Fulvestrant Injection
Product Images NDC 71288-555

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 18 technical images submitted to the FDA as part of the official labeling for Fulvestrant (NDC 71288-555). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Meitheal Pharmaceuticals Inc, 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 (Ful08 0004 01)

Figure 1 (Ful08 0004 01)
Instructional diagram showing how to twist off the cap of a Fulvestrant injection vial. The first part illustrates a hand twisting the cap counter-clockwise on a syringe, and the second part labels parts A, B, and C on the vial cap, emphasizing twisting the cap counter-clockwise until it disconnects for removal.*
FDA Label Image

Figure 2 (Ful08 0004 02)

Figure 2 (Ful08 0004 02)
An instructional diagram showing how to attach a needle to a syringe. The image includes a close-up of the syringe tip labeled with parts A, B, and C, indicating distinct components for needle attachment. The hands demonstrate the twisting motion to secure the needle onto the syringe.*
FDA Label Image

Figure 3 (Ful08 0004 03)

Figure 3 (Ful08 0004 03)
An instructional illustration showing hands drawing liquid from a vial into a syringe, demonstrating preparation of an intramuscular injection, relevant to the Fulvestrant 50 mg/mL injection product by Meitheal Pharmaceuticals Inc.*
FDA Label Image

Figure 4 (Ful08 0004 04)

Figure 4 (Ful08 0004 04)
An instructional illustration showing the use of a syringe with a needle cover being removed. The image likely demonstrates preparation steps for an intramuscular injection, relevant to Fulvestrant 50 mg/mL injection by Meitheal Pharmaceuticals Inc.*
FDA Label Image

Figure 5 (Ful08 0004 05)

Figure 5 (Ful08 0004 05)
An instructional diagram showing a hand holding an injection vial or ampule with the thumb pushing upward on the vial top, illustrating preparation or opening of an intramuscular injection device for Fulvestrant.*
FDA Label Image

Structural Formula (Ful08 0004 06)

Structural Formula (Ful08 0004 06)
Chemical structure of Fulvestrant, showing its complex molecular configuration including hydroxyl groups and a sulfonyl side chain.*
FDA Label Image

Figure 6 (Ful08 0004 07)

Figure 6 (Ful08 0004 07)
A progression-free survival curve chart showing the proportion of patients progression free over time in months for Fulvestrant 250 mg and 500 mg in the ITT population. The graph includes the number of patients at risk at various time points for each dosage group.*
FDA Label Image

Figure 7 (Ful08 0004 08)

Figure 7 (Ful08 0004 08)
A survival curve chart showing the proportion of patients alive over time in months for Fulvestrant Injection at doses of 250 mg and 500 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 curves with tick marks indicating censored observations compare the survival between the two dosage groups, with accompanying patient risk numbers at various time points.*
FDA Label Image

Figure 8 (Ful08 0004 09)

Figure 8 (Ful08 0004 09)
A Kaplan-Meier survival curve showing the probability of progression-free survival (PFS) over time in months. The graph compares two treatments: Fulvestrant Injection 500 mg and Anastrozole 1 mg, with the number of patients at risk listed below the x-axis for each time point. The y-axis represents the probability of PFS, ranging from 0.0 to 1.0.*
FDA Label Image

Figure 9 (Ful08 0004 10)

Figure 9 (Ful08 0004 10)
A Kaplan-Meier survival curve chart comparing progression-free survival probability (%) over time (months) for two groups: Fulvestrant Injection combined with palbociclib and Fulvestrant Injection with placebo. The chart includes patient risk counts at various time points below the graph, illustrating the survival distribution over approximately 14 months for both treatment arms.*
FDA Label Image

Figure 10 (Ful08 0004 11)

Figure 10 (Ful08 0004 11)
A Kaplan-Meier survival curve showing overall survival probability (%) over time in months for patients receiving Fulvestrant Injection in combination with either palbociclib or placebo. The solid line represents Fulvestrant plus palbociclib and the dashed line represents Fulvestrant plus placebo. Below the x-axis, the number of patients at risk is listed for both groups at various time points.*
FDA Label Image

Figure 11 (Ful08 0004 12)

Figure 11 (Ful08 0004 12)
A Kaplan-Meier survival curve chart showing progression-free survival probability (%) over time in months for two groups: Fulvestrant Injection plus Abemaciclib (N=446) and Fulvestrant Injection plus Placebo (N=223). The chart includes censored observations and a patients-at-risk table beneath the x-axis.*
FDA Label Image

Figure 12 (Ful08 0004 13)

Figure 12 (Ful08 0004 13)
This is a survival probability chart depicting the percentage survival over time in months for patients receiving Fulvestrant Injection with either Abemaciclib or Placebo. The chart includes censored observation markers and survival curves for both treatment groups, with a table showing numbers of patients at risk over the study period.*
FDA Label Image

Figure 13 (Ful08 0004 14)

Figure 13 (Ful08 0004 14)
A Kaplan-Meier survival curve chart comparing event-free probability over time (in months) for patients receiving Fulvestrant Injection with Ribociclib (N=484) versus Fulvestrant Injection with Placebo (N=242). The x-axis represents time in months, and the y-axis represents event-free probability percentage. Data points include patient counts at various time intervals.*
FDA Label Image

Figure 14 (Ful08 0004 15)

Figure 14 (Ful08 0004 15)
A Kaplan-Meier survival curve graph depicting event-free probability (%) over time in months. The plot compares three groups: Fulvestrant Injection with Ribociclib, Fulvestrant Injection with Placebo, and censoring times, with the number of patients still at risk listed below the x-axis across the study duration up to 48 months.*
FDA Label Image

Meitheal Logo (Ful08 0004 16)

FDA Label Image

Principal Display Panel – Fulvestrant Injection, 250 mg Per 5 mL (50mg Per mL) Syringe Label (Ful08 0004 17)

Principal Display Panel – Fulvestrant Injection, 250 mg Per 5 mL (50mg Per mL) Syringe Label (Ful08 0004 17)
Label for Fulvestrant Injection 250 mg per 5 mL (50 mg per mL) by Meitheal Pharmaceuticals Inc. The label indicates the product is for intramuscular use only and includes spaces for date, site, and administrator. It also includes handling instructions to protect from light and a note about dosage requirements. Barcodes and the NDC 71288-555 are visible.*
FDA Label Image

Principal Display Panel – Fulvestrant Injection, 250 mg Per 5 mL (50mg Per mL) Carton (Ful08 0004 18)

Principal Display Panel – Fulvestrant Injection, 250 mg Per 5 mL (50mg Per mL) Carton (Ful08 0004 18)
Packaging label for Fulvestrant Injection 250 mg per 5 mL (50 mg per mL) by Meitheal Pharmaceuticals Inc. The label indicates the product is for intramuscular use, contains two single-dose prefilled syringes totaling 500 mg, and includes storage instructions to refrigerate and protect from light. The label includes the NDC 71288-555-86 and features usage instructions with illustrations.*

* 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.