Leflunomide Tablet, Film Coated
Product Images NDC 35573-448

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Leflunomide (NDC 35573-448). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Burel Pharmaceuticals, 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 (Leflunomide Tablets 1)

Chemical structure of leflunomide, showing its molecular framework including a substituted isoxazole ring and a trifluoromethylphenyl group.*

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Chemical Structure (Leflunomide Tablets 2)

Chemical structure of teriflunomide, a related compound to leflunomide, showing rings and functional groups including trifluoromethyl, amide, ketone, and nitrile moieties. The structure includes annotations and the code A77 1726 (teriflunomide).*

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Figure 1 (Leflunomide Tablets 3)

A bar graph titled '% ACR 20 Responder at Endpoint' displaying response rates in three clinical trials at 6 or 12 months. The graph compares Leflunomide (L), Methotrexate (M), Placebo (P), and Sulfasalazine (S) across trials, showing percentage responders ranging approximately from 18.6% to 56.6%. Trial 1 and Trial 3 last 12 months; Trial 2 lasts 6 months.*

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Figure 2 (Leflunomide Tablets 4)

A line graph titled 'Trial 1 ACR Responders Over Time' plotting the percentage of responders on the vertical axis against months on the horizontal axis over a 12-month period. The graph compares three groups labeled PL, MTX, and LEF, showing response trends over time with LEF having the highest responder percentage at most time points.*

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Figure 3 (Leflunomide Tablets 5)

A bar chart titled 'Change in Sharp Score' depicting progression over three trials with durations of 12 months, 6 months, and 12 months. The chart compares Leflunomide, methotrexate, sulfasalazine, and placebo across these trials, showing numeric values representing change in scores for each treatment group.*

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Figure 4 (Leflunomide Tablets 6)

A bar chart titled "Change in Functional Ability Measure" showing improvement scores measured by the HAQ Disability Index over three clinical trials. The chart compares three treatments: Leflunomide (L), Methotrexate (M), Placebo (P), and Sulfasalazine (S) at different time points (6 and 12 months). The vertical axis indicates improvement with values ranging from 0 to -0.6, with bars for each treatment labeled with respective numerical values.*

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Pdp (Leflunomide Tablets 7)

Packaging label for Leflunomide Tablets, USP 10 mg by Burel Pharmaceuticals, LLC. The label indicates the product contains 30 film-coated tablets for oral use. The box includes warnings, storage instructions, manufacturer details (Haupl Pharma Munster GmbH, Germany), and states Rx only. The label displays the NDC 35573-447-30 and features the Burel Pharma logo.*

FDA Label Image

Pdp (Leflunomide Tablets 8)

Leflunomide Tablets, USP 20 mg film-coated tablets packaging label from Burel Pharmaceuticals, LLC. The carton contains 30 tablets for oral use with clear markings of the dosage strength, quantity, and manufacturer details. The label includes warnings, storage instructions, and barcode for an NDC code 35573-448-30.*

* 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.