NDA 020608

GE HEALTHCARE

FDA Drug Application

Application #020608

Documents

• Letter: 2007-10-04
• Label: 2015-07-09
• Letter: 2004-03-10
• Letter: 2004-03-03
• Letter: 2015-07-10
• Label: 2016-12-21
• Letter: 2016-12-23
• Label: 2017-04-07
• Label: 2017-04-07
• Letter: 2017-04-12
• Letter: 2017-11-13
• Label: 2017-11-14
• Letter: 2022-02-22
• Label: 2022-02-25

Application Sponsors

NDA 020608

GE HEALTHCARE

Marketing Status

• Discontinued: 001
• Prescription: 002
• Prescription: 003

Application Products

001	SOLUTION;INJECTION, ORAL, RECTAL	51.8%	0	OMNIPAQUE 240	IOHEXOL
002	SOLUTION;INJECTION, ORAL, RECTAL	64.7%	0	OMNIPAQUE 300	IOHEXOL
003	SOLUTION;INJECTION, ORAL	75.5%	0	OMNIPAQUE 350	IOHEXOL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1995-10-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1997-06-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-12-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-08-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-11-20	STANDARD
LABELING; Labeling	SUPPL	9	AP	2004-03-05	STANDARD
LABELING; Labeling	SUPPL	10	AP	2004-02-13	STANDARD
LABELING; Labeling	SUPPL	18	AP	2007-10-01	STANDARD
LABELING; Labeling	SUPPL	31	AP	2015-07-06	STANDARD
LABELING; Labeling	SUPPL	34	AP	2016-12-21	STANDARD
LABELING; Labeling	SUPPL	36	AP	2017-04-05	STANDARD
LABELING; Labeling	SUPPL	37	AP	2017-04-05	STANDARD
LABELING; Labeling	SUPPL	38	AP	2017-11-09	STANDARD
LABELING; Labeling	SUPPL	45	AP	2022-02-18	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	31	Null	6
SUPPL	34	Null	6
SUPPL	36	Null	15
SUPPL	37	Null	6
SUPPL	38	Null	6
SUPPL	45	Null	7

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20608
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMNIPAQUE 240","activeIngredients":"IOHEXOL","strength":"51.8%","dosageForm":"SOLUTION;INJECTION, ORAL, RECTAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OMNIPAQUE 300","activeIngredients":"IOHEXOL","strength":"64.7%","dosageForm":"SOLUTION;INJECTION, ORAL, RECTAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"OMNIPAQUE 350","activeIngredients":"IOHEXOL","strength":"75.5%","dosageForm":"SOLUTION;INJECTION, ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/09\/2017","submission":"SUPPL-38","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020608s038lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2017","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020608s038lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2017","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020608s037lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2017","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020608s036lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2016","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020608s034lbl.pdf\"}]","notes":""},{"actionDate":"07\/06\/2015","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/018956s095,020608s031lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"OMNIPAQUE 240","submission":"IOHEXOL","actionType":"51.8%","submissionClassification":"SOLUTION;INJECTION, ORAL, RECTAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OMNIPAQUE 300","submission":"IOHEXOL","actionType":"64.7%","submissionClassification":"SOLUTION;INJECTION, ORAL, RECTAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OMNIPAQUE 350","submission":"IOHEXOL","actionType":"75.5%","submissionClassification":"SOLUTION;INJECTION, ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2017-11-09
        )

)