Sorafenib Tosylate Structural Formula (9230c4d6 Db85 42be A135 E9e6ef8b9b64 01)
Sorafenib Tosylate Tablet, Film Coated
Product Images NDC 0378-1201
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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.
Sorafenib Tablets, Usp 200 mg Bottle Label (Image 01)
This is a description of Sorafenib tablets, which are film-coated and contain 200 mg of sorafenib. They are stored in a dry place at a temperature of 20°C to 25°C (68°F to 77°F) and should be kept in a tight, light-resistant container with a child-resistant closure. It is important to keep this and all medications out of reach of children. The usual dosage for Sorafenib is indicated in the prescribing information. The tablets are manufactured by Natco Ph: Limited in India and distributed by Mylan Pharmaceuticals Inc. in the United States.*
Figure 1: Kaplan-meier Curve Of Overall Survival In Hcc Study (intent-to-treat Population) (Image 02)
This is a clinical trial result showing the effectiveness of Sorafenib tablets compared to Placebo. The trial involved 299 patients who received Sorafenib tablets and 303 patients who received Placebo. The median survival period for patients who received Sorafenib was 10.7 months, while that of patients who received Placebo was 7.9 months. The Hazard Ratio (HR) for Sorafenib tablets was 0.69 with a p-value of 0.00058, indicating that Sorafenib tablets increased patient survival significantly. The graph shows the number of patients at risk over time, with Sorafenib tablets showing a higher number of patients at risk for a longer duration compared to Placebo.*
Figure 2: Kaplan-meier Curves For Progression-free Survival (TARGET (RCC))
The text describes the progression-free survival probability in a clinical trial of sorafenib tablets versus placebo. The trial included 754 participants, with 384 receiving sorafenib tablets and 385 receiving placebo. The median progression-free survival for sorafenib was 167 days compared to 84 days for placebo. The hazard ratio was 0.44 and the p-value was less than 0.000001, indicating a significant difference in progression-free survival between the two groups. The graph shows the number of days from randomization on the x-axis and the probability of progression-free survival on the y-axis.*
Figure 3: Kaplan-meier Curve Of Progression-free Survival In Decision (dtc) (Image 04)
This is a summary of a clinical trial comparing the efficacy of Sorafenib tablets versus Placebo. The text includes the numbers and percentages of patients in each group and their status over time. The duration of progression-free survival is also shown graphically. There is not enough contextual information to provide a detailed account of the trial or its results.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
