Sunitinib Malate Capsule
Product Images NDC 43598-045

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Sunitinib Malate (NDC 43598-045). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Dr.reddys Laboratories 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

Bottle1 (Bottle1)

Label for Sunitinib Malate Capsules 12.5 mg by Dr. Reddy's Laboratories Inc. The label indicates 28 capsules per container, with dosage strength of 12.5 mg sunitinib per capsule. Storage instructions specify 20°C to 25°C with allowed excursions, and capsule contents equate 16.7 mg sunitinib malate. The product is made in India and includes a pharmacist medication guide notice.*

FDA Label Image

Bottle2 (Bottle2)

Sunitinib Malate Capsules 25 mg label showing oral prescription drug packaging with 28 capsules. Label includes storage instructions, dosage note, and barcode. Distributed by Dr. Reddy's Laboratories Inc., made in India. NDC 43598-046-63.*

FDA Label Image

Bottle3 (Bottle3)

Label for Sunitinib Malate Capsules 37.5 mg by Dr. Reddy's Laboratories Inc. The label indicates each capsule contains 50.1 mg sunitinib malate equivalent to 37.5 mg sunitinib. The package contains 28 capsules. Storage instructions specify 20°C to 25°C with allowed excursions. The label includes a barcode and distributor details in Princeton, NJ, with the product made in India.*

FDA Label Image

Bottle4 (Bottle4)

Label for Sunitinib Malate Capsules 50 mg by Dr. Reddy's Laboratories Inc. The label indicates the package contains 28 capsules. It includes storage instructions, dosage remarks, and a barcode. The label highlights that each capsule contains sunitinib malate equivalent to 50 mg sunitinib, and the product is labeled for prescription use only.*

FDA Label Image

Figure1 (Figure1)

A Kaplan-Meier curve showing time to tumor progression probability over weeks comparing Sunitinib Malate and placebo groups. The graph plots progression-free survival with Sunitinib Malate (N=207) and placebo (N=105), including median survival times and hazard ratio with confidence intervals.*

FDA Label Image

Figure2 (Figure2)

A Kaplan-Meier survival curve chart depicting progression free survival probability (%) over time in weeks for Sunitinib malate and IFN-α in a study with 375 subjects per group. The Sunitinib malate group shows higher survival probability over time compared to IFN-α, with a median of 47.3 weeks versus 22.0 weeks. The chart includes a hazard ratio of 0.42 with a 95% confidence interval of 0.32 to 0.54 and a p-value less than 0.000001.*

FDA Label Image

Figure3 (Figure3)

A Kaplan-Meier curve showing disease-free survival probability (%) over time in years comparing Sunitinib Malate (N=309) versus placebo (N=306). The solid line represents Sunitinib Malate with a median survival of 6.8 years, and the dotted line represents placebo with a median survival of 5.6 years. A hazard ratio of 0.76 with 95% confidence interval (0.59, 0.98) and p-value of 0.03 is noted. The number of subjects at risk is displayed below the time axis for both groups.*

FDA Label Image

Figure4 (Figure4)

A Kaplan-Meier survival curve showing progression-free survival probability over time in months for two groups: Sunitinib Malate (N=86) and placebo (N=85). The graph indicates a higher median progression-free survival for the Sunitinib Malate group at 10.2 months compared to 5.4 months for the placebo group. Additional statistics on hazard ratio, confidence interval, and p-value are included.*

FDA Label Image

Structure (Structure)

Chemical structure of Sunitinib Malate, showing its molecular framework including aromatic rings, amide, fluorine atom, and carboxylic acid groups.*

* 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.