Application 208398

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	500MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N208398-001	VERMOX	MEBENDAZOLE	500MG	TABLET, CHEWABLE / ORAL		RLD	2016-10-19

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N208398-001	VERMOX	500MG	TABLET, CHEWABLE / ORAL	RLD	2016-10-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208398-001	VERMOX	500MG	TABLET, CHEWABLE / ORAL	RLD	2016-10-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208398-001	VERMOX	500MG	TABLET, CHEWABLE / ORAL	RLD	2016-10-19	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N208398-001	VERMOX	500MG	TABLET, CHEWABLE / ORAL	RLD	2016-10-19	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208398-001	NS	2019-10-19	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N208398-001	NS	2019-10-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208398-001	NS	2019-10-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208398-001	NS	2019-10-19	`ea99ee380514…`

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	Exact identifier application applno (NDA): 208398 application number: NDA208398 ndc (product): 50458-675

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50458-675	VERMOX	mebendazole	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-675	VERMOX	mebendazole	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-675	VERMOX	mebendazole	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-675	VERMOX	mebendazole	Janssen Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68691	SUPPL	2021-09-21
46615	ORIG	2016-12-30
46614	ORIG	2016-12-30
45686	ORIG	2016-10-27
45628	ORIG	2016-10-21