Sorafenib Tosylate Tablet, Film Coated
Product Images NDC 0378-1201

View Photos of 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 Sorafenib Tosylate (NDC 0378-1201). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mylan 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

Sorafenib Tosylate Structural Formula (9230c4d6 Db85 42be A135 E9e6ef8b9b64 01)

Sorafenib Tosylate Structural Formula (9230c4d6 Db85 42be A135 E9e6ef8b9b64 01)
Chemical structure of Sorafenib Tosylate, showing the detailed molecular arrangement of atoms including chlorine, trifluoromethyl, amide, pyridine, and tosylate groups.*
FDA Label Image

Sorafenib Tablets, Usp 200 mg Bottle Label (Image 01)

Sorafenib Tablets, Usp 200 mg Bottle Label (Image 01)
The label for Sorafenib Tablets, USP, shows a 200 mg oral film-coated tablet. The label includes the NDC 0378-1201-78, with a depiction of a round, pink tablet imprinted with '200'. It is manufactured by Mylan Pharmaceuticals Inc. and Natco Pharma Limited, with a package size of 120 tablets. Storage instructions and dispensing cautions are also present.*
FDA Label Image

Figure 1: Kaplan-meier Curve Of Overall Survival In Hcc Study (intent-to-treat Population) (Image 02)

Figure 1: Kaplan-meier Curve Of Overall Survival In Hcc Study (intent-to-treat Population) (Image 02)
A Kaplan-Meier survival curve comparing the survival probability over months from randomization between Sorafenib tablets (200 mg) and placebo groups. The graph shows higher survival probability for the Sorafenib group with median survival of 10.7 months versus 7.9 months for placebo. Hazard ratio and p-value are included, reflecting statistical analysis.*
FDA Label Image

Figure 2: Kaplan-meier Curves For Progression-free Survival (TARGET (RCC))

Figure 2: Kaplan-meier Curves For Progression-free Survival (TARGET (RCC))
A Kaplan-Meier plot illustrating progression-free survival probability (%) over days from randomization for Sorafenib tablets (n=384) versus placebo (n=385). The chart shows median progression-free survival of 167 days for Sorafenib and 84 days for placebo, with Sorafenib demonstrating higher survival probability throughout the study period.*
FDA Label Image

Figure 3: Kaplan-meier Curve Of Progression-free Survival In Decision (dtc) (Image 04)

Figure 3: Kaplan-meier Curve Of Progression-free Survival In Decision (dtc) (Image 04)
A Kaplan-Meier survival curve comparing progression-free survival duration (in months) between Sorafenib tablets and placebo groups. The y-axis represents the proportion of patients with progression-free survival, and the x-axis shows time in months up to 30. Patient numbers at risk are listed below the graph for both groups at various time points.*

* 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.