Fulvestrant Injection, Solution
Product Images NDC 25021-471

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Fulvestrant (NDC 25021-471). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sagent Pharmaceuticals, 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

Figure 1 (Ful0d 0000 01)

An instructional diagram showing the assembly and activation of a syringe with a vial adapter. The steps demonstrate attaching the vial adapter to the vial, aligning and securing it, and preparing the syringe for intramuscular injection of fulvestrant 50 mg/mL injection, solution, labeled by Sagent Pharmaceuticals.*

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Figur 2e (Ful0d 0000 02)

An instructional illustration showing the steps for preparing an injection. It depicts a hand attaching a syringe to a vial or cartridge adapter, demonstrating the technique for drawing medication. Additional close-up views highlight different parts labeled A, B, and C of the vial adapter or syringe assembly.*

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Figure 3 (Ful0d 0000 03)

An instructional illustration showing hands preparing a syringe with medication from a vial. The image depicts one hand holding a vial upside down and the other hand drawing injection solution into the syringe, indicating preparation for intramuscular administration.*

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Figure 4 (Ful0d 0000 04)

An instructional diagram illustrating the assembly or use of an injection device, showing a syringe with a needle and a cap, intended for intramuscular injection of a drug solution, likely fulvestrant based on product data.*

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Figure 5 (Ful0d 0000 05)

An instructional illustration showing a hand wearing a glove preparing a syringe with needle pointing outward. Arrows indicate the motion to pull back the plunger. This likely depicts a step in preparing an intramuscular injection.*

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Structural Formula (Ful0d 0000 06)

Chemical structure of fulvestrant, the active ingredient in the pharmaceutical product. The diagram displays the detailed molecular arrangement including hydroxyl groups and fluorinated side chains, characteristic of fulvestrant's structure.*

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Figure 6 (Ful0d 0000 07)

A line chart titled 'Progression Free Survival (ITT Population)' displaying the proportion of patients progression-free over time in months. It compares two dosages of fulvestrant, 250 mg and 500 mg, with respective curves showing survival trends from 0 to 45 months. Below the chart, a table lists the number of patients at risk at various time points for each dosage group.*

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Figure 7 (Ful0d 0000 08)

A line graph showing the proportion of patients alive over time in months for two doses of fulvestrant: 500 mg and 250 mg. The y-axis represents the proportion of patients alive, ranging from 0 to 1, and the x-axis represents time in months up to 80. Two lines indicate survival trends for 500 mg and 250 mg doses, with accompanying tables below showing numbers at risk over time for each dose. Tick marks on the graph indicate censored observations.*

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Figure 8 (Ful0d 0000 09)

A Kaplan-Meier survival curve depicting the probability of progression-free survival (PFS) over time in months from randomization. The graph compares PFS among patients treated with Fulvestrant, Anastrozole 1 mg, and the combined treatment. The y-axis shows the probability of PFS, while the x-axis shows time in months.*

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Figure 9 (Ful0d 0000 10)

A Kaplan-Meier survival curve chart displaying progression-free survival probability (%) over time in months for two groups: one receiving fulvestrant plus palbociclib, and the other receiving fulvestrant plus placebo. The chart includes patient numbers at risk over several time points.*

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Figure 10 (Ful0d 0000 11)

A Kaplan-Meier survival curve chart depicting overall survival probability (%) over time in months for two groups: fulvestrant plus palbociclib and fulvestrant plus placebo, with a table below showing the number of patients at risk at different time points.*

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Figure 11 (Ful0d 0000 12)

A Kaplan-Meier survival curve showing progression-free survival probability over time in months. The chart compares two groups: patients treated with fulvestrant plus abemaciclib versus patients treated with fulvestrant plus placebo. Censored observations are marked. The graph includes a table indicating the number of patients at risk over time for each treatment group.*

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Figure 12 (Ful0d 0000 13)

A survival probability curve chart comparing two treatment groups: Fulvestrant plus Abemaciclib and Fulvestrant plus Placebo. The x-axis represents time in months, and the y-axis shows survival probability as a percentage. The chart includes lines for censored observations and patient risk numbers at various time points for both groups.*

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Figure 13 (Ful0d 0000 14)

A Kaplan-Meier survival curve chart displaying event-free probability (%) over time in months. The chart compares three groups: Fulvestrant+Ribociclib, Fulvestrant+Placebo, and Censoring Times, with a table below showing the number of patients still at risk at various time points up to 26 months.*

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Figure 14 (Ful0d 0000 15)

A Kaplan-Meier survival curve chart showing event-free probability over time in months. The graph compares two groups: Fulvestrant plus Ribociclib (N=484) and Fulvestrant plus Placebo (N=242). The x-axis represents time in months up to 48 months, and the y-axis shows the percentage of event-free probability from 0 to 100%. The chart includes censored data points and a table indicating the number of patients still at risk at various time points for both groups.*

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Package Label – Principal Display Panel – Syringe Label (Ful0d 0000 16)

Label for Fulvestrant Injection 50 mg/mL by Sagent Pharmaceuticals. The label shows a 250 mg per 5 mL dosage indication. It includes barcodes, spaces to record date/site and administrator details, and warnings for intramuscular use and light protection. The label indicates the product is manufactured for Sagent Pharmaceuticals in Schaumburg, IL, USA, and made in China.*

* 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.