Gliadel Wafer
Product Images NDC 24338-050

11 FDA label images from Azurity Pharmaceuticals, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Gliadel (NDC 24338-050). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Azurity Pharmaceuticals, 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 (Gliadel 01)

Figure 1 (Gliadel 01)
Gliadel carmustine 7.7 mg intracavitary wafer packaging shown beside a gloved individual handling a wafer with forceps in a sterile medical environment. The white box displays the product name, dosage strength, and labeler Azurity Pharmaceuticals.*
FDA Label Image

Figure 2 (Gliadel 02)

FDA Label Image

Figure 3 (Gliadel 03)

Figure 3 (Gliadel 03)
The image shows a person holding a Gliadel wafer, a 7.7 mg intracavitary dosage form containing carmustine. The wafer is being removed from its sterile peel pouch with tweezers. Packaging and instructions are visible in the background. The product is labeled from Azurity Pharmaceuticals, Inc.*
FDA Label Image

Figure 4 (Gliadel 04)

Figure 4 (Gliadel 04)
An illustration showing a gloved hand cutting a Gliadel wafer package open, preparing the carmustine intracavitary wafer for use. The image emphasizes the handling and preparation of the 7.7 mg Gliadel wafer by Azurity Pharmaceuticals, Inc.*
FDA Label Image

Figure 5 (Gliadel 05)

Figure 5 (Gliadel 05)
Gliadel 7.7 mg wafer of carmustine, shown in the image as a small, round, white wafer held by a gloved hand, partially removed from foil packaging. This intracavitary prescription drug is labeled by Azurity Pharmaceuticals, Inc.*
FDA Label Image

Chemical Structure (Gliadel 06)

Chemical Structure (Gliadel 06)
Chemical structure of the random copolymer with a ratio m:n = 20:80, showing linked aromatic and aliphatic segments, typically representing a biodegradable polymer matrix.*
FDA Label Image

Chemical Structure (Gliadel 07)

Chemical Structure (Gliadel 07)
Chemical structure of carmustine, the active ingredient in Gliadel 7.7 mg wafers. The diagram shows the molecular arrangement of atoms comprising carmustine used in intracavitary chemotherapy wafers by Azurity Pharmaceuticals, Inc.*
FDA Label Image

Figure 6 (Gliadel 08)

Figure 6 (Gliadel 08)
A survival curve chart comparing GLIADEL Wafer versus placebo over time in months following implant surgery. The vertical axis represents survival percentage, and the horizontal axis shows months from implant surgery up to 52 months. The GLIADEL Wafer group is represented by a solid line, and the placebo group by a dashed line. A statistical note indicates a log-rank p-value less than 0.05.*
FDA Label Image

Figure 7 (Gliadel 09)

Figure 7 (Gliadel 09)
A survival curve graph showing the percentage survival over six months from implant surgery. It compares Gliadel Wafer with placebo, illustrating higher survival rates for Gliadel Wafer throughout the period. The graph includes a statistical significance indicator with a log-rank p-value of 0.01.*
FDA Label Image

Figure 8 (Gliadel 10)

Figure 8 (Gliadel 10)
A survival rate Kaplan-Meier curve comparing Gliadel (carmustine) wafers with placebo over months from implant surgery. The vertical axis shows survival rate percentage, while the horizontal axis indicates months from surgery up to 54 months. The graph includes statistical test results for Log-Rank and Wilcoxon P values.*
FDA Label Image

Principal Display Panel (8 Wafer Box)

Principal Display Panel (8 Wafer Box)
Gliadel wafer packaging label for carmustine implant, showing strength of 7.7 mg carmustine per wafer. The label indicates each sterile wafer contains 192.3 mg polifeprosan 20 and 7.7 mg carmustine, for intracranial use. The package contains 8 individually packaged wafers, labeled as a cytotoxic agent, with storage instructions at or below -20°C (-4°F). Manufactured by Arbor Pharmaceuticals, 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.