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MESANTOIN

NDA

MEPHENYTOIN | N006008 | NOVARTIS PHARMACEUTICALS CORP

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Schiff & Company - Citizen Petition FDA-2008-P-0560 · 5 docket documents Schiff & Company, representing JFAS LLC, filed this citizen petition requesting that the FDA Commissioner determine whether Mesantoin (mephenytoin) 100 mg tablets, NDA 006008, manufactured by Novartis, was voluntarily withdrawn for reasons unrelated to safety and effectiveness, pursuant to Section 5	Other	2008-11-13	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

1 trial from ClinicalTrials.gov

Trial	Phase	Status	Sponsor	Enrollment	Dates
Metabolic Capacity of Israeli Populations NCT00162383	N/A	UNKNOWN	Hadassah Medical Organization	1,200	1995-07 → 2020-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Products (1)

#001 — 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.