BAYER HLTHCARE FDA Approval NDA 021277

Application #021277

Documents

Letter	2001-11-30
Letter	2002-05-16
Letter	2003-03-10
Letter	2004-05-26
Letter	2004-03-10
Letter	2004-07-30
Letter	2005-11-30
Letter	2008-12-31
Letter	2008-10-07
Letter	2009-06-29
Letter	2010-11-02
Letter	2011-10-20
Label	2001-11-30
Label	2002-06-12
Label	2003-02-28
Label	2004-05-27
Label	2004-04-05
Label	2005-06-14
Label	2005-11-30
Label	2009-01-02
Label	2009-05-15
Label	2009-12-02
Label	2010-03-05
Label	2011-03-04
Label	2011-10-20
Label	2012-09-11
Label	2014-12-03
Label	2015-06-05
Label	2016-07-26
Review	2004-05-27
Review	2008-02-19
Letter	2002-05-22
Letter	2002-06-12
Letter	2003-03-10
Letter	2003-03-10
Letter	2003-10-06
Letter	2005-06-14
Letter	2005-11-30
Letter	2007-06-04
Letter	2008-02-20
Letter	2009-05-05
Letter	2010-01-25
Letter	2010-04-09
Letter	2011-03-02
Letter	2011-08-08
Letter	2011-10-20
Letter	2012-08-28
Letter	2012-12-26
Letter	2013-08-16
Letter	2014-11-24
Letter	2015-05-13
Letter	2016-07-26
Label	2002-05-16
Label	2003-02-28
Label	2003-02-28
Label	2003-10-10
Label	2004-07-30
Label	2005-11-30
Label	2007-06-04
Label	2008-02-25
Label	2008-10-09
Label	2010-10-25
Label	2011-10-20
Label	2012-12-21
Label	2013-08-15
Review	2008-02-19
Letter	2016-09-30
Label	2016-09-30
Letter	2016-09-30
Label	2017-03-09
Label	2018-10-19
Letter	2018-10-23
Letter	2019-05-06
Medication Guide	2019-05-08
Label	2019-05-08
Letter	2020-05-07
Label	2020-05-07
Medication Guide	2020-05-07

Application Sponsors

NDA 021277

BAYER HLTHCARE

Marketing Status

Discontinued

001

Application Products

001

SOLUTION;INTRAVENOUS

400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

MOXIFLOXACIN HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2001-11-30	STANDARD
LABELING; Labeling	SUPPL	2	AP	2002-06-12	STANDARD
LABELING; Labeling	SUPPL	3	AP	2002-05-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-12-10	STANDARD
LABELING; Labeling	SUPPL	6	AP	2003-02-28	STANDARD
EFFICACY; Efficacy	SUPPL	7	AP	2003-02-28	STANDARD
LABELING; Labeling	SUPPL	9	AP	2003-02-28	STANDARD
LABELING; Labeling	SUPPL	11	AP	2003-10-06	STANDARD
EFFICACY; Efficacy	SUPPL	17	AP	2004-05-18	PRIORITY
LABELING; Labeling	SUPPL	18	AP	2004-03-06	STANDARD
LABELING; Labeling	SUPPL	19	AP	2004-07-28	STANDARD
EFFICACY; Efficacy	SUPPL	22	AP	2005-06-13	STANDARD
EFFICACY; Efficacy	SUPPL	24	AP	2005-11-22	UNKNOWN
LABELING; Labeling	SUPPL	25	AP	2005-11-22	STANDARD
LABELING; Labeling	SUPPL	30	AP	2007-05-31	STANDARD
LABELING; Labeling	SUPPL	31	AP	2008-02-15	STANDARD
LABELING; Labeling	SUPPL	33	AP	2008-12-29	STANDARD
LABELING; Labeling	SUPPL	34	AP	2008-10-03	STANDARD
LABELING; Labeling	SUPPL	35	AP	2009-06-24	STANDARD
LABELING; Labeling	SUPPL	36	AP	2009-04-27	STANDARD
LABELING; Labeling	SUPPL	38	AP	2010-10-25	STANDARD
LABELING; Labeling	SUPPL	39	AP	2009-11-24	UNKNOWN
LABELING; Labeling	SUPPL	40	AP	2010-03-02	UNKNOWN
LABELING; Labeling	SUPPL	41	AP	2011-02-25	901 REQUIRED
LABELING; Labeling	SUPPL	46	AP	2011-10-18	UNKNOWN
REMS; REMS	SUPPL	49	AP	2011-08-03	N/A
LABELING; Labeling	SUPPL	50	AP	2011-10-18	UNKNOWN
LABELING; Labeling	SUPPL	52	AP	2012-08-24	STANDARD
LABELING; Labeling	SUPPL	53	AP	2012-12-18	STANDARD
LABELING; Labeling	SUPPL	54	AP	2013-08-14	901 REQUIRED
LABELING; Labeling	SUPPL	55	AP	2014-11-20	STANDARD
EFFICACY; Efficacy	SUPPL	56	AP	2015-05-08	STANDARD
EFFICACY; Efficacy	SUPPL	57	AP	2016-09-27	PRIORITY
LABELING; Labeling	SUPPL	58	AP	2016-09-27	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; Labeling	SUPPL	59	AP	2016-07-26	STANDARD
LABELING; Labeling	SUPPL	60	AP	2018-10-18	STANDARD
LABELING; Labeling	SUPPL	61	AP	2019-05-03	STANDARD
LABELING; Labeling	SUPPL	62	AP	2020-05-06	STANDARD

Submissions Property Types

SUPPL	5	Null	0
SUPPL	36	Null	7
SUPPL	38	Null	6
SUPPL	39	Null	6
SUPPL	40	Null	6
SUPPL	41	Null	6
SUPPL	46	Null	15
SUPPL	49	Null	7
SUPPL	50	Null	7
SUPPL	52	Null	7
SUPPL	53	Null	7
SUPPL	54	Null	15
SUPPL	55	Null	6
SUPPL	56	Null	7
SUPPL	57	Null	4
SUPPL	58	Null	7
SUPPL	59	Null	15
SUPPL	60	Null	6
SUPPL	61	Null	6
SUPPL	62	Null	6

CDER Filings

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            [products] => []
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