NDA 017481

JANSSEN PHARMS

FDA Drug Application

Application #017481

Documents

• Label: 2017-06-14
• Letter: 2017-06-16

Application Sponsors

NDA 017481

JANSSEN PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, CHEWABLE;ORAL

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

VERMOX

MEBENDAZOLE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1974-06-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1976-03-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1975-10-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1975-10-30	PRIORITY
LABELING; Labeling	SUPPL	6	AP	1976-03-18
LABELING; Labeling	SUPPL	7	AP	1977-03-04
LABELING; Labeling	SUPPL	8	AP	1977-07-29
LABELING; Labeling	SUPPL	9	AP	1977-08-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1978-04-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1978-10-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1979-02-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1979-09-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1979-03-08	PRIORITY
LABELING; Labeling	SUPPL	16	AP	1979-03-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1980-04-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1980-04-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1980-04-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1980-12-29	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1981-06-04	PRIORITY
LABELING; Labeling	SUPPL	25	AP	1983-07-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1983-03-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1983-03-16	PRIORITY
LABELING; Labeling	SUPPL	28	AP	1984-05-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1984-08-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1984-08-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1986-01-26	PRIORITY
LABELING; Labeling	SUPPL	34	AP	1989-09-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1993-01-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1993-01-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1993-12-23	PRIORITY
LABELING; Labeling	SUPPL	38	AP	1998-02-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1994-06-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1995-09-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1998-03-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1998-05-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1998-07-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1998-10-20	PRIORITY
LABELING; Labeling	SUPPL	47	AP	2017-06-13	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	29	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	47	Null	7

CDER Filings

JANSSEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17481
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VERMOX","activeIngredients":"MEBENDAZOLE","strength":"100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"06\/13\/2017","submission":"SUPPL-47","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/017481s047lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"VERMOX","submission":"MEBENDAZOLE","actionType":"100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-06-13
        )

)