Request that the FDA determine that the listed RLD product FENOGLIDE (fenofibrate) Tablets, 40 mg and 120 mg, N022118, NDA Holder– Salix Pharmaceuticals INC, was not discontinued for safety or effectiveness reasons | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2026-P-0655

Request that the FDA determine that the listed RLD product FENOGLIDE (fenofibrate) Tablets, 40 mg and 120 mg, N022118, NDA Holder– Salix Pharmaceuticals INC, was not discontinued for safety or effectiveness reasons

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensJan 21, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Final Response	Apr 30, 2026	--

Keywords

CDER

Citizen Petion

Foley & Lardner, LLP

determine that the listed RLD product

FENOGLIDE (fenofibrate) Tablets,

40 mg and 120 mg, N022118, NDA Holder

Salix Pharmaceuticals INC, was not discontinued

for safety or effectiveness reasons

Data from Regulations.gov