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FDA NDA · NDA022118

FENOGLIDE

Sponsor: SALIX

APPLICATION
NDA022118
TYPE
NDA
ORIGINAL APPROVAL
2007-08-10
LATEST ACTION
2025-06-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

FENOGLIDE · ReferenceDiscontinued
FENOFIBRATE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
FENOGLIDE · ReferenceDiscontinued
FENOFIBRATE 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2025-06-06Labeling · Supplement 14 · standard — Label ↗AP
2021-06-03Labeling · Supplement 13 · 901 required — Label ↗AP
2019-05-15Labeling · Supplement 10 · 901 required — Letter ↗AP
2019-03-13Labeling · Supplement 9 · standard — Letter ↗AP
2018-05-18Labeling · Supplement 7 · 901 required — Letter ↗AP
2012-10-31Labeling · Supplement 5 · standard — Letter ↗AP
2012-03-05Labeling · Supplement 3 · standard — Letter ↗AP
2008-02-29Labeling · Supplement 1 · standard — Letter ↗AP
2007-08-10Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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