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Medicines · US (FDA)

FDA 2020

FDA

Fenofibric Acid

Approved 16 Jun 2020OralCapsule, delayed release

The FDA lists this product in 24 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID · Capsule, delayed releaseANDA200750-002 · Prescription
CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID · Capsule, delayed releaseANDA200750-001 · Prescription
CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID · Capsule, delayed releaseANDA207796-002 · Discontinued
CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID · Capsule, delayed releaseANDA207796-001 · Discontinued
CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID · Capsule, delayed releaseANDA200264-002 · Prescription
CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID · Capsule, delayed releaseANDA200264-001 · Prescription
CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID · Capsule, delayed releaseANDA200920-002 · Prescription
CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID · Capsule, delayed releaseANDA200920-001 · Prescription
CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID · Capsule, delayed release

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

ANDA213450-002 · Prescription

CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID · Capsule, delayed releaseThis page

CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID · Capsule, delayed releaseANDA200913-002 · Discontinued

CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID · Capsule, delayed releaseANDA200913-001 · Discontinued

CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID · Capsule, delayed releaseANDA201573-001 · Discontinued

CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID · Capsule, delayed releaseANDA201573-002 · Discontinued

CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID · Capsule, delayed releaseANDA208705-001 · Prescription

CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID · Capsule, delayed releaseANDA208705-002 · Prescription

CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID · Capsule, delayed releaseANDA210469-001 · Discontinued

CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID · Capsule, delayed releaseANDA210469-002 · Discontinued

CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID · Capsule, delayed releaseANDA211626-001 · Prescription

CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID · Capsule, delayed releaseANDA211626-002 · Prescription

CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID · Capsule, delayed releaseANDA212562-002 · Prescription

CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID · Capsule, delayed releaseANDA212562-001 · Prescription

CHOLINE FENOFIBRATE EQ 45MG FENOFIBRIC ACID · Capsule, delayed releaseANDA212598-001 · Prescription

CHOLINE FENOFIBRATE EQ 135MG FENOFIBRIC ACID · Capsule, delayed releaseANDA212598-002 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA213450.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Fenofibric Acid
Active substance: choline fenofibrate
Route: Oral
Dosage form: Capsule, delayed release
Applicant: Micro Labs
Status: Prescription
FDA approval: 16 Jun 2020
Application: ANDA213450-001