NDA 018956

GE HEALTHCARE

FDA Drug Application

Application #018956

Documents

• Letter: 2002-12-23
• Letter: 2004-03-10
• Letter: 2004-12-29
• Letter: 2015-07-10
• Letter: 2002-12-23
• Letter: 2005-03-30
• Letter: 2007-10-04
• Review: 2003-08-05
• Label: 2015-07-09
• Review: 1998-05-11
• Label: 2017-04-07
• Letter: 2017-04-12
• Label: 2018-04-19
• Letter: 2018-04-20
• Label: 2020-07-06
• Letter: 2020-07-06
• Letter: 2020-11-05
• Label: 2021-01-25
• Label: 2021-08-06
• Letter: 2021-08-06
• Letter: 2022-02-22
• Label: 2022-02-25

Application Sponsors

NDA 018956

GE HEALTHCARE

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Discontinued: 006
• Discontinued: 007
• Prescription: 008
• Prescription: 009

Application Products

001	SOLUTION;INJECTION, ORAL, RECTAL	38.8%	1	OMNIPAQUE 180	IOHEXOL
002	SOLUTION;INJECTION, ORAL, RECTAL	51.8%	1	OMNIPAQUE 240	IOHEXOL
003	SOLUTION;INJECTION, ORAL, RECTAL	64.7%	1	OMNIPAQUE 300	IOHEXOL
004	SOLUTION;INJECTION, ORAL	75.5%	1	OMNIPAQUE 350	IOHEXOL
005	INJECTABLE;INJECTION	30.2%	1	OMNIPAQUE 140	IOHEXOL
006	INJECTABLE;INJECTION	45.3%	0	OMNIPAQUE 210	IOHEXOL
007	SOLUTION;URETHRAL	15.1%	0	OMNIPAQUE 70	IOHEXOL
008	SOLUTION;ORAL	1.9%	1	OMNIPAQUE 9	IOHEXOL
009	SOLUTION;ORAL	2.6%	1	OMNIPAQUE 12	IOHEXOL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1985-12-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1987-02-05	STANDARD
LABELING; Labeling	SUPPL	3	AP	1986-11-20
LABELING; Labeling	SUPPL	4	AP	1987-04-21
LABELING; Labeling	SUPPL	6	AP	1987-05-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1987-06-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1993-12-23	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	1987-05-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1989-05-22	STANDARD
EFFICACY; Efficacy	SUPPL	12	AP	1988-02-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1988-01-27	STANDARD
EFFICACY; Efficacy	SUPPL	14	AP	1988-07-29
EFFICACY; Efficacy	SUPPL	15	AP	1988-05-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1988-04-18	STANDARD
EFFICACY; Efficacy	SUPPL	17	AP	1988-11-30
EFFICACY; Efficacy	SUPPL	18	AP	1989-03-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1989-01-04	STANDARD
EFFICACY; Efficacy	SUPPL	20	AP	1989-06-30
EFFICACY; Efficacy	SUPPL	21	AP	1989-06-30
EFFICACY; Efficacy	SUPPL	22	AP	1989-07-28
EFFICACY; Efficacy	SUPPL	23	AP	1989-07-28
LABELING; Labeling	SUPPL	24	AP	1989-05-03
EFFICACY; Efficacy	SUPPL	26	AP	1989-11-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1992-03-26	STANDARD
EFFICACY; Efficacy	SUPPL	28	AP	1993-07-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1990-08-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1995-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1993-03-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1993-03-01	STANDARD
LABELING; Labeling	SUPPL	33	AP	1993-03-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1993-03-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1994-06-01	STANDARD
LABELING; Labeling	SUPPL	36	AP	1994-06-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1992-12-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1992-09-30	STANDARD
LABELING; Labeling	SUPPL	39	AP	2002-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1992-10-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1994-09-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1995-11-28	STANDARD
LABELING; Labeling	SUPPL	43	AP	1995-06-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1995-08-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1994-11-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1995-08-18	STANDARD
LABELING; Labeling	SUPPL	49	AP	2002-12-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1998-09-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	2000-12-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	2002-08-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	2002-11-20	STANDARD
LABELING; Labeling	SUPPL	58	AP	2004-03-05	STANDARD
LABELING; Labeling	SUPPL	62	AP	2004-12-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	65	AP	2005-03-25	STANDARD
LABELING; Labeling	SUPPL	76	AP	2007-10-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	89	AP	2013-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	91	AP	2014-02-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	92	AP	2013-11-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	93	AP	2014-06-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	94	AP	2015-03-03	STANDARD
LABELING; Labeling	SUPPL	95	AP	2015-07-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	96	AP	2015-10-21	STANDARD
LABELING; Labeling	SUPPL	99	AP	2017-04-05	STANDARD
LABELING; Labeling	SUPPL	101	AP	2018-04-17	STANDARD
LABELING; Labeling	SUPPL	105	AP	2020-07-02	STANDARD
LABELING; Labeling	SUPPL	108	AP	2020-11-04	STANDARD
LABELING; Labeling	SUPPL	112	AP	2021-08-05	STANDARD
LABELING; Labeling	SUPPL	113	AP	2022-02-18	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	0
SUPPL	16	Null	0
SUPPL	19	Null	0
SUPPL	27	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	51	Null	0
SUPPL	52	Null	0
SUPPL	53	Null	0
SUPPL	54	Null	0
SUPPL	65	Null	0
SUPPL	89	Null	0
SUPPL	91	Null	0
SUPPL	92	Null	0
SUPPL	93	Null	0
SUPPL	94	Null	0
SUPPL	95	Null	15
SUPPL	96	Null	0
SUPPL	99	Null	7
SUPPL	101	Null	7
SUPPL	105	Null	31
SUPPL	108	Null	6
SUPPL	112	Null	7
SUPPL	113	Null	7

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18956
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMNIPAQUE 12","activeIngredients":"IOHEXOL","strength":"2.6%","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"OMNIPAQUE 140","activeIngredients":"IOHEXOL","strength":"30.2%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"OMNIPAQUE 180","activeIngredients":"IOHEXOL","strength":"38.8%","dosageForm":"SOLUTION;INJECTION, ORAL, RECTAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"OMNIPAQUE 210","activeIngredients":"IOHEXOL","strength":"45.3%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OMNIPAQUE 240","activeIngredients":"IOHEXOL","strength":"51.8%","dosageForm":"SOLUTION;INJECTION, ORAL, RECTAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"OMNIPAQUE 300","activeIngredients":"IOHEXOL","strength":"64.7%","dosageForm":"SOLUTION;INJECTION, ORAL, RECTAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"OMNIPAQUE 350","activeIngredients":"IOHEXOL","strength":"75.5%","dosageForm":"SOLUTION;INJECTION, ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"OMNIPAQUE 70","activeIngredients":"IOHEXOL","strength":"15.1%","dosageForm":"SOLUTION;URETHRAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OMNIPAQUE 9","activeIngredients":"IOHEXOL","strength":"1.9%","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/02\/2020","submission":"SUPPL-105","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/018956s105lbl.pdf\"}]","notes":""},{"actionDate":"07\/02\/2020","submission":"SUPPL-105","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/018956s105lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2018","submission":"SUPPL-101","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/018956s101lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2018","submission":"SUPPL-101","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/018956s101lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2017","submission":"SUPPL-99","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/018956s099lbl.pdf\"}]","notes":""},{"actionDate":"07\/06\/2015","submission":"SUPPL-95","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 12","submission":"IOHEXOL","actionType":"2.6%","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"OMNIPAQUE 140","submission":"IOHEXOL","actionType":"30.2%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"OMNIPAQUE 180","submission":"IOHEXOL","actionType":"38.8%","submissionClassification":"SOLUTION;INJECTION, ORAL, RECTAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"OMNIPAQUE 210","submission":"IOHEXOL","actionType":"45.3%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OMNIPAQUE 240","submission":"IOHEXOL","actionType":"51.8%","submissionClassification":"SOLUTION;INJECTION, ORAL, RECTAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"OMNIPAQUE 300","submission":"IOHEXOL","actionType":"64.7%","submissionClassification":"SOLUTION;INJECTION, ORAL, RECTAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"OMNIPAQUE 350","submission":"IOHEXOL","actionType":"75.5%","submissionClassification":"SOLUTION;INJECTION, ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"OMNIPAQUE 70","submission":"IOHEXOL","actionType":"15.1%","submissionClassification":"SOLUTION;URETHRAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OMNIPAQUE 9","submission":"IOHEXOL","actionType":"1.9%","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-07-02
        )

)