NDA 011386

GE HEALTHCARE

FDA Drug Application

Application #011386

Application Sponsors

NDA 011386

GE HEALTHCARE

Marketing Status

• Discontinued: 001
• Discontinued: 003

Application Products

001	FOR SOLUTION;ORAL, RECTAL	100%	0	HYPAQUE	DIATRIZOATE SODIUM
003	SOLUTION;ORAL, RECTAL	40%	0	HYPAQUE	DIATRIZOATE SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1956-03-26	STANDARD
LABELING; Labeling	SUPPL	11	AP	1976-09-29
LABELING; Labeling	SUPPL	13	AP	1977-12-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1979-07-05	STANDARD
LABELING; Labeling	SUPPL	15	AP	1984-01-12
LABELING; Labeling	SUPPL	16	AP	1982-06-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1991-05-29	STANDARD
LABELING; Labeling	SUPPL	21	AP	1984-09-12
LABELING; Labeling	SUPPL	22	AP	1984-12-28
LABELING; Labeling	SUPPL	23	AP	1986-02-10
LABELING; Labeling	SUPPL	24	AP	1986-03-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1986-08-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1988-08-02	STANDARD
LABELING; Labeling	SUPPL	27	AP	1988-05-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1990-08-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1990-08-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1993-10-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1996-08-23	STANDARD
LABELING; Labeling	SUPPL	33	AP	1995-06-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1994-09-30	STANDARD

Submissions Property Types

SUPPL	14	Null	0
SUPPL	19	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	34	Null	0

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 11386
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYPAQUE","activeIngredients":"DIATRIZOATE SODIUM","strength":"100%","dosageForm":"FOR SOLUTION;ORAL, RECTAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYPAQUE","activeIngredients":"DIATRIZOATE SODIUM","strength":"40%","dosageForm":"SOLUTION;ORAL, RECTAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYPAQUE","submission":"DIATRIZOATE SODIUM","actionType":"100%","submissionClassification":"FOR SOLUTION;ORAL, RECTAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYPAQUE","submission":"DIATRIZOATE SODIUM","actionType":"40%","submissionClassification":"SOLUTION;ORAL, RECTAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)