Fluvastatin Sodium Tablet, Film Coated, Extended Release
Product Images NDC 0093-7446

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Fluvastatin Sodium (NDC 0093-7446). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Teva Pharmaceuticals Usa, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Fluvastatin Sodium Structural Formula (Image 1)

Chemical structure diagram of fluvastatin sodium, showing its molecular framework including fluorophenyl and indole groups, along with hydroxyl substitutions and the sodium ion.*

FDA Label Image

Figure 1: Primary Endpoint – Recurrent Cardiac Events (cardiac Death, Nonfatal Mi Or Revascularization Procedure) (itt Population) (Image 2)

A survival curve chart comparing the percentage of patients without events over time between Fluvastatin 80 mg and placebo groups. The x-axis shows years since randomization up to 4.5 years, and the y-axis shows the percentage of patients without events from 70% to 100%. The chart includes statistics for Cox P-Value, Log-Rank P-Value, and Hazard Ratio with confidence intervals.*

FDA Label Image

Figure 2: Fluvastatin Capsules Intervention Prevention Study (Primary and Secondary Endpoints)

A forest plot chart showing incidence and risk reduction comparing fluvastatin capsules to placebo in cardiac event outcomes. It includes data on primary and secondary endpoints such as cardiac death, nonfatal MI, and revascularization with corresponding risk reduction percentages and confidence intervals. The horizontal axis indicates risk ratios favoring fluvastatin capsules on the left and placebo on the right.*

FDA Label Image

Figure 3: Change In Minimum Lumen Diameter (mm) (Image 4)

A bar chart depicting the change in minimum lumen diameter (mm) comparing Fluvastatin capsules versus placebo capsules under different therapy conditions: Monotherapy, All Patients, and Combination Therapy with cholestyramine (CME). The chart shows negative changes for both treatments, with values provided for each group and sample sizes noted below bars.*

FDA Label Image

Figure 4: Change In % Diameter Stenosis (Image 5)

Bar chart showing the percentage change in diameter stenosis comparing Fluvastatin capsules and Placebo groups with sample sizes noted. The chart includes data for Monotherapy, All Patients, and Combination Therapy with cholestyramine (CME), with p-values indicating statistical comparisons between groups.*

FDA Label Image

80 mg, 30 Tablets Label (Image 6)

Fluvastatin Sodium Extended-Release Tablets 80 mg film-coated, extended-release oral tablets, labeled by Teva Pharmaceuticals USA, Inc. The package contains 30 tablets. The label includes the NDC 0093-7446-56 and a pharmacist instruction to dispense with the attached patient information leaflet. The Teva logo is visible on the label.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.