Gleevec Tablet
Product Images NDC 0078-1490

8 FDA label images from Novartis Pharmaceuticals Corporation · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Gleevec (NDC 0078-1490). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Novartis Pharmaceuticals Corporation, 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

Imatinib Structural Formula (Gleevec 01)

Imatinib Structural Formula (Gleevec 01)
Chemical structure diagram of the active ingredient imatinib mesylate, showing the molecular configuration with labeled atoms and bonds as typically depicted in pharmaceutical chemistry representations.*
FDA Label Image

Figure 1 Progression Free Survival (itt Principle) (Gleevec 02)

Figure 1 Progression Free Survival (itt Principle) (Gleevec 02)
A line graph showing percent without progression over 72 months since randomization comparing two treatment arms: Gleevec and IFN-Ara-C. The graph includes patient numbers at various study points and statistical hazard ratio data indicating Gleevec's superior progression-free outcome.*
FDA Label Image

Figure 2 Time To Progression To Ap Or Bc (itt Principle) (Gleevec 03)

Figure 2 Time To Progression To Ap Or Bc (itt Principle) (Gleevec 03)
A Kaplan-Meier curve showing the percentage of patients without progression to acute phase or blast crisis (AP/BC) over time in months since randomization. The chart compares two patient groups: one treated with Gleevec and the other with IFN+A ra-C. The number of patients, hazard ratio with confidence intervals, and statistical significance are noted in the graph.*
FDA Label Image

Figure 3: Study 1 Recurrence-free Survival (itt Population) (Gleevec 04)

Figure 3: Study 1 Recurrence-free Survival (itt Population) (Gleevec 04)
A Kaplan-Meier survival curve chart showing the probability of being alive and recurrence-free over survival time in months. The chart compares two groups: patients taking Imatinib 400 mg and those on placebo, with censored data points indicated for both groups. Patient numbers at risk are listed below the time axis for each group at various time points up to 108 months.*
FDA Label Image

Figure 4: Study 2 Recurrence-free Survival (itt Population) (Gleevec 05)

Figure 4: Study 2 Recurrence-free Survival (itt Population) (Gleevec 05)
A Kaplan-Meier survival curve displaying the probability of recurrence-free survival over a period of up to 84 months. The graph compares two groups treated with imatinib: 12 months and 36 months. The 36-month group shows higher recurrence-free survival rates. The plot includes censored observations and a statistical summary with a hazard ratio and P-value.*
FDA Label Image

Figure 5: Study 2 Overall Survival (itt Population) (Gleevec 06)

Figure 5: Study 2 Overall Survival (itt Population) (Gleevec 06)
A survival curve graph depicting the probability of overall survival over time in months for two groups treated with imatinib for different durations (12 months and 36 months). The graph includes event counts, censored observations, and statistical details such as hazard ratio and p-value.*
FDA Label Image

Principal Display Panel – Package Label – 100 mg Tablets (Gleevec 07)

Principal Display Panel – Package Label – 100 mg Tablets (Gleevec 07)
Label for Gleevec (imatinib mesylate) 100 mg oral tablets by Novartis Pharmaceuticals Corporation. The label specifies each tablet contains 100 mg of imatinib free base. The package contains 90 tablets. It includes the NDC number 0078-0401-34 and states the drug is prescription only.*
FDA Label Image

Principal Display Panel – Package Label – 400 mg Tablets (Gleevec 08)

Principal Display Panel – Package Label – 400 mg Tablets (Gleevec 08)
Gleevec 400 mg tablet packaging label showing imatinib mesylate oral tablets. The label states each tablet contains 400 mg imatinib free base and includes 30 tablets. Manufacturer is Novartis Pharmaceuticals Corporation. The label includes storage instructions, a barcode, and an image of an actual-size 400 mg tablet printed on the label.*

* 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.