NDA 019735

JANSSEN PHARMS

FDA Drug Application

Application #019735

Documents

• Letter: 2006-06-20
• Letter: 2007-05-29
• Letter: 2008-01-09
• Letter: 2008-10-07
• Letter: 2009-02-13
• Letter: 2011-03-03
• Label: 2006-01-27
• Label: 2007-05-29
• Letter: 2004-03-10
• Letter: 2004-09-17
• Letter: 2004-09-17
• Letter: 2006-01-30
• Letter: 2007-07-05
• Review: 2006-05-10
• Review: 2006-05-10
• Review: 2006-05-10
• Review: 2008-04-04
• Review: 2008-04-04
• Review: 2009-09-16
• Label: 2004-04-05
• Label: 2004-09-17
• Label: 2004-09-17
• Label: 2006-06-20
• Label: 2007-06-27
• Label: 2007-12-14
• Label: 2008-10-09
• Label: 2011-03-04
• Review: 2006-05-10
• Review: 2006-05-10
• Review: 2008-04-04
• Review: 2008-04-04
• Review: 2009-09-16
• Medication Guide: 2011-03-04

Application Sponsors

NDA 019735

JANSSEN PHARMS

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	FLOXIN	OFLOXACIN
002	TABLET;ORAL	300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	FLOXIN	OFLOXACIN
003	TABLET;ORAL	400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	FLOXIN	OFLOXACIN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1990-12-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1991-12-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1992-05-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1992-06-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1993-09-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1992-07-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1992-12-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1992-09-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1993-08-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1992-09-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1992-09-03	STANDARD
LABELING; Labeling	SUPPL	24	AP	1994-07-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1993-11-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1993-11-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1993-11-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1993-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1995-01-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1994-08-08	STANDARD
LABELING; Labeling	SUPPL	38	AP	1996-09-11	STANDARD
LABELING; Labeling	SUPPL	39	AP	1997-08-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1995-09-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1995-11-09	STANDARD
EFFICACY; Efficacy	SUPPL	42	AP	1996-12-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1996-06-28	STANDARD
LABELING; Labeling	SUPPL	44	AP	1998-09-21	STANDARD
LABELING; Labeling	SUPPL	45	AP	1999-12-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1999-03-25	STANDARD
LABELING; Labeling	SUPPL	47	AP	1999-12-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1999-09-08	STANDARD
LABELING; Labeling	SUPPL	49	AP	1999-12-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	2000-10-30	STANDARD
LABELING; Labeling	SUPPL	51	AP	2004-03-06	STANDARD
LABELING; Labeling	SUPPL	52	AP	2004-09-15	STANDARD
LABELING; Labeling	SUPPL	53	AP	2004-09-15	STANDARD
LABELING; Labeling	SUPPL	54	AP	2006-01-20	STANDARD
LABELING; Labeling	SUPPL	55	AP	2006-06-14	STANDARD
LABELING; Labeling	SUPPL	56	AP	2007-05-16	STANDARD
LABELING; Labeling	SUPPL	57	AP	2007-06-19	STANDARD
LABELING; Labeling	SUPPL	58	AP	2007-12-13	STANDARD
LABELING; Labeling	SUPPL	59	AP	2008-10-03	STANDARD
LABELING; Labeling	SUPPL	60	AP	2009-02-12	STANDARD
LABELING; Labeling	SUPPL	61	AP	2011-02-25	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	47	Null	0
SUPPL	48	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0
SUPPL	51	Null	0
SUPPL	52	Null	0
SUPPL	53	Null	0
SUPPL	54	Null	0
SUPPL	55	Null	0
SUPPL	56	Null	0
SUPPL	57	Null	0
SUPPL	58	Null	0
SUPPL	59	Null	0
SUPPL	60	Null	0
SUPPL	61	Null	0

CDER Filings

JANSSEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19735
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2011\/019735s061MedG.pdf"]
            [products] => [{"drugName":"FLOXIN","activeIngredients":"OFLOXACIN","strength":"200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"FLOXIN","activeIngredients":"OFLOXACIN","strength":"300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"FLOXIN","activeIngredients":"OFLOXACIN","strength":"400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"02\/25\/2011","submission":"SUPPL-61","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/019735s061lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2008","submission":"SUPPL-59","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/019735s059lbl.pdf\"}]","notes":""},{"actionDate":"12\/13\/2007","submission":"SUPPL-58","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019735s058lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2007","submission":"SUPPL-57","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019735s057lbl.pdf\"}]","notes":""},{"actionDate":"05\/16\/2007","submission":"SUPPL-56","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/019735s056lbl.pdf\"}]","notes":""},{"actionDate":"06\/14\/2006","submission":"SUPPL-55","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/019735s055lbl.pdf\"}]","notes":""},{"actionDate":"01\/20\/2006","submission":"SUPPL-54","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/019735s054LBL.pdf\"}]","notes":""},{"actionDate":"09\/15\/2004","submission":"SUPPL-53","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/19735s052,053lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2004","submission":"SUPPL-52","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/19735s052,053lbl.pdf\"}]","notes":""},{"actionDate":"03\/06\/2004","submission":"SUPPL-51","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/19735slr051_floxin_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FLOXIN","submission":"OFLOXACIN","actionType":"200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"FLOXIN","submission":"OFLOXACIN","actionType":"300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"FLOXIN","submission":"OFLOXACIN","actionType":"400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2011-02-25
        )

)