NDA 020083

JANSSEN PHARMS

FDA Drug Application

Application #020083

Documents

• Letter: 2004-07-21
• Letter: 2004-07-21
• Letter: 2009-03-10
• Letter: 2010-08-03
• Letter: 2012-04-23
• Letter: 2014-06-11
• Label: 2002-07-17
• Label: 2002-04-11
• Label: 2002-07-17
• Label: 2004-07-21
• Label: 2009-03-17
• Label: 2010-07-31
• Label: 2012-04-20
• Label: 2012-04-20
• Label: 2014-06-10
• Letter: 2002-07-17
• Letter: 2002-04-11
• Letter: 2002-07-17
• Letter: 2003-11-25
• Letter: 2009-03-10
• Letter: 2009-03-10
• Letter: 2012-04-23
• Letter: 2012-04-23
• Letter: 2015-04-17
• Label: 2003-04-24
• Label: 2003-12-02
• Label: 2004-07-21
• Label: 2009-03-17
• Label: 2009-03-17
• Label: 2012-04-20
• Label: 2015-04-17
• Label: 2017-03-23
• Letter: 2017-03-24
• Label: 2017-10-10
• Letter: 2017-10-12
• Label: 2018-05-10
• Letter: 2018-05-10
• Letter: 2019-03-11
• Label: 2019-03-11
• Letter: 2022-12-06
• Label: 2022-12-07

Application Sponsors

NDA 020083

JANSSEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

100MG

1

SPORANOX

ITRACONAZOLE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1992-09-11	PRIORITY
LABELING; Labeling	SUPPL	2	AP	1992-12-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1993-06-09
EFFICACY; Efficacy	SUPPL	4	AP	1994-03-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1994-05-09
LABELING; Labeling	SUPPL	6	AP	1993-11-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1994-10-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1995-09-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1995-09-15
LABELING; Labeling	SUPPL	12	AP	1996-05-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1996-03-22
LABELING; Labeling	SUPPL	17	AP	1996-12-10	STANDARD
LABELING; Labeling	SUPPL	18	AP	1997-08-06	STANDARD
LABELING; Labeling	SUPPL	19	AP	1997-08-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1997-11-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1998-07-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1998-07-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1999-02-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1999-09-29
LABELING; Labeling	SUPPL	25	AP	2001-05-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2001-03-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2002-02-27
LABELING; Labeling	SUPPL	28	AP	2002-07-17	STANDARD
LABELING; Labeling	SUPPL	29	AP	2002-04-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2002-10-10
LABELING; Labeling	SUPPL	31	AP	2002-07-17	STANDARD
LABELING; Labeling	SUPPL	33	AP	2003-11-10	STANDARD
LABELING; Labeling	SUPPL	34	AP	2004-07-14	STANDARD
LABELING; Labeling	SUPPL	35	AP	2004-07-14	STANDARD
LABELING; Labeling	SUPPL	40	AP	2009-03-05	STANDARD
LABELING; Labeling	SUPPL	41	AP	2009-03-05	STANDARD
LABELING; Labeling	SUPPL	44	AP	2009-03-05	STANDARD
LABELING; Labeling	SUPPL	46	AP	2010-07-29	UNKNOWN
LABELING; Labeling	SUPPL	48	AP	2012-04-18	UNKNOWN
LABELING; Labeling	SUPPL	49	AP	2012-04-18	STANDARD
LABELING; Labeling	SUPPL	50	AP	2012-04-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	2013-03-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	2013-06-05
LABELING; Labeling	SUPPL	53	AP	2014-06-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	2014-04-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	2014-06-13
LABELING; Labeling	SUPPL	58	AP	2015-04-16	STANDARD
LABELING; Labeling	SUPPL	60	AP	2017-03-17	STANDARD
LABELING; Labeling	SUPPL	61	AP	2017-10-07	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; Labeling	SUPPL	62	AP	2018-05-08	STANDARD
LABELING; Labeling	SUPPL	63	AP	2019-03-08	STANDARD
LABELING; Labeling	SUPPL	65	AP	2022-12-05	STANDARD

Submissions Property Types

ORIG	1	Null	11
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	16	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	30	Null	0
SUPPL	35	Null	9
SUPPL	46	Null	7
SUPPL	48	Null	7
SUPPL	49	Null	7
SUPPL	50	Null	15
SUPPL	51	Null	0
SUPPL	52	Null	0
SUPPL	53	Null	6
SUPPL	54	Null	0
SUPPL	55	Null	0
SUPPL	58	Null	7
SUPPL	60	Null	7
SUPPL	61	Null	7
SUPPL	62	Null	7
SUPPL	63	Null	15
SUPPL	65	Null	6

TE Codes

001

Prescription

AB

CDER Filings

JANSSEN PHARMS

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            [docInserts] => ["",""]
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            [labels] => [{"actionDate":"03\/08\/2019","submission":"SUPPL-63","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020083s063lbl.pdf\"}]","notes":""},{"actionDate":"05\/08\/2018","submission":"SUPPL-62","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020083s062lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2017","submission":"SUPPL-61","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020083s061,020657s036lbl.pdf\"}]","notes":"Please see"},{"actionDate":"03\/17\/2017","submission":"SUPPL-60","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20083s25lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SPORANOX","submission":"ITRACONAZOLE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-03-08
        )

)