Triglide

NDA 21350, held by Jagotec. Fenofibrate.

As of Nov 14, 2026, NDA 21350 (Triglide), held by Jagotec, was first approved by FDA on May 7, 2005, with 11 approved supplements and 0 published complete response letters.

First approved: May 7, 2005
Review: Standard
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
May 7, 2005	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Triglide50MG · tablet;oral	Fenofibrate	Discontinued
Triglide160MG · tablet;oral	Fenofibrate	DiscontinuedReference drug

All 12 submissions, including labeling and manufacturing supplements


May 14, 2024	Supplement 24Labeling · Standard review	Approved	Letter Label
Jun 3, 2021	Supplement 23Labeling	Approved	Label Letter
May 15, 2019	Supplement 22Labeling	Approved	Label
May 18, 2018	Supplement 20Labeling	Approved	Label Letter
Nov 13, 2015	Supplement 15Labeling · Standard review	Approved	Letter
Apr 15, 2015	Supplement 14Labeling · Standard review	Approved	Letter Label
Jan 15, 2013	Supplement 13Labeling · Standard review	Approved	Label Letter
Apr 19, 2012	Supplement 10Labeling	Approved	Letter Label
Nov 17, 2008	Supplement 8Labeling · Standard review	Approved	Label Letter
Jan 15, 2008	Supplement 5Labeling · Standard review	Approved	Letter Label
Jul 3, 2006	Supplement 2Labeling · Standard review	Approved	Letter Label
May 7, 2005	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21350
Drugs@FDA: Overview at FDA
Company: Jagotec

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters