NDA 017506

GE HEALTHCARE

FDA Drug Application

Application #017506

Application Sponsors

NDA 017506

GE HEALTHCARE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

0.35MG/ML;140.1MG/ML;461.8MG/ML

0

ISOPAQUE 280

CALCIUM; MEGLUMINE; METRIZOIC ACID

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1974-04-30	STANDARD
LABELING; Labeling	SUPPL	2	AP	1976-06-04
LABELING; Labeling	SUPPL	3	AP	2007-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1978-02-01	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17506
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOPAQUE 280","activeIngredients":"CALCIUM; MEGLUMINE; METRIZOIC ACID","strength":"0.35MG\/ML;140.1MG\/ML;461.8MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOPAQUE 280","submission":"CALCIUM; MEGLUMINE; METRIZOIC ACID","actionType":"0.35MG\/ML;140.1MG\/ML;461.8MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)