Chemical Structure (Arava 01)
Chemical structure of leflunomide, the active ingredient in Arava, showing its molecular composition and arrangement of atoms.*
Arava Tablet, Film Coated
Product Images NDC 0088-2162
9 FDA label images from Sanofi-aventis U.s. Llc · Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Arava (NDC 0088-2162). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Sanofi-aventis U.s. Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
Product Images & Figures Index
Chemical Structure (Arava 02)
Chemical structure of teriflunomide, labeled as A77 1726, which is related to leflunomide. The structure shows aromatic and functional groups including a trifluoromethyl-substituted benzene ring and a nitrile group.*
Figure 1 (Arava 03)
A bar chart titled '% ACR 20 Responder at Endpoint' showing response percentages for three trials comparing leflunomide (L), methotrexate (M), sulfasalazine (S), and placebo (P). The x-axis lists Trial 1 (12 months), Trial 2 (6 months), and Trial 3 (12 months), and the y-axis shows percentage from -20 to 70. Each trial displays bars representing treatment groups with corresponding response percentages labeled above each bar.*
Figure 2 (Arava 04)
A line graph titled 'Trial 1 ACR Responders Over Time' showing the percentage of responders on the y-axis (ranging from -10 to 70) and months on the x-axis (0 to 12). It compares response rates over time for PL, MTX, and LEF groups, with LEF reaching the highest percentage of responders around 50%. The graph includes a note that last observation carried forward was used.*
Figure 3 (Arava 05)
A bar chart titled 'Change in Sharp Score' presents data from three clinical trials over 6 to 12 months. The vertical axis represents progression, with bars showing the effect of leflunomide, methotrexate, sulfasalazine, and placebo on Sharp Score changes. Labels identify each treatment with associated score values.*
Figure 4 (Arava 06)
A bar chart titled 'Change in Functional Ability Measure' showing improvement over three clinical trials (Trial 1: 12 months, Trial 2: 6 months, Trial 3: 12 months). The chart presents changes measured by the HAQ Disability Index for four treatments: Leflunomide (L), Methotrexate (M), Placebo (P), and Sulfasalazine (S). Each trial compares bars representing each treatment's improvement, with Leflunomide consistently showing the greatest improvement across trials.*
Principal Display Panel (10 mg Carton)
Packaging label for Arava Tablets leflunomide 10 mg film-coated tablets. The label indicates 30 tablets per container, manufactured by sanofi-aventis U.S. LLC. It includes storage instructions, dosage reference, and a warning to keep out of reach of children. The package mentions an oversized container for ease of patient use and displays the NDC 0088-2160-30.*
Principal Display Panel (20 mg Carton)
Packaging label for Arava Tablets leflunomide 20 mg film-coated tablets, oral use. The label indicates a package size of 30 tablets, with warnings to keep out of children's reach and storage instructions at 25°C (77°F). Manufactured by sanofi-aventis U.S. LLC, the label also notes an oversized container for patient ease and specifies the origin as France.*
Principal Display Panel (100 mg Carton)
Arava Tablets 100 mg Initiation-Dose Kit packaging label for oral film-coated tablets containing leflunomide. The box shows brand and generic names, strength, and dosing instructions for the first days of therapy. It indicates the kit includes three 100-mg tablets and labels the product as a physician sample, not for sale. The labeler is sanofi-aventis U.S. LLC.*
* 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.
