BAYER HLTHCARE FDA Approval NDA 019537

Application #019537

Documents

Letter	2000-08-30
Letter	2004-03-28
Letter	2004-03-28
Letter	2004-03-28
Letter	2004-07-21
Letter	2005-11-18
Letter	2008-10-07
Letter	2009-02-18
Letter	2009-06-30
Letter	2011-11-21
Letter	2011-08-08
Letter	2013-08-16
Letter	2015-02-12
Label	2002-04-17
Label	2004-04-05
Label	2004-07-21
Label	2007-06-27
Label	2008-01-23
Label	2008-10-09
Label	2009-02-20
Label	2011-03-04
Label	2013-02-01
Label	2013-08-15
Letter	2002-04-17
Letter	2002-12-16
Letter	2004-03-28
Letter	2005-01-11
Letter	2004-07-21
Letter	2005-05-20
Letter	2006-06-28
Letter	2007-07-05
Letter	2008-01-22
Letter	2009-05-07
Letter	2009-04-10
Letter	2011-03-02
Letter	2011-06-14
Letter	2011-10-20
Letter	2013-01-31
Letter	2016-07-26
Review	2008-08-11
Review	2007-07-09
Review	2008-04-04
Review	2007-07-09
Review	2012-09-17
Label	2000-08-30
Label	2004-04-05
Label	2004-04-05
Label	2004-04-05
Label	2005-01-11
Label	2004-07-21
Label	2005-05-20
Label	2005-11-17
Label	2009-05-11
Label	2009-04-16
Label	2011-11-16
Label	2011-06-14
Label	2011-11-04
Label	2015-03-02
Label	2016-07-26
Review	2004-09-29
Review	2004-10-08
Review	2008-04-04
Review	2008-08-11
Review	2007-07-09
Review	2008-08-11
Review	2000-08-30
Review	2008-04-04
Review	2007-07-09
Review	2007-11-19
Review	2008-04-04
Review	2007-11-19
Review	2008-04-04
Review	2007-11-19
Review	2007-11-19
Review	2008-04-04
Review	2008-04-04
Review	2012-09-17
Letter	2016-09-19
Label	2016-09-19
Label	2017-07-27
Letter	2017-07-28
Pediatric Medical Review	1900-01-01
Pediatric Written Request	1900-01-01
Pediatric Amendment 1	1900-01-01
Pediatric Amendment 2	1900-01-01
Pediatric Clinical Pharmacology Review	1900-01-01
Pediatric Statistical Review	1900-01-01
Label	2018-10-19
Letter	2018-10-23
Letter	2019-05-06
Letter	2019-05-06
Label	2019-05-08
Label	2020-03-06
Medication Guide	2020-03-06
Letter	2020-03-06
Letter	2020-05-11
Label	2020-05-12
Medication Guide	2020-05-12
Letter	2021-03-31
Label	2021-04-01
Medication Guide	2021-04-01
Letter	2021-11-12
Label	2021-11-12
Medication Guide	2021-11-12

Application Sponsors

NDA 019537

BAYER HLTHCARE

Marketing Status

Discontinued	001
Prescription	002
Prescription	003
Discontinued	004

Application Products

001	TABLET;ORAL	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	1	CIPRO	CIPROFLOXACIN HYDROCHLORIDE
002	TABLET;ORAL	EQ 250MG BASE	1	CIPRO	CIPROFLOXACIN HYDROCHLORIDE
003	TABLET;ORAL	EQ 500MG BASE	1	CIPRO	CIPROFLOXACIN HYDROCHLORIDE
004	TABLET;ORAL	EQ 750MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	1	CIPRO	CIPROFLOXACIN HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1987-10-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1988-02-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1988-10-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1988-11-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1989-10-25	PRIORITY
LABELING; Labeling	SUPPL	8	AP	1993-01-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1991-11-19	PRIORITY
EFFICACY; Efficacy	SUPPL	13	AP	1994-07-21
EFFICACY; Efficacy	SUPPL	15	AP	1994-07-21
EFFICACY; Efficacy	SUPPL	16	AP	1997-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1992-09-10	PRIORITY
LABELING; Labeling	SUPPL	18	AP	2011-10-18	PRIORITY
EFFICACY; Efficacy	SUPPL	19	AP	1995-09-13	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1994-03-14	PRIORITY
EFFICACY; Efficacy	SUPPL	21	AP	1996-09-11	STANDARD
EFFICACY; Efficacy	SUPPL	22	AP	1996-10-10	UNKNOWN
LABELING; Labeling	SUPPL	25	AP	1997-09-26	STANDARD
EFFICACY; Efficacy	SUPPL	26	AP	1996-04-08	UNKNOWN
EFFICACY; Efficacy	SUPPL	27	AP	1998-04-03	UNKNOWN
LABELING; Labeling	SUPPL	28	AP	1996-11-22	STANDARD
EFFICACY; Efficacy	SUPPL	29	AP	1997-06-03	UNKNOWN
LABELING; Labeling	SUPPL	30	AP	1998-09-17	STANDARD
LABELING; Labeling	SUPPL	31	AP	1998-09-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1998-11-18	PRIORITY
LABELING; Labeling	SUPPL	33	AP	1998-09-17	STANDARD
LABELING; Labeling	SUPPL	34	AP	2000-06-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1999-06-09	PRIORITY
LABELING; Labeling	SUPPL	36	AP	2000-06-28	STANDARD
EFFICACY; Efficacy	SUPPL	38	AP	2000-08-30	PRIORITY
LABELING; Labeling	SUPPL	39	AP	2000-06-28	STANDARD
LABELING; Labeling	SUPPL	40	AP	2000-06-28	STANDARD
LABELING; Labeling	SUPPL	41	AP	2002-04-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	2001-12-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	2002-12-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	2002-08-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	2002-12-10	PRIORITY
LABELING; Labeling	SUPPL	48	AP	2004-03-15	STANDARD
EFFICACY; Efficacy	SUPPL	49	AP	2004-03-25	PRIORITY
LABELING; Labeling	SUPPL	50	AP	2004-03-15	STANDARD
LABELING; Labeling	SUPPL	51	AP	2004-03-15	STANDARD
EFFICACY; Efficacy	SUPPL	52	AP	2005-01-07	UNKNOWN
LABELING; Labeling	SUPPL	53	AP	2004-07-14	STANDARD
LABELING; Labeling	SUPPL	54	AP	2004-07-14	STANDARD
LABELING; Labeling	SUPPL	57	AP	2005-05-18	STANDARD
LABELING; Labeling	SUPPL	60	AP	2005-11-09	STANDARD
LABELING; Labeling	SUPPL	62	AP	2006-06-19	STANDARD
LABELING; Labeling	SUPPL	65	AP	2007-06-25	STANDARD
LABELING; Labeling	SUPPL	67	AP	2008-01-18	STANDARD
LABELING; Labeling	SUPPL	68	AP	2008-10-03	STANDARD
LABELING; Labeling	SUPPL	69	AP	2009-02-13	STANDARD
LABELING; Labeling	SUPPL	70	AP	2009-04-27	STANDARD
LABELING; Labeling	SUPPL	71	AP	2009-06-24	STANDARD
LABELING; Labeling	SUPPL	73	AP	2009-04-06	STANDARD
LABELING; Labeling	SUPPL	74	AP	2011-11-15	UNKNOWN
LABELING; Labeling	SUPPL	75	AP	2011-02-25	901 REQUIRED
LABELING; Labeling	SUPPL	78	AP	2011-06-10	UNKNOWN
REMS; REMS	SUPPL	79	AP	2011-08-03	N/A
LABELING; Labeling	SUPPL	80	AP	2011-10-18	UNKNOWN
LABELING; Labeling	SUPPL	81	AP	2013-01-30	STANDARD
LABELING; Labeling	SUPPL	82	AP	2013-08-14	901 REQUIRED
EFFICACY; Efficacy	SUPPL	83	AP	2015-02-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	84	AP	2014-11-21	PRIORITY
LABELING; Labeling	SUPPL	85	AP	2016-09-14	STANDARD
LABELING; Labeling	SUPPL	86	AP	2016-07-26	STANDARD
LABELING; Labeling	SUPPL	87	AP	2017-07-26	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; Labeling	SUPPL	88	AP	2018-10-18	STANDARD
LABELING; Labeling	SUPPL	89	AP	2019-05-03	STANDARD
LABELING; Labeling	SUPPL	90	AP	2020-03-05	STANDARD
LABELING; Labeling	SUPPL	91	AP	2020-05-08	STANDARD
LABELING; Labeling	SUPPL	92	AP	2021-11-11	STANDARD
LABELING; Labeling	SUPPL	93	AP	2021-03-30	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0
SUPPL	32	Null	0
SUPPL	35	Null	0
SUPPL	38	Null	41
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	48	Null	9
SUPPL	49	Null	8
SUPPL	70	Null	7
SUPPL	74	Null	6
SUPPL	75	Null	7
SUPPL	78	Null	6
SUPPL	79	Null	6
SUPPL	80	Null	6
SUPPL	81	Null	6
SUPPL	82	Null	6
SUPPL	83	Null	20
SUPPL	84	Null	0
SUPPL	85	Null	15
SUPPL	86	Null	6
SUPPL	87	Null	6
SUPPL	88	Null	7
SUPPL	89	Null	7
SUPPL	90	Null	33
SUPPL	91	Null	6
SUPPL	92	Null	6
SUPPL	93	Null	15

TE Codes

002	Prescription	AB
003	Prescription	AB

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19537
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

NDA 019537

BAYER HLTHCARE

FDA Drug Application

Application #019537

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

TE Codes

CDER Filings