JANSSEN PHARMS Application 017481

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VERMOX	MEBENDAZOLE	TABLET, CHEWABLE;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50580-070	VERMOX	mebendazole	Johnson & Johnson Consumer Inc, McNeil Consumer Healthcare Division	NDA	Current

Document, Submission type, Date table
Document	Submission type	Date
48750	SUPPL	2017-06-16
48716	SUPPL	2017-06-14