Details for New Drug Application (NDA): 017481

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NDA 017481 describes VERMOX, which is a drug marketed by Janssen Pharms and is included in two NDAs. It is available from two suppliers. Additional details are available on the VERMOX profile page.

The generic ingredient in VERMOX is mebendazole. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the mebendazole profile page.

Summary for 017481

Tradename:	VERMOX
Applicant:	Janssen Pharms
Ingredient:	mebendazole
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 017481

Medical Subject Heading (MeSH) Categories for 017481

Antinematodal Agents
Tubulin Modulators

Suppliers and Packaging for NDA: 017481

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VERMOX	mebendazole	TABLET, CHEWABLE;ORAL	017481	NDA	Johnson & Johnson Consumer Inc, McNeil Consumer Healthcare Division	50580-070	50580-070-12	1 BLISTER PACK in 1 CARTON (50580-070-12) > 12 TABLET, CHEWABLE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, CHEWABLE;ORAL			Strength	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 017481

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	VERMOX	mebendazole	TABLET, CHEWABLE;ORAL	017481-001	Approved Prior to Jan 1, 1982	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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