NDA 020966

JANSSEN PHARMS

FDA Drug Application

Application #020966

Documents

• Letter: 1999-03-30
• Letter: 2001-04-17
• Letter: 2001-04-17
• Letter: 2002-07-17
• Letter: 2004-07-21
• Letter: 2009-03-10
• Letter: 2009-04-27
• Label: 1999-03-30
• Label: 2001-04-17
• Label: 2009-04-03
• Label: 2009-04-28
• Review: 2001-10-26
• Review: 2001-10-26
• Letter: 2001-04-17
• Letter: 2002-02-28
• Letter: 2009-03-10
• Letter: 2009-03-10
• Label: 2001-04-17
• Label: 2001-04-17
• Label: 2002-07-17
• Label: 2004-07-21
• Label: 2009-04-03
• Label: 2009-04-03
• Review: 2003-08-13
• Review: 2001-10-26

Application Sponsors

NDA 020966

JANSSEN PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

0

SPORANOX

ITRACONAZOLE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1999-03-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1999-10-25	STANDARD
LABELING; Labeling	SUPPL	3	AP	2001-05-09	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2001-05-09	STANDARD
LABELING; Labeling	SUPPL	5	AP	2002-02-28	STANDARD
LABELING; Labeling	SUPPL	6	AP	2002-07-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-08-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-08-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-09-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-10-10	STANDARD
LABELING; Labeling	SUPPL	11	AP	2004-07-14	STANDARD
LABELING; Labeling	SUPPL	17	AP	2009-03-05	STANDARD
LABELING; Labeling	SUPPL	18	AP	2009-03-05	STANDARD
LABELING; Labeling	SUPPL	20	AP	2009-03-05	STANDARD
LABELING; Labeling	SUPPL	22	AP	2009-04-23	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	0

CDER Filings

JANSSEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20966
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"SPORANOX","activeIngredients":"ITRACONAZOLE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/23\/2009","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020966s022lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2009","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020966s017s018s020lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2009","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020966s017s018s020lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2009","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020966s017s018s020lbl.pdf\"}]","notes":""},{"actionDate":"07\/14\/2004","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20966s011lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2002","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20966s6lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2001","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2001\\\/20-966S001_Sporanox_prntlbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2001","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2001\\\/20-966S001_Sporanox_prntlbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2001","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2001\\\/20-966S001_Sporanox_prntlbl.pdf\"}]","notes":""},{"actionDate":"03\/30\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/20966lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SPORANOX","submission":"ITRACONAZOLE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2009-04-23
        )

)