NDA 020351

GE HEALTHCARE

FDA Drug Application

Application #020351

Documents

• Letter: 2004-06-30
• Letter: 2003-12-23
• Letter: 2015-07-10
• Letter: 2003-09-25
• Letter: 2004-03-28
• Letter: 2005-01-11
• Letter: 2005-04-28
• Letter: 2005-08-31
• Label: 2003-12-29
• Label: 2015-07-09
• Label: 2017-04-07
• Label: 2017-04-07
• Letter: 2017-04-12
• Letter: 2017-04-12
• Pediatric CDTL Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Label: 2019-03-13
• Letter: 2019-03-14
• Review: 2019-06-03
• Letter: 2020-05-11
• Letter: 2020-07-06
• Label: 2020-07-06
• Letter: 2022-02-22
• Label: 2022-02-24

Application Sponsors

NDA 020351

GE HEALTHCARE

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	55%	1	VISIPAQUE 270	IODIXANOL
002	INJECTABLE;INJECTION	65.2%	1	VISIPAQUE 320	IODIXANOL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1996-03-22	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	1997-10-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-09-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-10-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-11-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-06-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-05-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-12-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2003-09-04	STANDARD
LABELING; Labeling	SUPPL	13	AP	2003-12-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2004-03-24	STANDARD
LABELING; Labeling	SUPPL	18	AP	2004-12-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2005-04-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2005-08-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2007-03-05	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	2013-09-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2013-11-20	STANDARD
LABELING; Labeling	SUPPL	43	AP	2015-07-06	STANDARD
EFFICACY; Efficacy	SUPPL	44	AP	2017-04-05	PRIORITY
LABELING; Labeling	SUPPL	45	AP	2017-04-05	STANDARD
LABELING; Labeling	SUPPL	48	AP	2019-03-12	STANDARD
LABELING; Labeling	SUPPL	50	AP	2020-07-02	STANDARD
LABELING; Labeling	SUPPL	52	TA	2019-11-08	STANDARD
LABELING; Labeling	SUPPL	54	AP	2022-02-18	STANDARD

Submissions Property Types

SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	16	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	43	Null	7
SUPPL	44	Null	15
SUPPL	45	Null	6
SUPPL	48	Null	7
SUPPL	50	Null	7
SUPPL	52	Null	15
SUPPL	54	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20351
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"VISIPAQUE 270","activeIngredients":"IODIXANOL","strength":"55%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"VISIPAQUE 320","activeIngredients":"IODIXANOL","strength":"65.2%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/02\/2020","submission":"SUPPL-50","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020351s050lbl.pdf\"}]","notes":""},{"actionDate":"07\/02\/2020","submission":"SUPPL-50","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020351s050lbl.pdf\"}]","notes":""},{"actionDate":"03\/12\/2019","submission":"SUPPL-48","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020351s048,020808s028lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2017","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020351s045lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2017","submission":"SUPPL-44","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020351s044lbl.pdf\"}]","notes":""},{"actionDate":"07\/06\/2015","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020351s043,020808s024lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2003","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20351slr013_visipaque_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"VISIPAQUE 270","submission":"IODIXANOL","actionType":"55%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"VISIPAQUE 320","submission":"IODIXANOL","actionType":"65.2%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-07-02
        )

)