← FDA DRUG APPROVALS

FDA NDA · NDA022224

TRILIPIX

Sponsor: ABBVIE

APPLICATION
NDA022224
TYPE
NDA
ORIGINAL APPROVAL
2008-12-15
LATEST ACTION
2025-06-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

TRILIPIX · ReferenceDiscontinued
CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, DELAYED RELEASE · ORAL
TRILIPIX · ReferenceDiscontinued
CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2025-06-06Labeling · Supplement 18 · standard — Label ↗AP
2021-06-03Labeling · Supplement 16 · standard — Label ↗AP
2021-06-03Labeling · Supplement 17 · 901 required — Label ↗AP
2019-03-28Labeling · Supplement 15 · standard — Letter ↗AP
2018-11-07Labeling · Supplement 14 · standard — Label ↗AP
2018-05-18Labeling · Supplement 13 · 901 required — Letter ↗AP
2015-11-18Manufacturing (CMC) · Supplement 12 · standardAP
2015-04-27Labeling · Supplement 11 · standard — Letter ↗AP
2015-04-17Manufacturing (CMC) · Supplement 10 · standardAP
2013-01-28Manufacturing (CMC) · Supplement 9 · standardAP
2012-09-05Manufacturing (CMC) · Supplement 7 · standard — Letter ↗AP
2012-09-05Labeling · Supplement 8 · unknown — Letter ↗AP
2011-09-30Labeling · Supplement 5 · 901 required — Label ↗AP
2011-09-30REMS · Supplement 6 — Label ↗AP
2011-03-14Labeling · Supplement 4 · unknown — Letter ↗AP
2010-09-14Labeling · Supplement 3 · unknown — Label ↗AP
2008-12-15Type 2 - New Active Ingredient · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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