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PHENURONE

NDA

PHENACEMIDE | N007707 | ABBVIE 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Schiff & Company - Citizen Petition FDA-2008-P-0558 · 5 docket documents Schiff & Company, representing JFAS LLC, filed this petition under Section 505(j)(2)(C) requesting that the FDA determine whether Phenurone (phenacemide) 500 mg tablets, NDA 007707, manufactured by Abbott, was voluntarily withdrawn for reasons unrelated to safety and effectiveness, to establish whet	Other	2008-10-22	Granted	—

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Products (1)

#001 — 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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.