NDA 019596

BAYER HLTHCARE

FDA Drug Application

Application #019596

Documents

• Letter: 2005-01-26
• Letter: 2006-09-15
• Letter: 2007-09-06
• Letter: 2010-12-22
• Letter: 2012-04-02
• Letter: 2013-10-18
• Letter: 2014-06-12
• Label: 2005-01-26
• Label: 2009-05-25
• Label: 2010-12-20
• Label: 2013-10-22
• Letter: 2010-08-31
• Letter: 2009-05-29
• Review: 2011-02-04
• Label: 2010-09-07
• Label: 2007-09-06
• Label: 2012-03-29
• Review: 2011-02-04
• Other Important Information from FDA: 2006-06-09
• Label: 2017-03-31
• Label: 2018-04-27
• Letter: 2018-06-20
• Label: 2018-07-26
• Label: 2018-07-26
• Letter: 2018-07-26
• Letter: 2018-07-26
• Medication Guide: 2018-07-27

Application Sponsors

NDA 019596

BAYER HLTHCARE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

469.01MG/ML

1

MAGNEVIST

GADOPENTETATE DIMEGLUMINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1988-06-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1989-03-23	PRIORITY
LABELING; Labeling	SUPPL	4	AP	1989-02-02
EFFICACY; Efficacy	SUPPL	5	AP	1989-08-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1992-02-12	PRIORITY
LABELING; Labeling	SUPPL	7	AP	1990-08-22
EFFICACY; Efficacy	SUPPL	8	AP	1993-08-17
EFFICACY; Efficacy	SUPPL	9	AP	1996-02-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1995-03-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1995-11-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1996-03-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1996-03-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1997-09-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1998-10-26	PRIORITY
LABELING; Labeling	SUPPL	18	AP	2000-03-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1999-02-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1999-11-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2000-10-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2000-11-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2001-04-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2001-11-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2002-10-29	PRIORITY
LABELING; Labeling	SUPPL	33	AP	2005-01-21	STANDARD
LABELING; Labeling	SUPPL	34	AP	2010-08-19	STANDARD
LABELING; Labeling	SUPPL	39	AP	2006-09-13	STANDARD
LABELING; Labeling	SUPPL	43	AP	2007-09-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	2009-05-22	N/A
LABELING; Labeling	SUPPL	49	AP	2010-12-20	901 REQUIRED
LABELING; Labeling	SUPPL	51	AP	2012-03-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	2012-11-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	2013-09-06	PRIORITY
LABELING; Labeling	SUPPL	56	AP	2013-10-17	STANDARD
LABELING; Labeling	SUPPL	57	AP	2014-06-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	58	AP	2015-12-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	59	AP	2016-11-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	2016-12-22	STANDARD
LABELING; Labeling	SUPPL	63	AP	2018-04-26	STANDARD
LABELING; Labeling	SUPPL	64	AP	2018-07-25	STANDARD
LABELING; Labeling	SUPPL	65	AP	2018-07-25	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	25	Null	0
SUPPL	27	Null	0
SUPPL	34	Null	6
SUPPL	49	Null	6
SUPPL	51	Null	6
SUPPL	54	Null	0
SUPPL	55	Null	0
SUPPL	56	Null	15
SUPPL	57	Null	15
SUPPL	58	Null	0
SUPPL	63	Null	7
SUPPL	64	Null	15
SUPPL	65	Null	6

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19596
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)