JANSSEN PHARMS FDA Approval NDA 021721

Application #021721

Documents

Letter	2004-10-29
Letter	2004-12-02
Letter	2006-06-28
Letter	2007-06-04
Letter	2007-05-16
Letter	2007-07-05
Letter	2007-11-19
Letter	2007-11-19
Letter	2009-05-05
Letter	2011-03-03
Letter	2013-08-16
Letter	2016-07-26
Label	2004-11-01
Label	2007-06-04
Label	2007-09-19
Label	2007-11-19
Label	2008-06-05
Label	2011-10-12
Review	2007-04-20
Review	2015-03-10
Review	2012-06-22
Summary Review	2008-07-16
Summary Review	2015-03-10
Letter	2005-08-08
Letter	2006-01-30
Letter	2007-09-25
Letter	2007-09-25
Letter	2008-05-08
Letter	2008-01-09
Letter	2008-04-18
Letter	2008-10-07
Letter	2009-03-13
Letter	2011-06-14
Letter	2012-05-01
Letter	2011-10-13
Letter	2011-10-13
Letter	2014-05-28
Label	2005-08-08
Label	2004-12-03
Label	2006-01-27
Label	2006-06-28
Label	2007-09-19
Label	2007-05-16
Label	2007-06-27
Label	2007-11-19
Label	2007-12-14
Label	2008-10-08
Label	2009-05-11
Label	2011-03-04
Label	2011-06-14
Label	2012-04-30
Label	2011-10-12
Label	2013-08-15
Label	2014-05-28
Label	2016-07-26
Review	2012-06-22
Medication Guide	2009-11-19
Letter	2017-02-09
Label	2017-02-10
Pediatric Medical Review	1900-01-01
Pediatric Written Request	1900-01-01
Pediatric Amendment 1	1900-01-01
Pediatric Clinical Pharmacology Review	1900-01-01
Pediatric Statistical Review	1900-01-01

Application Sponsors

NDA 021721

JANSSEN PHARMS

Marketing Status

Discontinued

001

Application Products

001

SOLUTION;ORAL

250MG/10ML

LEVAQUIN

LEVOFLOXACIN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2004-10-21	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	2005-08-04	UNKNOWN
EFFICACY; Efficacy	SUPPL	3	AP	2004-11-24	PRIORITY
LABELING; Labeling	SUPPL	6	AP	2006-01-20	STANDARD
LABELING; Labeling	SUPPL	7	AP	2006-06-23	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	2007-09-14	UNKNOWN
LABELING; Labeling	SUPPL	10	AP	2007-05-31	STANDARD
EFFICACY; Efficacy	SUPPL	11	AP	2007-09-11	PRIORITY
LABELING; Labeling	SUPPL	12	AP	2007-05-10	STANDARD
LABELING; Labeling	SUPPL	13	AP	2007-06-19	STANDARD
EFFICACY; Efficacy	SUPPL	15	AP	2008-05-05	UNKNOWN
LABELING; Labeling	SUPPL	16	AP	2007-11-15	STANDARD
LABELING; Labeling	SUPPL	17	AP	2007-11-16	STANDARD
LABELING; Labeling	SUPPL	18	AP	2007-12-13	STANDARD
LABELING; Labeling	SUPPL	19	AP	2008-04-16	STANDARD
LABELING; Labeling	SUPPL	20	AP	2008-10-03	STANDARD
LABELING; Labeling	SUPPL	21	AP	2009-04-27	STANDARD
LABELING; Labeling	SUPPL	22	AP	2009-03-12	STANDARD
LABELING; Labeling	SUPPL	25	AP	2011-02-25	901 REQUIRED
LABELING; Labeling	SUPPL	26	AP	2011-06-09	STANDARD
EFFICACY; Efficacy	SUPPL	28	AP	2012-04-27	PRIORITY
LABELING; Labeling	SUPPL	29	AP	2011-10-11	UNKNOWN
REMS; REMS	SUPPL	31	AP	2011-10-11	N/A
LABELING; Labeling	SUPPL	32	AP	2013-08-14	901 REQUIRED
LABELING; Labeling	SUPPL	33	AP	2014-05-23	STANDARD
LABELING; Labeling	SUPPL	34	AP	2016-07-26	STANDARD
LABELING; Labeling	SUPPL	35	AP	2017-02-08	STANDARD

Submissions Property Types

SUPPL	3	Null	41
SUPPL	11	Null	26
SUPPL	21	Null	7
SUPPL	25	Null	6
SUPPL	26	Null	6
SUPPL	28	Null	21
SUPPL	29	Null	15
SUPPL	31	Null	7
SUPPL	32	Null	15
SUPPL	33	Null	6
SUPPL	34	Null	6
SUPPL	35	Null	7

CDER Filings

JANSSEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21721
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/ucm088619.pdf"]
            [products] => [{"drugName":"LEVAQUIN","activeIngredients":"LEVOFLOXACIN","strength":"250MG\/10ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"02\/08\/2017","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020634s068,020635s074,021721s035lbl.pdf\"}]","notes":""},{"actionDate":"07\/26\/2016","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020634s067,020635s073,021721s034lbl.pdf\"}]","notes":""},{"actionDate":"05\/23\/2014","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020634s066,020635s072,021721s033lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2013","submission":"SUPPL-32","supplementCategories":"Labeling-Package 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020634s058,020635s064,021721s025lbl.pdf\"}]","notes":""},{"actionDate":"02\/25\/2011","submission":"SUPPL-25","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020634s058,020635s064,021721s025lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2009","submission":"SUPPL-21","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"04\/27\/2009","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"10\/03\/2008","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020634s044,020635s047,021721s012lbl.pdf\"}]","notes":""},{"actionDate":"06\/23\/2006","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020634s040,020635s043,021721s007lbl.pdf\"}]","notes":""},{"actionDate":"01\/20\/2006","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020634s039,020635s042,021721s006lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2005","submission":"SUPPL-2","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label 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            [originalApprovals] => [{"actionDate":"LEVAQUIN","submission":"LEVOFLOXACIN","actionType":"250MG\/10ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-02-08
        )

)

NDA 021721

JANSSEN PHARMS

FDA Drug Application

Application #021721

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

JANSSEN PHARMS