NDA 016783

MALLINCKRODT

FDA Drug Application

Application #016783

Application Sponsors

NDA 016783

MALLINCKRODT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

52%;26%

0

VASCORAY

IOTHALAMATE MEGLUMINE; IOTHALAMATE SODIUM

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1971-01-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1975-07-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1976-01-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1976-01-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1976-05-10	STANDARD
LABELING; Labeling	SUPPL	12	AP	1976-05-14
LABELING; Labeling	SUPPL	13	AP	2009-03-13
EFFICACY; Efficacy	SUPPL	14	AP	1978-10-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1979-01-25	STANDARD
LABELING; Labeling	SUPPL	16	AP	2009-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1982-06-16	STANDARD
LABELING; Labeling	SUPPL	18	AP	1983-08-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1984-06-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1984-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1989-10-10	STANDARD
LABELING; Labeling	SUPPL	22	AP	1985-04-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1988-08-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1989-12-01	STANDARD
LABELING; Labeling	SUPPL	25	AP	1989-06-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1990-03-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1992-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1992-08-28	STANDARD
LABELING; Labeling	SUPPL	29	AP	1995-01-13	STANDARD

Submissions Property Types

SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16783
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"VASCORAY","activeIngredients":"IOTHALAMATE MEGLUMINE; IOTHALAMATE SODIUM","strength":"52%;26%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VASCORAY","submission":"IOTHALAMATE MEGLUMINE; IOTHALAMATE SODIUM","actionType":"52%;26%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)