Fulvestrant Injection, Solution
Product Images NDC 70121-1463

Product Visual Gallery

This gallery contains 19 technical images submitted to the FDA as part of the official labeling for Fulvestrant (NDC 70121-1463). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amneal Pharmaceuticals 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

1 (Fulvestrant Injection Pprx 1)

An instructional illustration showing the removal of a cap from a syringe vial. The left side shows hands holding a syringe and vial cap with a crossed-out needle symbol, indicating no needle is used for this step. The right side depicts labeled parts of the vial cap: A is the top seal, B is the stopper, and C is the vial neck collar.*

FDA Label Image

9 (Fulvestrant Injection Pprx 10)

A Kaplan-Meier survival curve chart depicting progression-free survival probability (%) over time in months for two groups: fulvestrant plus palbociclib and fulvestrant plus placebo. The chart includes a risk table showing the number of patients at risk at various time points for both groups, with the fulvestrant plus palbociclib group consistently having higher survival probabilities compared to the fulvestrant plus placebo group.*

FDA Label Image

10 (Fulvestrant Injection Pprx 11)

A Kaplan-Meier survival curve chart comparing overall survival probability (%) over time (months) between two groups: patients treated with Fulvestrant plus palbociclib and patients treated with Fulvestrant plus placebo. The chart includes a tabulation of patient numbers at risk over time and clarifies abbreviations for Fulvestrant (FUL), palbociclib (PAL), and placebo (PCB).*

FDA Label Image

11 (Fulvestrant Injection Pprx 12)

A Kaplan-Meier survival curve chart comparing progression-free survival probabilities over time (in months) between two patient groups: Fulvestrant plus Abemaciclib and Fulvestrant plus Placebo. The chart shows survival percentages on the y-axis and months on the x-axis, with censored observations marked. Patient risk numbers are listed below the graph for both groups at various time points up to 30 months.*

FDA Label Image

12 (Fulvestrant Injection Pprx 13)

A Kaplan-Meier survival curve graph showing survival probability (%) versus time in months for two groups: patients treated with Fulvestrant plus Abemaciclib (N=446) and Fulvestrant plus Placebo (N=223). The graph includes censored observations and a table listing patients at risk over time for each group.*

FDA Label Image

13 (Fulvestrant Injection Pprx 14)

A Kaplan-Meier survival curve chart comparing event-free probability percentages over 26 months for two groups: Fulvestrant plus Ribociclib and Fulvestrant plus Placebo. The x-axis represents time in months, and the y-axis shows event-free probability percentage, with patient counts at risk listed below the time axis.*

FDA Label Image

14 (Fulvestrant Injection Pprx 15)

A Kaplan-Meier survival curve chart depicting event-free probability (%) over time in months for three groups: Fulvestrant+Ribociclib, Fulvestrant+Placebo, and Censoring Times. The x-axis represents time in months up to 42 months, and the y-axis shows event-free probability from 0% to 100%. Patient numbers at risk are displayed in a table below the x-axis for each treatment group at specified time points.*

FDA Label Image

2 (Fulvestrant Injection Pprx 16)

FDA Label Image

3 (Fulvestrant Injection Pprx 17)

FDA Label Image

3 (Fulvestrant Injection Pprx 18)

Label for Fulvestrant Injection 250 mg/5 mL (50 mg/mL) solution for intramuscular injection by Amneal Pharmaceuticals LLC. The label shows the product name, strength, manufacturer details, barcode, lot and expiration date fields, and usage instructions indicating protection from light and dosing information. The label includes a transparent strip and mentions the product is made in India.*

FDA Label Image

4 (Fulvestrant Injection Pprx 19)

Fulvestrant Injection 250 mg/5 mL (50 mg/mL) carton label from Amneal Pharmaceuticals LLC. The packaging contains 2 single-dose prefilled syringes with instructions for intramuscular use. Storage directions specify refrigeration at 2° to 8°C and protection from light. The label includes dosage warnings, detailed syringe assembly and administration steps, and images illustrating usage. The label also displays the NDC 70121-1463 and the PremierProRx logo.*

FDA Label Image

2 (Fulvestrant Injection Pprx 2)

An instructional illustration showing how to prepare a syringe for injection. The left side depicts a hand pulling the plunger of a syringe, while the right side labels parts of a vial or syringe assembly as A, B, and C components.*

FDA Label Image

3 (Fulvestrant Injection Pprx 3)

An instructional diagram showing two hands preparing a syringe by attaching a needle or removing a cap. The illustration suggests steps for preparing an intramuscular injection, consistent with medication administration procedures.*

FDA Label Image

4 (Fulvestrant Injection Pprx 4)

An illustration showing a medical injection device fitted with a needle. A magnified detail highlights the needle tip, emphasizing its design or structure. The device appears to be designed for intramuscular injection, consistent with the Fulvestrant injection, solution packaging.*

FDA Label Image

5 (Fulvestrant Injection Pprx 5)

An instructional illustration showing a gloved hand holding a syringe with a needle cap being removed by pulling it straight off in the direction indicated by an arrow.*

FDA Label Image

1 (Fulvestrant Injection Pprx 6)

Chemical structure diagram of Fulvestrant, showing its molecular framework with hydroxyl groups and fluorinated side chains as part of the active ingredient's molecular composition.*

FDA Label Image

6 (Fulvestrant Injection Pprx 7)

A Kaplan-Meier survival curve graph titled 'Progression Free Survival (ITT Population)' comparing Fulvestrant 250 mg and 500 mg. The x-axis represents Time in Months (0 to 45), and the y-axis shows the Proportion of Patients Progression Free (0 to 1.0). It includes a table beneath indicating the number of patients at risk over time for each dosage group.*

FDA Label Image

7 (Fulvestrant Injection Pprx 8)

A Kaplan-Meier survival curve showing the proportion of patients alive over time (months) comparing Fulvestrant 500 mg and Fulvestrant 250 mg. The graph includes censored observation tick marks and a risk table with patient counts at different time points for each dose group.*

FDA Label Image

8 (Fulvestrant Injection Pprx 9)

A Kaplan-Meier survival curve comparing the probability of progression-free survival over time (months) between two treatments: Fulvestrant 500 mg and Anastrozole 1 mg. The chart shows stepwise declines in survival probability with corresponding data points over approximately 33 months.*

* 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.