Bortezomib Injection, Powder, Lyophilized, For Solution
Product Images NDC 60505-6050

14 FDA label images from Apotex Corp · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Bortezomib (NDC 60505-6050). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Apotex Corp, 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

Figure6 (Figure6)

Figure6 (Figure6)
A Kaplan-Meier survival curve comparing the percentage of subjects alive over months from randomization for two groups: VcR-CAP (solid line) and R-CHOP (dashed line). The graph includes a hazard ratio of 0.66 (95% CI: 0.51, 0.85) and shows the number of subjects at risk at various time points for each group.*
FDA Label Image

Chemical-structure (Bortezomib 01)

Chemical-structure (Bortezomib 01)
Chemical structure of bortezomib, showing its molecular framework with a boronic acid moiety and peptide-like backbone, as depicted in the diagram.*
FDA Label Image

Bortezomib-for-injection-3.5mg-vial-label (Bortezomib 02)

Bortezomib-for-injection-3.5mg-vial-label (Bortezomib 02)
Label for Bortezomib Injection 3.5 mg/vial by Apotex Corp. This lyophilized powder for injection is indicated for intravenous or subcutaneous use. The single dose vial contains bortezomib and mannitol. The label includes storage instructions, a barcode, and spaces for lot number and expiration date.*
FDA Label Image

Bortezomib-for-injection-3.5mg-vial-carton-label (Bortezomib 03)

Bortezomib-for-injection-3.5mg-vial-carton-label (Bortezomib 03)
Label for Bortezomib for Injection 3.5 mg/vial, lyophilized powder for solution by Apotex Corp. The carton includes details on drug contents, reconstitution instructions for both subcutaneous and intravenous use, storage conditions, and manufacturing information from Gland Pharma Limited, India. The label features the NDC 60505-6050-4 and dosage route indications for intravenous or subcutaneous use.*
FDA Label Image

Figure 1 (Bortezomib 04)

Figure 1 (Bortezomib 04)
A survival curve chart comparing percentage of patients over time in months for two treatments: Bortezomib-MP and MP. The chart shows greater patient survival for Bortezomib-MP, with a p-value of 0.000002 indicating statistical significance. Numerical patient counts at risk are provided below the time axis for each treatment group at multiple time points up to 24 months.*
FDA Label Image

Figure 2 (Bortezomib 05)

Figure 2 (Bortezomib 05)
A survival curve chart comparing two patient groups: Bortezomib-MP and MP, showing percentage of patients over time in months. The Bortezomib-MP group shows higher survival percentages than the MP group across the timeline of up to 78 months. The chart includes numbers of patients at risk under each timepoint and notes a p-value less than 0.05 for statistical significance from a log-rank test.*
FDA Label Image

Figure 3 (Bortezomib 06)

Figure 3 (Bortezomib 06)
A survival curve chart comparing the proportion of patients over time (days) for treatments Bortezomib and Dexamethasone. The vertical axis shows the proportion of patients, and the horizontal axis shows time in days up to 480. The chart includes patient counts remaining at specific time points and a p-value from a log-rank test.*
FDA Label Image

Figure 4 (Bortezomib 07)

Figure 4 (Bortezomib 07)
A survival curve chart comparing the proportion of patients over time (days) between two treatments: Bortezomib and Dexamethasone. The y-axis shows the proportion of patients from 0 to 1, and the x-axis shows time in days up to 450. Bortezomib (blue line with circles) demonstrates a higher survival proportion than Dexamethasone (red line with crosses). Patient counts remaining at various time points are also noted.*
FDA Label Image

Bortezomib-for-injection-3.5mg-vial-flipped-carton-label (Bortezomib Flipped Carton Label)

Bortezomib-for-injection-3.5mg-vial-flipped-carton-label (Bortezomib Flipped Carton Label)
Unfolded carton label for BORTEZOMIB injection, powder, lyophilized, for solution, 3.5 mg strength by Apotex Corp. The label includes a section with reconstitution information for subcutaneous and intravenous injections, specifying amounts of 0.9% sodium chloride to add and target concentrations. No other visible branding or dosage details appear on the label portion shown.*
FDA Label Image

Figure5 (Figure5)

Figure5 (Figure5)
A Kaplan-Meier survival curve comparing two treatment groups, VcR-CAP and R-CHOP, over time in months. The y-axis shows the percentage of patients surviving. The VcR-CAP group demonstrates higher survival percentages compared to the R-CHOP group. A log-rank test p-value is noted as <0.001. The graph includes the number of subjects at risk for each group at various time points.*
FDA Label Image

Intravenous-dose (Intravenous Dose)

Intravenous-dose (Intravenous Dose)
Text describing the calculation for Bortezomib injection dose, showing the formula to determine the total bortezomib dose based on patient body surface area (BSA) in square meters, concentration of 1 mg/mL, and injection volume administered in milliliters.*
FDA Label Image

Bortezomib-for-injection-3.5mg-vial-sticker-label (Sticker Label)

Bortezomib-for-injection-3.5mg-vial-sticker-label (Sticker Label)
Label for Bortezomib for Injection showing separate instructions for subcutaneous injection (1.4 mL 0.9% Sodium Chloride to make 2.5 mg/mL concentration) and intravenous injection (3.5 mL 0.9% Sodium Chloride to make 1 mg/mL concentration). Directions include placing stickers on vials and syringes accordingly. The label emphasizes route-specific preparation for Bortezomib injection made by Apotex Corp.*
FDA Label Image

Subcutaneous-dose (Subcutaneous Dose)

Subcutaneous-dose (Subcutaneous Dose)
A formula expression calculating the total bortezomib dose for injection based on patient body surface area (BSA) in square meters and a concentration of 2.5 mg/mL, resulting in the total bortezomib injection volume in milliliters administered.*
FDA Label Image

Bortezomib-for-injection-3.5mg-vial-tyvek Tray-lid-label (Tray Lid Label)

Bortezomib-for-injection-3.5mg-vial-tyvek Tray-lid-label (Tray Lid Label)
Label for Bortezomib for Injection, 3.5 mg/vial, a lyophilized powder for solution injection. The label includes warnings to read reconstitution information and protect from light. It specifies single-dose vial use, discarding unused portion, and administration via intravenous or subcutaneous routes. The label displays the NDC 60505-6050-4 and is labeled by Apotex Corp.*

* 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.