Fulvestrant Injection, Solution
Product Images NDC 63323-715

Product Visual Gallery

This gallery contains 18 technical images submitted to the FDA as part of the official labeling for Fulvestrant (NDC 63323-715). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Fresenius Kabi Usa, 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

Ful04 0006 01

An instructional illustration showing a hand holding a syringe with the thumb and forefinger, while the other hand twists the cap off the syringe. The image demonstrates the step to remove the protective cap from a syringe before administration.*

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Ful04 0006 02

An instructional illustration showing a person holding a syringe with one hand and drawing liquid from a vial held in the other hand, demonstrating the preparation of an injection dose.*

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Ful04 0006 03

An instructional diagram displaying a syringe with a needle attached, including a circular zoomed-in detail highlighting the needle hub connection. The image appears to demonstrate proper assembly or use of the syringe for intramuscular injection.*

FDA Label Image

Ful04 0006 04

An instructional illustration showing a hand holding an injection vial or syringe, with an arrow indicating an upward motion, likely demonstrating how to properly hold or prepare the injection device. No text or additional details about the medication are visible.*

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Ful04 0006 05

Chemical structure of fulvestrant, showing its steroidal backbone with hydroxyl groups and a side chain containing sulfur, oxygen, and fluorinated carbon groups.*

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Ful04 0006 06

A Kaplan-Meier curve chart titled 'Progression Free Survival (ITT Population)' showing the proportion of patients progression free over time (in months) for Fulvestrant 250 mg and 500 mg doses. The chart includes a table below indicating the number of patients at risk at various time points for each dose group.*

FDA Label Image

Ful04 0006 07

A survival curve chart comparing the proportion of patients alive over time (in months) for two dosage groups of Fulvestrant injection, solution at 500 mg and 250 mg. The x-axis represents time in months up to 80 months, and the y-axis represents the proportion of patients alive from 0 to 1. The chart includes risk tables for both dosage groups and notes on censored observations and statistical significance.*

FDA Label Image

Ful04 0006 08

A Kaplan-Meier survival curve chart showing probability of progression-free survival (PFS) over time (months) from randomization. The chart compares two treatment groups: Fulvestrant 500 mg (solid line) and Anastrozole 1 mg (dashed line). A table below the chart lists the number of patients at risk over different time intervals for each treatment group.*

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Ful04 0006 09

A Kaplan-Meier survival curve chart showing progression-free survival probability over time (in months) comparing two groups: palbociclib plus fulvestrant versus placebo plus fulvestrant. The chart includes the number of patients at risk at various time points for both groups and a legend defining FUL as fulvestrant, PAL as palbociclib, and PCB as placebo.*

FDA Label Image

Ful04 0006 10

A line graph showing overall survival probability (%) over time (months) for patients treated with fulvestrant plus palbociclib versus fulvestrant plus placebo. The graph includes survival curves for both treatment groups and a table indicating the number of patients at risk at various time points.*

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Ful04 0006 11

A Kaplan-Meier survival curve depicting progression-free survival probabilities over 30 months. The graph compares two groups: Fulvestrant plus Abemaciclib (solid line) and Fulvestrant plus Placebo (dashed line). Patient numbers at risk for each group are listed below the time axis.*

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Ful04 0006 12

A Kaplan-Meier survival probability curve comparing two groups over time (months): patients treated with Fulvestrant plus Abemaciclib (N=446) and those treated with Fulvestrant plus Placebo (N=223). The chart shows survival probabilities on the y-axis and time in months on the x-axis, with censored observations marked. At the bottom, patient numbers at risk are displayed for each group at different time points.*

FDA Label Image

Ful04 0006 13

A Kaplan-Meier survival curve chart depicting event-free probability (%) over time (months) for two groups: Fulvestrant + Ribociclib (N=484) and Fulvestrant + Placebo (N=242). The chart includes censoring times and number of patients still at risk at various time points up to 26 months.*

FDA Label Image

Ful04 0006 14

A Kaplan-Meier survival curve chart showing event-free probability (%) over time in months for two groups: Fulvestrant + Ribociclib and Fulvestrant + Placebo. The chart includes the number of patients still at risk at various time points and indicates censoring times for the study populations.*

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Ful04 0006 15

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Ful04 0006 16

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Ful04 0006 17

Fulvestrant Injection 250 mg per 5 mL (50 mg per mL) label, for intramuscular use only. The label states the carton contains two pre-filled syringes, each with 250 mg per 5 mL, totaling 500 mg fulvestrant. It includes storage instructions and the labeler name Fresenius Kabi USA, LLC. The product NDC is 63323-715-05.*

FDA Label Image

Ful04 0006 18

Label of Fulvestrant Injection 250 mg per 5 mL (50 mg per mL) in a single-dose pre-filled syringe for intramuscular use. The label states administration instructions, protection from light, and Rx only. Manufactured for Fresenius Kabi USA, LLC, made in Austria, with NDC 63323-715-01.*

* 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.