Simponi Aria Solution
Product Images NDC 57894-350

4 FDA label images from Janssen Biotech, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 4 technical images submitted to the FDA as part of the official labeling for Simponi Aria (NDC 57894-350). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Janssen Biotech, 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

Figure 1 (Simponi 01)

Figure 1 (Simponi 01)
A line graph depicting the percentage of ACR 20 responders over 24 weeks. It compares SIMPONI ARIA 2 mg/kg plus MTX (methotrexate) versus placebo plus MTX, showing a higher responder rate with SIMPONI ARIA throughout the study period.*
FDA Label Image

Figure 2 (Simponi 01a)

Figure 2 (Simponi 01a)
A line graph comparing the percent of ACR 20 responders over 24 weeks between SIMPONI ARIA 2 mg/kg and placebo. The x-axis represents time in weeks and the y-axis represents the percent of responders. The SIMPONI ARIA group shows a greater and more rapid increase in response rate compared to the placebo group.*
FDA Label Image

Figure 3 (Simponi 01b)

Figure 3 (Simponi 01b)
A line chart comparing the percent of ACR20 responders over time (weeks) between placebo and SIMPONI ARIA 2 mg/kg groups. The horizontal axis shows time in weeks up to 16 weeks, and the vertical axis shows the percent of responders. The SIMPONI ARIA group shows a steadily increasing response rate, while the placebo group remains relatively low and flat throughout.*
FDA Label Image

Aria Pdp (Simponi Aria)

Aria Pdp (Simponi Aria)
Packaging label for SIMPONI ARIA (golimumab) 50 mg/4 mL (12.5 mg/mL) solution for intravenous infusion. The label indicates it is a single-dose vial, intended for intravenous use, with storage instructions and dosage details. The labeler is Janssen Biotech, Inc., and the package includes barcodes, product NDC 57894-350, and Johnson & Johnson branding.*

* 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.