Active substance
Choline fenofibrate
- US FDA 13
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| FENOFIBRIC ACID | EQ 45MG FENOFIBRIC ACID; EQ 135MG FENOFIBRIC ACID | capsule, delayed release · oral | CHARTWELL RX | Prescription | 4 Dec 2013 |
| FENOFIBRIC ACID | EQ 45MG FENOFIBRIC ACID; EQ 135MG FENOFIBRIC ACID | capsule, delayed release · oral | ACTAVIS ELIZABETH | Prescription | 7 Oct 2015 |
| FENOFIBRIC ACID | EQ 45MG FENOFIBRIC ACID; EQ 135MG FENOFIBRIC ACID | capsule, delayed release · oral | IMPAX LABS INC | Prescription | 7 Sep 2016 |
| FENOFIBRIC ACID | EQ 45MG FENOFIBRIC ACID; EQ 135MG FENOFIBRIC ACID | capsule, delayed release · oral | ALEMBIC | Prescription | 12 May 2017 |
| FENOFIBRIC ACID | EQ 45MG FENOFIBRIC ACID; EQ 135MG FENOFIBRIC ACID | capsule, delayed release · oral | RISING | Prescription | 18 Jul 2019 |
| FENOFIBRIC ACID | EQ 45MG FENOFIBRIC ACID; EQ 135MG FENOFIBRIC ACID | capsule, delayed release · oral | AUROBINDO PHARMA LTD | Prescription | 25 Jul 2019 |
| FENOFIBRIC ACID | EQ 45MG FENOFIBRIC ACID; EQ 135MG FENOFIBRIC ACID | capsule, delayed release · oral | YICHANG HUMANWELL | Prescription | 23 Dec 2020 |
| TRILIPIX | EQ 45MG FENOFIBRIC ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 135MG FENOFIBRIC ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | capsule, delayed release · oral | ABBVIE | Discontinued | 15 Dec 2008 |
| FENOFIBRIC ACID | EQ 45MG FENOFIBRIC ACID; EQ 135MG FENOFIBRIC ACID | capsule, delayed release · oral | PHARMOBEDIENT | Discontinued | 25 Mar 2013 |
| FENOFIBRIC ACID | EQ 135MG FENOFIBRIC ACID; EQ 45MG FENOFIBRIC ACID | capsule, delayed release · oral | PH HEALTH | Discontinued | 18 Jul 2013 |
| FENOFIBRIC ACID | EQ 45MG FENOFIBRIC ACID; EQ 135MG FENOFIBRIC ACID | capsule, delayed release · oral | TWI PHARMS | Discontinued | 5 Jul 2019 |
| FENOFIBRIC ACID | EQ 45MG FENOFIBRIC ACID; EQ 135MG FENOFIBRIC ACID | capsule, delayed release · oral | MICRO LABS | Discontinued | 16 Jun 2020 |
| FENOFIBRIC ACID | EQ 45MG FENOFIBRIC ACID; EQ 135MG FENOFIBRIC ACID | capsule, delayed release · oral | MACLEODS PHARMS | Discontinued | 8 Feb 2024 |
Safety signals and safety-related labeling changes
- US FDA 6 Jun 2025 TRILIPIX — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.