NDA 018533

JANSSEN PHARMS

FDA Drug Application

Application #018533

Documents

• Letter: 2013-07-29
• Label: 2014-03-05
• Letter: 2014-02-27
• Label: 2013-07-25
• Medication Guide: 2013-07-25
• Other Important Information from FDA: 2014-02-07

Application Sponsors

NDA 018533

JANSSEN PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

NIZORAL

KETOCONAZOLE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1981-06-12	PRIORITY
LABELING; Labeling	SUPPL	2	AP	1983-06-23	PRIORITY
LABELING; Labeling	SUPPL	3	AP	1986-06-30	PRIORITY
LABELING; Labeling	SUPPL	4	AP	1983-06-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1983-04-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1983-04-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1983-09-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1984-07-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1984-07-09	PRIORITY
LABELING; Labeling	SUPPL	11	AP	1986-06-30	PRIORITY
LABELING; Labeling	SUPPL	12	AP	1986-06-30	PRIORITY
LABELING; Labeling	SUPPL	13	AP	1986-06-30	PRIORITY
LABELING; Labeling	SUPPL	14	AP	1986-06-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1985-06-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1988-05-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1988-07-08	PRIORITY
LABELING; Labeling	SUPPL	18	AP	1989-04-14	PRIORITY
LABELING; Labeling	SUPPL	19	AP	1991-03-15	PRIORITY
LABELING; Labeling	SUPPL	20	AP	1992-12-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1992-10-13	PRIORITY
LABELING; Labeling	SUPPL	22	AP	1992-12-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1993-09-20	PRIORITY
LABELING; Labeling	SUPPL	24	AP	1994-03-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1995-09-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1995-09-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1995-09-15	PRIORITY
LABELING; Labeling	SUPPL	29	AP	1996-07-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1996-04-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1996-06-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1998-03-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1998-05-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1998-07-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1999-04-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1999-09-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2002-04-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	2002-08-13	PRIORITY
LABELING; Labeling	SUPPL	40	AP	2013-07-25	PRIORITY
LABELING; Labeling	SUPPL	41	AP	2014-02-25	PRIORITY

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	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	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0

CDER Filings

JANSSEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18533
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/UCM362592.pdf"]
            [products] => [{"drugName":"NIZORAL","activeIngredients":"KETOCONAZOLE","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"}]
            [labels] => [{"actionDate":"02\/25\/2014","submission":"SUPPL-41","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/018533s041lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2013","submission":"SUPPL-40","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/018533s040lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NIZORAL","submission":"KETOCONAZOLE","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"}]
            [supplements] => 
            [actionDate] => 2014-02-25
        )

)