NDA 008032

GE HEALTHCARE

FDA Drug Application

Application #008032

Application Sponsors

NDA 008032

GE HEALTHCARE

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG

0

TELEPAQUE

IOPANOIC ACID

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1951-07-16	PRIORITY
LABELING; Labeling	SUPPL	9	AP	1976-10-18	PRIORITY
LABELING; Labeling	SUPPL	10	AP	1976-10-15	PRIORITY
LABELING; Labeling	SUPPL	11	AP	1976-10-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1976-10-15	PRIORITY
LABELING; Labeling	SUPPL	13	AP	1978-10-12	PRIORITY
LABELING; Labeling	SUPPL	15	AP	1979-11-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1983-09-30	PRIORITY
LABELING; Labeling	SUPPL	18	AP	1984-03-14	PRIORITY
LABELING; Labeling	SUPPL	19	AP	1985-04-19	PRIORITY
LABELING; Labeling	SUPPL	20	AP	1985-11-23	PRIORITY
LABELING; Labeling	SUPPL	21	AP	1986-07-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1987-05-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1990-05-02	PRIORITY

Submissions Property Types

ORIG	1	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 8032
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TELEPAQUE","activeIngredients":"IOPANOIC ACID","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TELEPAQUE","submission":"IOPANOIC ACID","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)