Sotylize Solution
Product Images NDC 24338-530

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

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Sotylize (NDC 24338-530). 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 (Sotalol 01)

Figure 1 (Sotalol 01)
A line graph illustrating the age factor relative to age in months. The x-axis represents age in months on a logarithmic scale from 0.1 to 50, while the y-axis shows the age factor ranging from 0 to 1. The graph demonstrates an increasing age factor with age, reaching 1.0 at 24 months and remaining constant thereafter.*
FDA Label Image

Chemical Structure (Sotalol 02)

Chemical Structure (Sotalol 02)
Chemical structure of sotalol hydrochloride, the active ingredient in SOTYLIZE oral solution. The diagram depicts the molecular formula with labeled functional groups as shown in the image.*
FDA Label Image

Figure 2 (Sotalol 03)

Figure 2 (Sotalol 03)
A Kaplan-Meier curve showing recurrence-free survival over time (days) comparing oral Sotalol at doses of 80 mg, 120 mg, and 160 mg against placebo. The graph includes P-values from a log-rank test for each dose level versus placebo, indicating statistical comparisons of survival rates across approximately 360 days.*
FDA Label Image

Figure 3 (Sotalol 04)

Figure 3 (Sotalol 04)
A Kaplan-Meier survival plot showing recurrence-free survival over time (days) comparing Oral Sotalol versus Placebo. The chart includes two survival curves labeled BETAPACE AF and Placebo, with the BETAPACE AF group demonstrating higher recurrence-free survival rates. The log-rank test p-value is 0.002, indicating statistical significance.*
FDA Label Image

Principal Display Panel (250 mL Bottle Label)

Principal Display Panel (250 mL Bottle Label)
Label for Sotylize (sotalol hydrochloride) oral solution 5 mg/mL, 250 mL bottle. The label states this is for oral use only, provided by Azurity Pharmaceuticals, Inc., and distributed by Arbor Pharmaceuticals, LLC, Atlanta, GA. It includes storage instructions, inactive ingredients, and a barcode.*

* 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.