NDA 013731

GE HEALTHCARE

FDA Drug Application

Application #013731

Application Sponsors

NDA 013731

GE HEALTHCARE

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

750MG

0

BILOPAQUE

TYROPANOATE SODIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1969-10-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1976-05-11	STANDARD
LABELING; Labeling	SUPPL	12	AP	1977-06-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1977-06-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1978-10-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1978-12-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1979-05-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1982-02-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1979-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1980-01-25	STANDARD
LABELING; Labeling	SUPPL	20	AP	1982-06-30	STANDARD
LABELING; Labeling	SUPPL	21	AP	1984-02-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1984-07-11	STANDARD
LABELING; Labeling	SUPPL	24	AP	1984-11-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1986-07-11	STANDARD
LABELING; Labeling	SUPPL	26	AP	1986-07-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1987-05-20	STANDARD
LABELING; Labeling	SUPPL	28	AP	1988-02-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1990-02-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1995-02-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1991-02-21	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	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	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

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 13731
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"BILOPAQUE","activeIngredients":"TYROPANOATE SODIUM","strength":"750MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BILOPAQUE","submission":"TYROPANOATE SODIUM","actionType":"750MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)