Fulvestrant Injection, Solution
Product Images NDC 68001-484

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Fulvestrant (NDC 68001-484). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bluepoint Laboratories, 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

13 (Fulvestrant Injection 1)

An instructional illustration showing proper removal of a cap from a vial using a syringe. The diagram includes labeled parts of the vial cap: A indicates the flip-off top, B the rubber stopper, and C the vial neck. The main image depicts hands gripping the vial and syringe during cap removal.*

FDA Label Image

10 (Fulvestrant Injection 10)

A Kaplan-Meier survival curve chart depicting progression-free survival probability (%) over time in months for two groups: fulvestrant plus palbociclib versus fulvestrant plus placebo. The chart includes patient numbers at risk at various time points, showing higher survival probability for the fulvestrant plus palbociclib group compared to fulvestrant plus placebo up to 14 months.*

FDA Label Image

1 (Fulvestrant Injection 11)

A Kaplan-Meier survival curve graph showing overall survival probability (%) over time in months for two groups: Fulvestrant plus palbociclib (solid line) and Fulvestrant plus placebo (dashed line). The x-axis represents time in months (0 to 54), and the y-axis shows overall survival probability from 0% to 100%. Below the graph, the number of patients at risk for each group is listed at various time points.*

FDA Label Image

Fig 11 (Fulvestrant Injection 12)

A Kaplan-Meier curve showing progression-free survival probability (%) over time (months) for two groups: Fulvestrant plus Abemaciclib (N=446) and Fulvestrant plus Placebo (N=223). The chart includes censored observations and a table displaying patients at risk at various time points for both groups.*

FDA Label Image

Fig 12 (Fulvestrant Injection 13)

A survival probability graph comparing Fulvestrant plus Abemaciclib and Fulvestrant plus Placebo over time in months. The y-axis shows survival probability percentage, and the x-axis shows time in months up to 57 months. The graph includes lines for censored observations and survival probabilities for two patient groups with sample sizes noted. Patient risk numbers at different time points are shown below the x-axis.*

FDA Label Image

Fig 13 (Fulvestrant Injection 14)

A Kaplan-Meier survival curve comparing event-free probability over 26 months between two groups: patients treated with Fulvestrant plus Ribociclib and patients treated with Fulvestrant plus Placebo. The graph includes censoring times, hazard ratio with confidence interval, median event-free times, and a log-rank p-value, accompanied by a table showing the number of patients at risk over time for each group.*

FDA Label Image

1 (Fulvestrant Injection 15)

A Kaplan-Meier survival curve comparing event-free probability (%) over time in months between two groups: Fulvestrant + Ribociclib (N=484) and Fulvestrant + Placebo (N=242). The chart includes censoring times indicated by symbols and a risk table listing the number of patients still at risk at various time points up to 48 months.*

FDA Label Image

Fulvestrant Injection Carton (Fulvestrant Injection 16)

Fulvestrant Injection 250 mg/5 mL (50 mg/mL) solution for intramuscular injection in two single-dose prefilled syringes. The label indicates that the total dose is 500 mg using two syringes of 250 mg/5 mL each. The labeler is BluePoint Laboratories. Packaging includes administration instructions and storage information.*

FDA Label Image

Fulvestrant Injection Syringe Label (Fulvestrant Injection 17)

Label for Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) solution for intramuscular use. The product is manufactured by Amneal Pharmaceuticals Pvt. Ltd. in India for BluePoint Laboratories. The label includes barcodes, NDC 68001-484-86, and instructions noting the requirement of two single-dose prefilled syringes for the 500 mg dose.*

FDA Label Image

14 (Fulvestrant Injection 2)

Illustration showing hands holding a syringe and needle cap, demonstrating removal of the needle cap. Insets A, B, and C label parts of the needle cap assembly, including the protective cover and inner tip.*

FDA Label Image

15 (Fulvestrant Injection 3)

An instructional diagram showing two hands preparing a syringe. One hand holds the syringe barrel while the other hand removes the cap from the needle, illustrating injection preparation steps for an intramuscular solution.*

FDA Label Image

15 (Fulvestrant Injection 4)

An instructional diagram showing a side view of a device with a lever and a magnified circular inset highlighting the tip or edge of a component, likely illustrating a detail for using or assembling the device associated with Fulvestrant injection, solution.*

FDA Label Image

17 (Fulvestrant Injection 5)

An instructional illustration depicting a hand removing the cap from a syringe before administration, indicated by an upward arrow. The drawing emphasizes proper handling of the syringe, relevant for intramuscular injection procedures.*

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16 (Fulvestrant Injection 6)

Chemical structure of Fulvestrant, showing its steroidal backbone and various functional groups including hydroxyl and sulfonyl groups with fluorinated side chains.*

FDA Label Image

66 (Fulvestrant Injection 7)

A line graph 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 y-axis represents the proportion of patients progression free from 0 to 1.0, and the x-axis shows time in months from 0 to 45. Two curves compare the progression-free survival between the two doses. Below the graph, a table lists the number of patients at risk over the study period for each dosage group.*

FDA Label Image

10 (Fulvestrant Injection 8)

A survival curve chart comparing the proportion of patients alive over time (months) for two Fulvestrant dosages, 500 mg and 250 mg. The chart includes tick marks indicating censored observations and patient numbers at risk at various time points. The vertical axis shows the proportion alive, and the horizontal axis shows time in months up to 80.*

FDA Label Image

Fig 8 (Fulvestrant Injection 9)

A Kaplan-Meier survival curve showing the probability of progression-free survival (PFS) over time in months from randomization for two treatments: Fulvestrant 500 mg (solid line) and Anastrozole 1 mg (dashed line). The graph includes the number of patients at risk at various time points for each treatment group.*

* 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.