Application Nr Approved Date Route Status External Links
ANDA202968 2017-04-26 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Therapy With Lipid-Altering Agents Should Be Only One Component Of Multiple Risk Factor Intervention In Individuals At Significantly Increased Risk For Atherosclerotic Vascular Disease Due To Hypercholesterolemia. Drug Therapy Is Indicated As An Adjunct To Diet When The Response To A Diet Restricted In Saturated Fat And Cholesterol And Other Nonpharmacologic Measures Alone Has Been Inadequate. Ezetimibe And Simvastatin Tablets, Which Contain A Cholesterol Absorption Inhibitor And An Hmg-Coa Reductase Inhibitor (statin), Is Indicated As Adjunctive Therapy To Diet To: Reduce Elevated Total-C, Ldl-C, Apo B, Tg, And Non-Hdl-C, And To Increase Hdl-C In Patients With Primary (heterozygous Familial And Non-Familial) Hyperlipidemia Or Mixed Hyperlipidemia. (1.1) Reduce Elevated Total-C And Ldl-C In Patients With Homozygous Familial Hypercholesterolemia (hofh), As An Adjunct To Other Lipid-Lowering Treatments. (1.2) Limitations Of Use (1.3) No Incremental Benefit Of Ezetimibe And Simvastatin Tablets On Cardiovascular Morbidity And Mortality Over And Above That Demonstrated For Simvastatin Has Been Established. Ezetimibe And Simvastatin Tablets Have Not Been Studied In Fredrickson Type I, Iii, Iv, And V Dyslipidemias. 1.1 Primary Hyperlipidemia Ezetimibe And Simvastatin Tablets Are Indicated For The Reduction Of Elevated Total Cholesterol (total-C), Low-Density Lipoprotein Cholesterol (ldl-C), Apolipoprotein B (apo B), Triglycerides (tg), And Non-High-Density Lipoprotein Cholesterol (non-Hdl-C), And To Increase High-Density Lipoprotein Cholesterol (hdl-C) In Patients With Primary (heterozygous Familial And Non-Familial) Hyperlipidemia Or Mixed Hyperlipidemia. 1.2 Homozygous Familial Hypercholesterolemia (hofh) Ezetimibe And Simvastatin Tablets Are Indicated For The Reduction Of Elevated Total-C And Ldl-C In Patients With Homozygous Familial Hypercholesterolemia, As An Adjunct To Other Lipid-Lowering Treatments (e.g., Ldl Apheresis) Or If Such Treatments Are Unavailable. 1.3 Limitations Of Use No Incremental Benefit Of Ezetimibe And Simvastatin Tablets On Cardiovascular Morbidity And Mortality Over And Above That Demonstrated For Simvastatin Has Been Established. Ezetimibe And Simvastatin Tablets Have Not Been Studied In Fredrickson Type I, Iii, Iv, And V Dyslipidemias.

All Formulated Excipients (11 Total)

Name Structure Kind Function Status
1. Ascorbic Acid ASCORBIC ACID Molecular DS-Dietary supplement , MISC-Miscellaneous , NUTR-Nutrient , PRES-Chemical preservative FS-Substances permitted as optional ingredient in a standardized food.
2. Butylated Hydroxyanisole BUTYLATED HYDROXYANISOLE Molecular
3. Anhydrous Citric Acid ANHYDROUS CITRIC ACID Molecular
4. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
5. Hypromelloses HYPROMELLOSES Unresolved
6. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
7. Ferric Oxide Red FERRIC OXIDE RED Molecular
8. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
9. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
10. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
11. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Ezetimibe EZETIMIBE ZINC3810860
2. Simvastatin SIMVASTATIN ZINC3780893

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