Application Nr Approved Date Route Status External Links
ANDA076433 2005-05-13 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Fenofibrate Tablets, Usp Is A Peroxisome Proliferator Receptor Alpha (pparĪ±) Activator Indicated As An Adjunct To Diet: To Reduce Elevated Ldl-C, Total-C, Tg And Apo B, And To Increase Hdl-C In Adult Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia (1.1). For Treatment Of Adult Patients With Severe Hypertriglyceridemia (1.2). Important Limitations Of Use: Fenofibrate Was Not Shown To Reduce Coronary Heart Disease Morbidity And Mortality In Patients With Type 2 Diabetes Mellitus (5.1). 1.1 Primary Hypercholesterolemia Or Mixed Dyslipidemia Fenofibrate Tablets, Usp Are Indicated As Adjunctive Therapy To Diet To Reduce Elevated Low-Density Lipoprotein Cholesterol (ldl-C), Total Cholesterol (total-C), Triglycerides And Apolipoprotein B (apo B), And To Increase High-Density Lipoprotein Cholesterol (hdl-C) In Adult Patients With Primary Hypercholesterolemia Or Mixed Dyslipidemia. 1.2 Severe Hypertriglyceridemia Fenofibrate Tablets, Usp Are Also Indicated As Adjunctive Therapy To Diet For Treatment Of Adult Patients With Severe Hypertriglyceridemia. Improving Glycemic Control In Diabetic Patients Showing Fasting Chylomicronemia Will Usually Obviate The Need For Pharmacologic Intervention. Markedly Elevated Levels Of Serum Triglycerides (e.g., > 2,000 Mg/dl) May Increase The Risk Of Developing Pancreatitis. The Effect Of Fenofibrate Therapy On Reducing This Risk Has Not Been Adequately Studied. 1.3 Important Limitations Of Use Fenofibrate At A Dose Equivalent To 145 Mg Of Fenofibrate Tablets, Usp Was Not Shown To Reduce Coronary Heart Disease Morbidity And Mortality In A Large, Randomized Controlled Trial Of Patients With Type 2 Diabetes Mellitus [see Warnings And Precautions (5.1)].

All Formulated Excipients (13 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
4. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
5. Lecithin LECITHIN Unresolved
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
8. Povidones POVIDONES Unresolved
9. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
10. Sodium Stearyl Fumarate SODIUM STEARYL FUMARATE Molecular MISC-Miscellaneous , STAB-Stabilizer REG-Food additives for which a petition has been filed and a regulation issued.
11. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
12. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
13. Xanthan Gum XANTHAN GUM Unresolved EMUL-Emulsifier FS-Substances permitted as optional ingredient in a standardized food.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Fenofibrate FENOFIBRATE ZINC584092

Comments