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NDA

MEBENDAZOLE | N017481 | JANSSEN PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain6 active DMFs4 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

CIPLA LTDMEBENDAZOLE USP

DMF 71711987

SHAANXI HANJIANG PHARMACEUTICAL GROUP CO LTDMEBENDAZOLE POLYMORPH C

DMF 303252016

MSN LIFE SCIENCES PRIVATE LTDMEBENDAZOLE USP

DMF 319452017

OPTIMUS DRUGS PRIVATE LTDMEBENDAZOLE FORM-A

DMF 320162017

MSN LIFE SCIENCES PRIVATE LTDMEBENDAZOLE USP (CRYSTALLINE)

DMF 331502018

SOLARA ACTIVE PHARMA SCIENCES LTDMEBENDAZOLE USP

DMF 354152020

CADILA LABORATORIES PVT LTDInactiveMEBENDAZOLE

DMF 78041988

GUILIN PHARMACEUTICAL FACTORYInactiveMEBENDAZOLE

DMF 96551992

JANSSEN PHARMACEUTICA NVInactiveMEBENDAZOLE POLYMORPH B DRUG SUBSTANCE

DMF 106001993

JANSSEN PHARMACEUTICA NVInactiveMEBENDAZOLE POLYMORH C

DMF 108601994

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 16, 2017	SUPPL -47	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET, CHEWABLE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.