Application 017481

Type: NDA
Sponsor: JANSSEN PHARMS

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001	VERMOX	MEBENDAZOLE	TABLET, CHEWABLE;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017481-001	VERMOX	MEBENDAZOLE	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL		RLD, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N017481-001	VERMOX	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017481-001	VERMOX	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017481-001	VERMOX	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD, Approved before 1982	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VERMOX	MEBENDAZOLE	Janssen Pharmaceuticals, Inc.	a720c424-517a-461b-8e13-6c37caf8aa3f	2021-10-05	Warnings, Adverse reactions	Name fallback brand name: VERMOX generic name: MEBENDAZOLE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

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

Documents#

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