NDA 016847

GE HEALTHCARE

FDA Drug Application

Application #016847

Application Sponsors

NDA 016847

GE HEALTHCARE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

0.78MG/ML;75.9MG/ML;0.15MG/ML;16.6MG/ML

0

ISOPAQUE 440

CALCIUM METRIZOATE; MEGLUMINE METRIZOATE; METRIZOATE MAGNESIUM; METRIZOATE SODIUM

FDA Submissions

TYPE 2/4; Type 2 New Active Ingredient and Type 4 New Combination	ORIG	1	AP	1973-11-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1976-03-26	STANDARD
LABELING; Labeling	SUPPL	3	AP	1975-11-21
LABELING; Labeling	SUPPL	4	AP	1977-09-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1977-08-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1977-09-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1978-02-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1979-02-15	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16847
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOPAQUE 440","activeIngredients":"CALCIUM METRIZOATE; MEGLUMINE METRIZOATE; METRIZOATE MAGNESIUM; METRIZOATE SODIUM","strength":"0.78MG\/ML;75.9MG\/ML;0.15MG\/ML;16.6MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOPAQUE 440","submission":"CALCIUM METRIZOATE; MEGLUMINE METRIZOATE; METRIZOATE MAGNESIUM; METRIZOATE SODIUM","actionType":"0.78MG\/ML;75.9MG\/ML;0.15MG\/ML;16.6MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)