Sunitinib Malate Capsule
Product Images NDC 0378-6678

9 FDA label images from Mylan Pharmaceuticals Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Sunitinib Malate (NDC 0378-6678). 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.

Product Images & Figures Index

FDA Label Image

Sunitinib Structural Formula (Image 01)

Sunitinib Structural Formula (Image 01)
Chemical structure of sunitinib malate, showing its molecular components and bonding arrangement as depicted in the image.*
FDA Label Image

Figure 1. Kaplan-meier Curve Of Ttp In Gist Study 1 (intent-to-treat Population) (Image 02)

Figure 1. Kaplan-meier Curve Of Ttp In Gist Study 1 (intent-to-treat Population) (Image 02)
A Kaplan-Meier curve illustrating time to tumor progression probability over weeks, comparing Sunitinib (N=207) versus placebo (N=105). The graph shows higher progression-free probability over time for Sunitinib with a median of 27.3 weeks compared to 6.4 weeks for placebo. Hazard ratio and confidence interval values are also displayed.*
FDA Label Image

Figure 2. Kaplan-meier Curve Of Pfs In Treatment-naïve Rcc Study 3 (intent-to-treat Population) (Image 03)

Figure 2. Kaplan-meier Curve Of Pfs In Treatment-naïve Rcc Study 3 (intent-to-treat Population) (Image 03)
Kaplan-Meier plot showing progression free survival probability (%) over time in weeks for two treatment groups: Sunitinib (N=375) and IFN-α (N=375). The plot includes median survival weeks for each group and a hazard ratio with confidence interval and p-value, illustrating comparative survival outcomes over 60 weeks.*
FDA Label Image

Figure 3. Kaplan-meier Curve Of Disease-free Survival As Assessed By Bicr (intent-to-treat Population) (Image 04)

Figure 3. Kaplan-meier Curve Of Disease-free Survival As Assessed By Bicr (intent-to-treat Population) (Image 04)
A Kaplan-Meier survival curve chart comparing disease-free survival probability over time in years between patients treated with Sunitinib (n=309) and placebo (n=306). The chart shows Sunitinib with a higher median survival of 6.8 years compared to placebo at 5.6 years, including hazard ratio and confidence interval details.*
FDA Label Image

Figure 4. Kaplan-meier Curve Of Pfs In The Pnet Study 6 (Image 05)

Figure 4. Kaplan-meier Curve Of Pfs In The Pnet Study 6 (Image 05)
A Kaplan-Meier survival curve chart comparing progression-free survival probability (%) over time in months between patients treated with Sunitinib (N=86) and placebo (N=85). The chart includes median progression-free survival times, hazard ratio, confidence interval, p-value, and number of subjects at risk at various time points for each group.*
FDA Label Image

Sunitinib Malate Capsules 12.5 mg Bottle Label (Image 06)

Sunitinib Malate Capsules 12.5 mg Bottle Label (Image 06)
Sunitinib Malate 12.5 mg capsules label from Mylan Pharmaceuticals Inc. The label includes the drug name prominently, strength (12.5 mg), form (capsules), and package count (28 capsules). It has dispensing instructions, storage conditions, and usage warnings. The label features the Mylan logo and an NDC barcode with code 0378-6678-28.*
FDA Label Image

Sunitinib Malate Capsules 25 mg Bottle Label (Image 07)

Sunitinib Malate Capsules 25 mg Bottle Label (Image 07)
Sunitinib Malate 25 mg oral capsules, manufactured by Mylan Pharmaceuticals Inc. The label shows the product strength of 25 mg per capsule, with a package containing 28 capsules. Instructions to dispense the accompanying Medication Guide and storage conditions are provided. The label includes a barcode and a note indicating that each capsule contains 25 mg sunitinib equivalent to 33.4 mg sunitinib malate.*
FDA Label Image

Sunitinib Malate Capsules 37.5 mg Bottle Label (Image 08)

Sunitinib Malate Capsules 37.5 mg Bottle Label (Image 08)
Sunitinib Malate 37.5 mg capsules packaging label by Mylan Pharmaceuticals Inc. Contains 28 capsules with prescription-only status. Label includes dosage strength, lot and expiration serialization area, handling instructions, storage conditions, and dispensing directions. Manufactured in Puerto Rico.*
FDA Label Image

Sunitinib Malate Capsules 50 mg Bottle Label (Image 09)

Sunitinib Malate Capsules 50 mg Bottle Label (Image 09)
Sunitinib Malate 50 mg capsules packaging label from Mylan Pharmaceuticals Inc., containing 28 capsules. The label includes dosing strength, barcode, NDC 0378-6680-28, storage instructions, and a note for pharmacists to dispense the accompanying Medication Guide to patients. The label also states the product is Rx only.*

* 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.