ANDA 086505

GE HEALTHCARE

FDA Drug Application

Application #086505

Application Sponsors

ANDA 086505

GE HEALTHCARE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

66%;10%

0

HYPAQUE-76

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

FDA Submissions

	ORIG	1	AP	1980-07-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1982-05-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1982-05-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1982-11-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1987-01-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1987-01-29
LABELING; Labeling	SUPPL	14	AP	1989-05-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1991-01-23
LABELING; Labeling	SUPPL	16	AP	1991-10-11
LABELING; Labeling	SUPPL	17	AP	1995-06-16
LABELING; Labeling	SUPPL	18	AP	1996-06-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1998-11-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2001-08-29

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	15	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86505
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYPAQUE-76","activeIngredients":"DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM","strength":"66%;10%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYPAQUE-76","submission":"DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM","actionType":"66%;10%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)