NDA 010220

GE HEALTHCARE

FDA Drug Application

Application #010220

Application Sponsors

NDA 010220

GE HEALTHCARE

Marketing Status

• Discontinued: 002
• Discontinued: 003

Application Products

002	INJECTABLE;INJECTION	60%;30%	0	HYPAQUE-M,90%	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
003	INJECTABLE;INJECTION	50%;25%	0	HYPAQUE-M,75%	DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1955-11-09	STANDARD
LABELING; Labeling	SUPPL	17	AP	1974-01-29	STANDARD
S; Supplement	SUPPL	21	AP	1976-01-21	STANDARD
LABELING; Labeling	SUPPL	22	AP	1976-01-21	STANDARD
LABELING; Labeling	SUPPL	23	AP	1976-01-26	STANDARD
LABELING; Labeling	SUPPL	24	AP	1976-04-08	STANDARD
LABELING; Labeling	SUPPL	25	AP	1978-03-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1978-02-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1978-02-01	STANDARD
LABELING; Labeling	SUPPL	28	AP	1978-03-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1979-02-17	STANDARD
LABELING; Labeling	SUPPL	30	AP	1984-08-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1983-02-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1983-11-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1988-05-23	STANDARD
LABELING; Labeling	SUPPL	34	AP	1984-09-13	STANDARD
LABELING; Labeling	SUPPL	35	AP	1985-06-26	STANDARD
LABELING; Labeling	SUPPL	36	AP	1985-07-24	STANDARD
LABELING; Labeling	SUPPL	37	AP	1986-06-25	STANDARD
LABELING; Labeling	SUPPL	38	AP	1986-06-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1990-02-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1989-04-11	STANDARD
LABELING; Labeling	SUPPL	41	AP	1989-05-19	STANDARD
LABELING; Labeling	SUPPL	42	AP	1989-06-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1991-04-24	STANDARD
LABELING; Labeling	SUPPL	44	AP	1991-10-03	STANDARD
LABELING; Labeling	SUPPL	45	AP	1990-09-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1994-03-25	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	17	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 10220
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYPAQUE-M,75%","activeIngredients":"DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM","strength":"50%;25%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYPAQUE-M,90%","activeIngredients":"DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM","strength":"60%;30%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYPAQUE-M,75%","submission":"DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM","actionType":"50%;25%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYPAQUE-M,90%","submission":"DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM","actionType":"60%;30%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)