponsors

NDA 014295

MALLINCKRODT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

66.8%

0

CONRAY 400

IOTHALAMATE SODIUM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1963-09-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1975-07-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1976-01-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1976-01-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1976-05-05	STANDARD
LABELING; Labeling	SUPPL	21	AP	1976-05-05
LABELING; Labeling	SUPPL	22	AP	1978-05-30
EFFICACY; Efficacy	SUPPL	23	AP	1978-12-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1978-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1981-08-27	STANDARD
LABELING; Labeling	SUPPL	28	AP	1982-05-10
LABELING; Labeling	SUPPL	29	AP	1983-04-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1984-06-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1984-12-04	STANDARD
LABELING; Labeling	SUPPL	32	AP	1984-06-19
LABELING; Labeling	SUPPL	33	AP	1984-09-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1989-10-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1988-08-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1989-12-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1992-08-28	STANDARD
LABELING; Labeling	SUPPL	38	AP	1989-07-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1990-03-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1992-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1992-08-28	STANDARD
LABELING; Labeling	SUPPL	42	AP	1995-01-13	STANDARD

Submissions Property Types

SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	24	Null	0
SUPPL	27	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 14295
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"CONRAY 400","activeIngredients":"IOTHALAMATE SODIUM","strength":"66.8%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CONRAY 400","submission":"IOTHALAMATE SODIUM","actionType":"66.8%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)