Application Nr Approved Date Route Status External Links
ANDA076056 2006-04-24 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & 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. 1.1 Prevention Of Cardiovascular Disease In Hypercholesterolemic Patients Without Clinically Evident Coronary Heart Disease (chd), Pravastatin Sodium Tablets Usp Are Indicated To: Reduce The Risk Of Myocardial Infarction (mi). Reduce The Risk Of Undergoing Myocardial Revascularization Procedures. Reduce The Risk Of Cardiovascular Mortality With No Increase In Death From Non-Cardiovascular Causes. 1.2 Hyperlipidemia Pravastatin Sodium Tablets Usp Are Indicated: As An Adjunct To Diet To Reduce Elevated Total Cholesterol (total-C), Low-Density Lipoprotein Cholesterol (ldl-C), Apolipoprotein B (apob), And Triglyceride (tg) Levels And To Increase High-Density Lipoprotein Cholesterol (hdl-C) In Patients With Primary Hypercholesterolemia And Mixed Dyslipidemia (fredrickson Types Iia And Iib).1 As An Adjunct To Diet For The Treatment Of Patients With Elevated Serum Tg Levels (fredrickson Type Iv). For The Treatment Of Patients With Primary Dysbetalipoproteinemia (fredrickson Type Iii) Who Do Not Respond Adequately To Diet. As An Adjunct To Diet And Lifestyle Modification For Treatment Of Heterozygous Familial Hypercholesterolemia (hefh) In Children And Adolescent Patients Ages 8 Years And Older If After An Adequate Trial Of Diet The Following Findings Are Present: A. Ldl-C Remains ≥ 190 Mg/dl Or B. Ldl-C Remains ≥ 160 Mg/dl And: There Is A Positive Family History Of Premature Cardiovascular Disease (cvd) Or Two Or More Other Cvd Risk Factors Are Present In The Patient. 1.3 Limitations Of Use Pravastatin Sodium Tablets Usp Have Not Been Studied In Conditions Where The Major Lipoprotein Abnormality Is Elevation Of Chylomicrons (fredrickson Types I And V).

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
2. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
3. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Pravastatin Sodium PRAVASTATIN SODIUM ZINC3798763

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