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FDA NDA · NDA021350

TRIGLIDE

Sponsor: JAGOTEC

APPLICATION
NDA021350
TYPE
NDA
ORIGINAL APPROVAL
2005-05-07
LATEST ACTION
2024-05-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TRIGLIDE · ReferenceDiscontinued
FENOFIBRATE 160MG · TABLET · ORAL
TRIGLIDEDiscontinued
FENOFIBRATE 50MG · TABLET · ORAL

Approval history

2024-05-14Labeling · Supplement 24 · standard — Label ↗AP
2021-06-03Labeling · Supplement 23 · 901 required — Letter ↗AP
2019-05-15Labeling · Supplement 22 · 901 required — Label ↗AP
2018-05-18Labeling · Supplement 20 · 901 required — Letter ↗AP
2015-11-13Labeling · Supplement 15 · standard — Letter ↗AP
2015-04-15Labeling · Supplement 14 · standard — Letter ↗AP
2013-01-15Labeling · Supplement 13 · standard — Label ↗AP
2012-04-19Labeling · Supplement 10 · unknown — Letter ↗AP
2008-11-17Labeling · Supplement 8 · standard — Label ↗AP
2008-01-15Labeling · Supplement 5 · standard — Letter ↗AP
2006-07-03Labeling · Supplement 2 · standard — Letter ↗AP
2005-05-07Type 3 - New Dosage Form · Original · standard — Review ↗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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