Fulvestrant Injection
Product Images NDC 55150-394

Product Visual Gallery

This gallery contains 18 technical images submitted to the FDA as part of the official labeling for Fulvestrant (NDC 55150-394). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Eugia Us Llc, 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

Fulvestrant Figure1 (Fulvestrant Fig1)

An instructional diagram showing the correct method for preparing a Fulvestrant injection. It includes a demonstration of holding a syringe and vial, with labeled parts A, B, and C on the vial's top components, indicating proper assembly or usage steps.*

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Fulvestrant Figure10 (Fulvestrant Fig10)

A line graph depicting overall survival probability (%) over time (months) comparing two treatments: fulvestrant plus palbociclib versus fulvestrant plus placebo. The graph includes a time axis up to 54 months and indicates the number of patients at risk at different time points for each treatment group.*

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Fulvestrant Figure11 (Fulvestrant Fig11)

A Kaplan-Meier survival curve graph depicting survival probability over time (months) for two groups: one receiving Fulvestrant plus Abemaciclib and the other placebo plus Fulvestrant. The graph includes median survival times and patient numbers at risk at various time points for both groups.*

FDA Label Image

Fulvestrant-fig12.jpg (Fulvestrant Fig12)

A Kaplan-Meier survival probability curve comparing two groups: Fulvestrant plus Abemaciclib (N=446) and Fulvestrant plus Placebo (N=223), over a time period of up to 57 months. The graph shows survival probability percentages on the y-axis against time in months on the x-axis, including censored observations indicated by ticks. Patient risk numbers are listed below for both groups at various time points.*

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Fulvestrant-fig13.jpg (Fulvestrant Fig13)

A Kaplan-Meier survival curve showing event-free probability percentage over 26 months comparing Fulvestrant plus Ribociclib versus Fulvestrant plus Placebo. The graph includes censoring times and number of patients at risk at various time points for each treatment group.*

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Fulvestrant-fig14 (Fulvestrant Fig14)

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

FDA Label Image

Package Label.principal Display Panel 250 mg Per 5 mL (50 mg/ml) Syringe Label (Fulvestrant Fig15)

Label for Fulvestrant Injection showing strength of 250 mg/5 mL (50 mg/mL). The label indicates it is for intramuscular use only, provides protection instructions, and instructs that both single-dose prefilled syringes must be used for the 500 mg dose. The label also includes the labeler name, Eugia US LLC, and a barcode with NDC 55150-394-01.*

FDA Label Image

Package Label-principal Display Panel (Peel off Patient Record Label)

Packaging label for Fulvestrant Injection 250 mg/5 mL (50 mg/mL) by Eugia US LLC. The carton states the product is for intramuscular use only, containing two single-dose prefilled syringes totaling 500 mg fulvestrant, with detailed instructions for use and storage requiring refrigeration at 2 to 8°C. The label includes multiple instructional figures on syringe preparation and administration and safety warnings.*

FDA Label Image

Package Label-principal Display Panel (Peel off Patient Record Label)

Label for Fulvestrant Injection 50 mg/mL (250 mg/5 mL) from Eugia US LLC. The label includes fields for date/site, administrator, lot number, and expiration date. The label features the NDC code 55150-394-01 and indicates the product is Rx only for intravenous use.*

FDA Label Image

Fulvestrant Figure2 (Fulvestrant Fig2)

An instructional illustration demonstrating how to prepare an injection. It shows a hand holding a syringe with a needle, drawing liquid from a vial. Additional labeled parts of the vial and cap are highlighted, likely indicating components involved in the preparation process.*

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Fulvestrant Figure3 (Fulvestrant Fig3)

An illustration showing two hands preparing an injection syringe. One hand is holding the syringe barrel while the other is handling the plunger, depicting the process of drawing medication into the syringe.*

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Fulvestrant Figure4 (Fulvestrant Fig4)

An illustration showing a syringe with a needle, including a close-up inset of the needle tip. The image likely depicts components of an intravenous injection device.*

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Fulvestrant Figure5 (Fulvestrant Fig5)

An instructional illustration showing a gloved hand holding a syringe with the thumb pulling back on the plunger. The illustration likely demonstrates how to withdraw medication into the syringe, indicated by the upward arrow near the plunger.*

FDA Label Image

Fulvestrant Figure6 (Fulvestrant Fig6)

A line graph titled 'Progression Free Survival (ITT Population)' showing the proportion of patients progression free over time in months, comparing Fulvestrant 250 mg and Fulvestrant 500 mg. The graph includes survival curves for both dosages and a table below indicating the number of patients at risk at various time points.*

FDA Label Image

Fulvestrant Figure7 (Fulvestrant Fig7)

A Kaplan-Meier survival curve chart depicting the proportion of patients alive over time in months, comparing Fulvestrant 500 mg and Fulvestrant 250 mg groups. The chart includes censored observation tick marks and patient risk numbers at various time points up to 80 months. It notes no statistically significant difference between the groups due to no multiplicity adjustments.*

FDA Label Image

Fulvestrant Figure8 (Fulvestrant Fig8)

A Kaplan-Meier survival curve illustrating the probability of progression-free survival over time in months for two treatment groups: Fulvestrant 500 mg and Anastrozole 1 mg. The chart shows the decrease in survival probability over approximately 36 months, with the number of patients at risk provided below the time axis for both treatments.*

FDA Label Image

Fulvestrant Figure9 (Fulvestrant Fig9)

A Kaplan-Meier survival curve chart depicting progression-free survival probability (%) over time in months for patients treated with fulvestrant combined with palbociclib versus fulvestrant with placebo. The chart includes survival curves and a table showing the number of patients at risk at various time points up to 14 months.*

FDA Label Image

Fulvestrant Structure (Fulvestrant Str)

Chemical structure of Fulvestrant, depicting its molecular framework including hydroxyl groups and fluorinated sulfonyl side chain, corresponding to the active ingredient in Fulvestrant injection 50 mg/mL by Eugia US LLC.*

* 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.