NDA 021037

BAYER HLTHCARE

FDA Drug Application

Application #021037

Documents

• Letter: 2004-09-17
• Letter: 2010-08-31
• Letter: 2007-09-06
• Letter: 2010-12-22
• Letter: 2014-06-12
• Label: 2010-09-07
• Label: 2010-12-20
• Label: 2013-10-22
• Label: 2015-09-21
• Review: 2004-06-09
• Letter: 2006-09-15
• Letter: 2009-05-29
• Letter: 2012-04-02
• Letter: 2013-10-18
• Letter: 2015-08-03
• Label: 2007-09-06
• Label: 2009-05-25
• Label: 2012-03-29
• Label: 2014-06-17
• Other Important Information from FDA: 2011-12-21
• Label: 2018-04-27
• Letter: 2018-05-01
• Label: 2018-07-26
• Label: 2018-07-26
• Medication Guide: 2018-07-26
• Letter: 2018-07-26
• Letter: 2018-07-26

Application Sponsors

NDA 021037

BAYER HLTHCARE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

469.01MG/ML

1

MAGNEVIST

GADOPENTETATE DIMEGLUMINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2000-03-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-03-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2001-11-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-03-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2002-10-29	STANDARD
LABELING; Labeling	SUPPL	10	AP	2004-09-17	STANDARD
LABELING; Labeling	SUPPL	11	AP	2010-08-19	STANDARD
LABELING; Labeling	SUPPL	14	AP	2006-09-13	STANDARD
LABELING; Labeling	SUPPL	18	AP	2007-09-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2009-05-22	N/A
LABELING; Labeling	SUPPL	23	AP	2010-12-20	901 REQUIRED
LABELING; Labeling	SUPPL	25	AP	2012-03-29	STANDARD
LABELING; Labeling	SUPPL	29	AP	2013-10-17	STANDARD
LABELING; Labeling	SUPPL	30	AP	2014-06-11	STANDARD
LABELING; Labeling	SUPPL	31	AP	2015-07-31	STANDARD
LABELING; Labeling	SUPPL	36	AP	2018-04-26	STANDARD
LABELING; Labeling	SUPPL	37	AP	2018-07-25	STANDARD
LABELING; Labeling	SUPPL	38	AP	2018-07-25	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	11	Null	6
SUPPL	23	Null	7
SUPPL	25	Null	7
SUPPL	29	Null	15
SUPPL	30	Null	6
SUPPL	31	Null	6
SUPPL	36	Null	15
SUPPL	37	Null	6
SUPPL	38	Null	7

CDER Filings

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(
    [0] => Array
        (
            [ApplNo] => 21037
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)