NDA 018905

GUERBET

FDA Drug Application

Application #018905

Documents

• Letter: 2015-07-10
• Label: 2015-07-09
• Label: 2017-04-06
• Letter: 2017-04-12

Application Sponsors

NDA 018905

GUERBET

Marketing Status

• Discontinued: 002

Application Products

002

INJECTABLE;INJECTION

39.3%;19.6%

0

HEXABRIX

IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination	ORIG	1	AP	1985-07-26	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	1986-10-22
LABELING; Labeling	SUPPL	4	AP	1986-11-21
LABELING; Labeling	SUPPL	6	AP	1986-12-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1989-10-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1989-01-31	STANDARD
LABELING; Labeling	SUPPL	12	AP	1989-07-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1990-03-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1994-03-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1992-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1994-03-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1992-08-28	STANDARD
LABELING; Labeling	SUPPL	19	AP	1995-01-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1995-04-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1999-10-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2001-02-23	STANDARD
LABELING; Labeling	SUPPL	24	AP	2015-07-06	STANDARD
LABELING; Labeling	SUPPL	25	AP	2017-04-05	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	7
SUPPL	25	Null	15

CDER Filings

GUERBET

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18905
            [companyName] => GUERBET
            [docInserts] => ["",""]
            [products] => [{"drugName":"HEXABRIX","activeIngredients":"IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM","strength":"39.3%;19.6%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/05\/2017","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/018905s025lbl.pdf\"}]","notes":""},{"actionDate":"07\/06\/2015","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/018905s024lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"HEXABRIX","submission":"IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM","actionType":"39.3%;19.6%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2017-04-05
        )

)