NDA 020123

GE HEALTHCARE

FDA Drug Application

Application #020123

Documents

• Letter: 2002-07-08
• Letter: 2010-12-22
• Letter: 2013-08-29
• Letter: 2014-11-18
• Label: 2007-12-27
• Label: 2010-12-20
• Label: 2013-08-28
• Review: 1997-10-03
• Letter: 2002-05-17
• Letter: 2002-06-28
• Letter: 2003-07-31
• Letter: 2007-09-07
• Letter: 2008-01-09
• Other Important Information from FDA: 2006-06-09
• Label: 2007-09-06
• Label: 2014-11-20
• Label: 2018-04-27
• Medication Guide: 2018-04-27
• Letter: 2018-05-01
• Label: 2018-11-06
• Letter: 2018-11-08

Application Sponsors

NDA 020123

GE HEALTHCARE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

287MG/ML

1

OMNISCAN

GADODIAMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1993-01-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-11-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1994-06-06	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	1996-02-05	UNKNOWN
EFFICACY; Efficacy	SUPPL	5	AP	1996-02-05	STANDARD
EFFICACY; Efficacy	SUPPL	7	AP	1996-02-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1995-02-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1997-03-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1997-03-19	STANDARD
LABELING; Labeling	SUPPL	15	AP	1997-10-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2001-01-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-03-13	STANDARD
LABELING; Labeling	SUPPL	18	AP	2002-07-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2001-07-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2002-03-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2002-05-20	STANDARD
LABELING; Labeling	SUPPL	22	AP	2002-06-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2002-11-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2002-08-12	STANDARD
LABELING; Labeling	SUPPL	34	AP	2007-09-05	STANDARD
LABELING; Labeling	SUPPL	35	AP	2007-12-14	STANDARD
LABELING; Labeling	SUPPL	37	AP	2010-12-20	UNKNOWN
LABELING; Labeling	SUPPL	39	AP	2013-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	2014-05-14	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2014-04-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	2014-06-23	STANDARD
LABELING; Labeling	SUPPL	43	AP	2014-11-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	2016-06-06	STANDARD
LABELING; Labeling	SUPPL	46	AP	2018-04-26	STANDARD
LABELING; Labeling	SUPPL	47	AP	2018-11-07	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	9	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	37	Null	6
SUPPL	39	Null	15
SUPPL	40	Null	15
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	15
SUPPL	44	Null	0
SUPPL	46	Null	7
SUPPL	47	Null	15

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20123
            [companyName] => GE HEALTHCARE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/020123s046lbl.pdf#page=1"]
            [products] => [{"drugName":"OMNISCAN","activeIngredients":"GADODIAMIDE","strength":"287MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/07\/2018","submission":"SUPPL-47","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020123s047,022066s009lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2018","submission":"SUPPL-46","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020123s046lbl.pdf\"}]","notes":""},{"actionDate":"11\/14\/2014","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022066s007,020123s043lbl.pdf\"}]","notes":""},{"actionDate":"08\/27\/2013","submission":"SUPPL-39","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022066s00420123s039lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2010","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020123s037lbl.pdf\"}]","notes":""},{"actionDate":"12\/14\/2007","submission":"SUPPL-35","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020123s035lbl.pdf\"}]","notes":""},{"actionDate":"09\/05\/2007","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020123s034lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"OMNISCAN","submission":"GADODIAMIDE","actionType":"287MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-11-07
        )

)