NDA 019927

JANSSEN PHARMS

FDA Drug Application

Application #019927

Documents

• Label: 2012-12-05
• Label: 2013-10-31
• Letter: 2012-12-05
• Letter: 2013-10-30
• Other Important Information from FDA: 2014-02-07
• Label: 2009-09-17

Application Sponsors

NDA 019927

JANSSEN PHARMS

Marketing Status

• Prescription: 001

Application Products

001

SHAMPOO;TOPICAL

2%

1

NIZORAL

KETOCONAZOLE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1990-08-31	STANDARD
LABELING; Labeling	SUPPL	2	AP	1995-03-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1992-09-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1993-07-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1993-10-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1995-11-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1995-10-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1995-11-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1996-02-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1995-11-02	STANDARD
LABELING; Labeling	SUPPL	11	AP	1996-04-25	STANDARD
EFFICACY; Efficacy	SUPPL	12	AP	1997-05-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1996-07-09	STANDARD
LABELING; Labeling	SUPPL	14	AP	1997-10-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1998-02-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1998-05-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1998-05-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1999-02-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2002-02-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2002-05-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2002-10-02	STANDARD
LABELING; Labeling	SUPPL	28	AP	2009-08-07	STANDARD
LABELING; Labeling	SUPPL	31	AP	2012-12-04	UNKNOWN
LABELING; Labeling	SUPPL	32	AP	2013-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2013-06-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2014-01-08	STANDARD

Submissions Property Types

SUPPL	1	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	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	28	Null	7
SUPPL	31	Null	6
SUPPL	32	Null	7
SUPPL	33	Null	0
SUPPL	34	Null	0

TE Codes

001

Prescription

AB

CDER Filings

JANSSEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19927
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"NIZORAL","activeIngredients":"KETOCONAZOLE","strength":"2%","dosageForm":"SHAMPOO;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/29\/2013","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019927s032lbl.pdf\"}]","notes":""},{"actionDate":"12\/04\/2012","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019927s031lbl.pdf\"}]","notes":""},{"actionDate":"08\/07\/2009","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019927s028lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NIZORAL","submission":"KETOCONAZOLE","actionType":"2%","submissionClassification":"SHAMPOO;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2013-10-29
        )

)