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Fenofibrate

Generic Name
Fenofibrate
Brand Names
Antara, Cholib, Fenoglide, Fenomax, Lipidil Supra, Lipofen, Tricor, Triglide
Drug Type
Small Molecule
Chemical Formula
C20H21ClO4
CAS Number
49562-28-9
Unique Ingredient Identifier
U202363UOS

Overview

Fenofibrate is a fibric acid derivative like clofibrate and gemfibrozil. Fenofibrate is used to treat primary hypercholesterolemia, mixed dyslipidemia, severe hypertriglyceridemia. Fenofibrate was granted FDA approval on 31 December 1993.

Background

Fenofibrate is a fibric acid derivative like clofibrate and gemfibrozil. Fenofibrate is used to treat primary hypercholesterolemia, mixed dyslipidemia, severe hypertriglyceridemia. Fenofibrate was granted FDA approval on 31 December 1993.

Indication

Fenofibrate is indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, Triglycerides, and Apo B, and to increase HDL-C adults with primary hypercholesterolemia or mixed dyslipidemia. Fenofibrate is also indicated to treat adults with severe hypertriglyceridemia.

Associated Conditions

  • Mixed Dyslipidemias
  • Primary Hypercholesterolemia
  • Severe Hypertriglyceridemia (sHTG)
  • Severe Fredrickson Type IV Hypertriglyceridemia
  • Severe Fredrickson Type V Hypertriglyceridemia

FDA Approved Products

fenofibrate
Manufacturer:Glenmark Pharmaceuticals Inc., USA
Route:ORAL
Strength:200 mg in 1 1
Approved: 2021/08/06
NDC:68462-582
Fenofibrate
Manufacturer:American Health Packaging
Route:ORAL
Strength:145 mg in 1 1
Approved: 2024/02/20
NDC:60687-629
FENOFIBRATE
Manufacturer:Alembic Pharmaceuticals Inc.
Route:ORAL
Strength:145 mg in 1 1
Approved: 2022/09/23
NDC:62332-361
fenofibrate
Manufacturer:Glenmark Pharmaceuticals Inc., USA
Route:ORAL
Strength:67 mg in 1 1
Approved: 2021/08/06
NDC:68462-580
Fenofibrate
Manufacturer:A-S Medication Solutions
Route:ORAL
Strength:54 mg in 1 1
Approved: 2020/07/01
NDC:50090-3842

Singapore Approved Products

CHOLIB FILM-COATED TABLET 145MG/20MG
Manufacturer:Fournier Laboratories Ireland Limited, Mylan Laboratoires SAS (Primary & Secondary)
Form:TABLET, FILM COATED
Strength:145.0mg
Online:Yes
Approved: 2019/04/09
Approval:SIN15664P
EP-FENO TABLET 145MG
Manufacturer:Ethypharm (Chateauneuf en Thymerais) (manufacture of tablets), Aesica Pharmaceuticals S.R.L. (Primary packager and Secondary packager), Ethypharm Grand Quevilly (manufacture of granulates)
Form:TABLET
Strength:145 mg
Online:Yes
Approved: 2021/04/14
Approval:SIN16155P
PRAVAFEN HARD CAPSULES 40mg/160mg
Manufacturer:SMB Technology S.A.
Form:CAPSULE
Strength:160mg
Online:Yes
Approved: 2014/02/21
Approval:SIN14508P

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