NDA 019384

MERCK

FDA Drug Application

Application #019384

Documents

• Letter: 2001-04-23
• Letter: 2004-07-28
• Letter: 2004-07-28
• Letter: 2004-07-28
• Letter: 2007-03-15
• Letter: 2008-10-07
• Letter: 2011-06-17
• Letter: 2011-09-13
• Letter: 2012-02-13
• Letter: 2013-03-29
• Letter: 2013-08-16
• Letter: 2016-07-26
• Label: 2004-07-28
• Label: 2004-07-28
• Label: 2006-05-18
• Label: 2006-09-25
• Label: 2008-10-09
• Label: 2009-05-11
• Label: 2011-11-04
• Label: 2011-09-20
• Label: 2012-02-10
• Label: 2012-06-18
• Label: 2013-04-01
• Label: 2013-08-15
• Label: 2016-07-26
• Letter: 2001-04-23
• Letter: 2001-04-23
• Letter: 2006-05-21
• Letter: 2006-09-27
• Letter: 2008-09-26
• Letter: 2009-02-13
• Letter: 2009-05-04
• Letter: 2011-03-03
• Letter: 2011-05-31
• Letter: 2011-10-20
• Letter: 2011-09-21
• Letter: 2012-06-18
• Review: 2008-04-04
• Review: 2008-04-04
• Review: 2008-04-04
• Review: 2008-04-04
• Medication Guide: 2013-08-16
• Other: 2011-03-15
• Label: 2004-07-28
• Label: 2008-10-03
• Label: 2011-03-04
• Review: 2008-04-04
• Review: 2008-04-04
• Review: 2008-04-04
• Review: 2008-04-04
• Review: 2008-04-04
• Review: 1990-11-19

Application Sponsors

NDA 019384

MERCK

Marketing Status

• Discontinued: 002

Application Products

002

TABLET;ORAL

400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

NOROXIN

NORFLOXACIN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1986-10-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1987-03-18	PRIORITY
LABELING; Labeling	SUPPL	3	AP	1988-01-28
LABELING; Labeling	SUPPL	5	AP	1988-01-28
LABELING; Labeling	SUPPL	6	AP	1988-01-28
EFFICACY; Efficacy	SUPPL	7	AP	1991-11-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1988-06-28	PRIORITY
LABELING; Labeling	SUPPL	9	AP	1991-11-26
EFFICACY; Efficacy	SUPPL	11	AP	1991-11-26
LABELING; Labeling	SUPPL	12	AP	1991-11-26
LABELING; Labeling	SUPPL	13	AP	1991-11-26
LABELING; Labeling	SUPPL	14	AP	1991-11-26
LABELING; Labeling	SUPPL	15	AP	1991-11-26
LABELING; Labeling	SUPPL	16	AP	1992-04-17
LABELING; Labeling	SUPPL	18	AP	1992-03-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1992-05-06	PRIORITY
EFFICACY; Efficacy	SUPPL	20	AP	1994-10-24
LABELING; Labeling	SUPPL	21	AP	1993-06-29
LABELING; Labeling	SUPPL	24	AP	1994-07-01	STANDARD
LABELING; Labeling	SUPPL	26	AP	1998-02-09	STANDARD
LABELING; Labeling	SUPPL	27	AP	1995-11-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1995-12-26	PRIORITY
LABELING; Labeling	SUPPL	29	AP	1996-09-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1996-07-18	PRIORITY
LABELING; Labeling	SUPPL	31	AP	1997-01-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1996-06-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1996-07-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1996-12-06	PRIORITY
LABELING; Labeling	SUPPL	36	AP	1997-06-20	STANDARD
LABELING; Labeling	SUPPL	37	AP	2001-04-16	STANDARD
LABELING; Labeling	SUPPL	38	AP	2001-04-16	STANDARD
LABELING; Labeling	SUPPL	39	AP	2001-04-16	STANDARD
LABELING; Labeling	SUPPL	40	AP	2004-07-23	STANDARD
LABELING; Labeling	SUPPL	42	AP	2004-07-23	STANDARD
LABELING; Labeling	SUPPL	43	AP	2004-07-23	STANDARD
LABELING; Labeling	SUPPL	45	AP	2006-05-16	STANDARD
LABELING; Labeling	SUPPL	46	AP	2006-09-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	2007-03-20	N/A
LABELING; Labeling	SUPPL	48	AP	2007-03-14	STANDARD
LABELING; Labeling	SUPPL	49	AP	2008-09-23	STANDARD
LABELING; Labeling	SUPPL	50	AP	2008-09-23	PRIORITY
LABELING; Labeling	SUPPL	52	AP	2008-10-03	STANDARD
LABELING; Labeling	SUPPL	53	AP	2009-02-12	STANDARD
LABELING; Labeling	SUPPL	54	AP	2009-04-27	STANDARD
LABELING; Labeling	SUPPL	55	AP	2011-06-10	UNKNOWN
LABELING; Labeling	SUPPL	56	AP	2011-02-25	901 REQUIRED
LABELING; Labeling	SUPPL	58	AP	2011-09-08	N/A
LABELING; Labeling	SUPPL	59	AP	2011-05-27	UNKNOWN
LABELING; Labeling	SUPPL	60	AP	2011-10-18	UNKNOWN
LABELING; Labeling	SUPPL	61	AP	2011-09-16	UNKNOWN
LABELING; Labeling	SUPPL	62	AP	2012-02-09	STANDARD
LABELING; Labeling	SUPPL	63	AP	2012-06-15	STANDARD
LABELING; Labeling	SUPPL	65	AP	2013-03-27	STANDARD
LABELING; Labeling	SUPPL	66	AP	2013-08-14	STANDARD
LABELING; Labeling	SUPPL	67	AP	2016-07-26	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	8	Null	0
SUPPL	19	Null	0
SUPPL	28	Null	0
SUPPL	30	Null	0
SUPPL	32	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	50	Null	0
SUPPL	54	Null	7
SUPPL	55	Null	6
SUPPL	56	Null	6
SUPPL	58	Null	15
SUPPL	59	Null	6
SUPPL	60	Null	6
SUPPL	61	Null	6
SUPPL	62	Null	6
SUPPL	63	Null	7
SUPPL	65	Null	6
SUPPL	66	Null	7
SUPPL	67	Null	15

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19384
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)