Arava Tablet, Film Coated
Product Images NDC 0088-2161

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Arava (NDC 0088-2161). 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.

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Chemical Structure (Arava 01)

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Chemical Structure (Arava 02)

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Figure 1 (Arava 03)

The given text provides data that deals with the percentage of ACR 20 Responder at Endpoint. The data seems to refer to a clinical trial or study with three trials being conducted, the duration of which ranges from six months to twelve months. The percentage of ACR20 response rate is either 66% or 85% depending upon the duration of the trial. However, the context does not provide more information on what ACR 20 Responder represents. And, the included information doesn't provide any clear meaning or purpose.*

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Figure 2 (Arava 04)

This text seems to be part of a graph or chart describing the percentage of ACR (American College of Rheumatology) responders over time in a medical trial. Without more context or data, it is not possible to give a more specific description of the graph or its results.*

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Figure 3 (Arava 05)

This text seems to be a table or chart with three different trials, each with a duration of either 6 or 12 months, and some numerical data labeled "123", "216", "232", and "248". Additionally, there are four different abbreviations: "L" for Leflunomide, "M" for methotrexate, "S" for sulfasalazine, and "P" for placebo. The only phrase with any meaning seems to be "Change in Sharp Score," which likely refers to a measurement or assessment of some kind. Based on this limited information, it is not clear what the purpose or context of this table is, or what conclusions can be drawn from it.*

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Figure 4 (Arava 06)

This text appears to be a table displaying the change in functional ability measure over the course of 12 months for trial 1 and 6 months for trial 2. The table lists different medications used in the trials, including Leflunomide, Methotrexate, Placebo, and Sulfasalazine. The measurement used to assess functional ability is the HAQ Disability Index. However, it is unclear what the specific values in the table represent without further context.*

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Principal Display Panel (10 mg Carton)

Arava® Tablets B ONLY are used for medical purposes and contain 10mg of leflunomide. The dosage and administration guidelines can be found in the package insert. It is essential to keep the tablets away from the reach of children and store them at the recommended temperature. The container is oversized for patient convenience, and 30 tablets are present. It is produced by Sanofi company and originated in France. No information is available about "oconizammad0n."*

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Principal Display Panel (20 mg Carton)

This is a description of a medication called Arava. The medication comes in tablet form and is available in doses of either 10 or 20 milligrams. The container has space for 30 or 307 tablets, which is designed to make it easier for patients to use the medication. The medication should be stored at temperatures below 59-86°F and protected from light. The manufacturer is Sanofi, a pharmaceutical company based in France.*

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Principal Display Panel (100 mg Carton)

This text provides instructions for starting Arava therapy, a medication containing leflunomide, for treating rheumatoid arthritis. A dosage initiation pack containing three 100mg tablets is provided for the treatment. The text instructs to take one tablet every day at the same time without skipping a dose. The instructions also suggest that pharmacists will help set a dose and answer any questions regarding the medication. There are some unreadable characters and typos such as "attschd" instead of attached.*

* 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.