Fulvestrant Injection
Product Images NDC 16729-436

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Fulvestrant (NDC 16729-436). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Accord Healthcare 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

Fulvestrant (Fulvestrant Injection Carton)

Fulvestrant Injection 250 mg/5 mL (50 mg/mL) carton label from Accord Healthcare Inc. The label states it contains two single-dose prefilled syringes, each with 250 mg/5 mL for intramuscular use only. Instructions for administration, storage (refrigerate 2° to 8°C), and warnings are included. The label features NDC 16729-436-30 and a barcode, along with manufacturer details and diagrams for injection use.*

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Chemical Structure Fulvestrant (Fulvestrant Injection Chemical Structure)

Chemical structure of Fulvestrant, showing its steroidal backbone with hydroxyl groups, alkyl chains, sulfoxide, and trifluoromethyl substituents as part of the molecular diagram.*

FDA Label Image

Figure 1 (Fulvestrant Injection Figure 1)

An instructional illustration showing how to prepare an injection with a syringe. The left side depicts a hand wearing a glove removing a needle cap from a syringe. The right side shows a close-up diagram of the syringe needle components labeled A, B, and C.*

FDA Label Image

Figure_10 (Fulvestrant Injection Figure 10)

A Kaplan-Meier survival curve graph showing overall survival probability (%) over time in months for patients treated with Fulvestrant plus Palbociclib versus Fulvestrant plus placebo. The graph includes labeled survival curves and numbers of patients at risk at various time points for each treatment group.*

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Figure 11 (Fulvestrant Injection Figure 11)

A Kaplan-Meier curve illustrating progression-free survival probability (%) over time (months) for patients treated with Fulvestrant plus Abemaciclib versus Fulvestrant plus Placebo. The chart includes censored observations markers and a risk table showing the number of patients at risk at various time points up to 30 months.*

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Figure 12 (Fulvestrant Injection Figure 12)

A survival probability curve chart comparing Fulvestrant plus Abemaciclib versus Fulvestrant plus Placebo over time in months. The vertical axis shows survival probability in percentage, and the horizontal axis shows time up to 57 months. It includes censored observations and patient risk counts for each group at multiple time points.*

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Figure 13 (Fulvestrant Injection Figure 13)

A Kaplan-Meier survival curve chart showing event-free probability (%) over time (months) comparing two groups: Fulvestrant plus Ribociclib and Fulvestrant plus Placebo. The graph includes censoring times and the number of patients at risk at various time points up to 26 months.*

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Figure 14 (Fulvestrant Injection Figure 14)

A Kaplan-Meier survival probability curve depicting event-free probability (%) over time in months. The chart compares Fulvestrant with Ribociclib (N=484) to Fulvestrant with Placebo (N=242), including censoring times and the number of patients at risk at various time points up to 48 months.*

FDA Label Image

Figure 2 (Fulvestrant Injection Figure 2)

Instructional diagram showing the preparation of an intramuscular injection using FULVESTRANT. The left panel illustrates a person pulling the plunger of a syringe. The right panel labels parts of the injection apparatus: A is the protective cap, B is the needle cover, and C is the vial top.*

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Figure 3 (Fulvestrant Injection Figure 3)

An instructional line drawing illustrating hands holding a syringe and vial, depicting the process of preparing an injection by withdrawing liquid from the vial into the syringe. The illustration is related to the administration of FULVESTRANT 250 mg/5 mL intramuscular injection by Accord Healthcare Inc.*

FDA Label Image

Figure 4 (Fulvestrant Injection Figure 4)

An instructional diagram showing the parts of a syringe with an attached needle. The image highlights the needle tip and the plunger mechanism, likely illustrating proper usage or assembly for the FULVESTRANT intramuscular injection.*

FDA Label Image

Figure 5 (Fulvestrant Injection Figure 5)

An instructional illustration showing a hand holding a syringe with an arrow indicating the direction to remove the needle cap. This image likely demonstrates a step in preparing the FULVESTRANT injection for intramuscular administration.*

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Fig 6 Kaplan-maier Pfs: Study 1 Itt Population (Fulvestrant Injection Figure 6)

A line graph showing progression free survival over time (months) for two dosages of Fulvestrant injection (250 mg and 500 mg). The y-axis represents the proportion of patients progression free, decreasing from 1.0 to 0.0, and the x-axis shows time in months up to 45. Two survival curves are presented, one dashed for Fulvestrant 250 mg and one solid for Fulvestrant 500 mg, with associated patient numbers at risk listed below the graph for various time points.*

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Figure 7 Kaplan-meier Os (minimum Follow-up Duration Of 50 Months): Confirm Itt Population (Fulvestrant Injection Figure 7)

A Kaplan-Meier survival curve chart comparing the proportion of patients alive over time in months for Fulvestrant injections at 250 mg and 500 mg doses. The chart includes risk tables for both dose groups and notes on censored observations and statistical significance.*

FDA Label Image

Figure_8.jpg (Fulvestrant Injection Figure 8)

A Kaplan-Meier survival curve chart displaying the probability of progression-free survival (PFS) over time in months from randomization. The chart compares two treatment groups: Fulvestrant 500 mg and Anastrozole 1 mg, with accompanying numbers of patients at risk listed below the time axis for each group.*

FDA Label Image

Figure_9 (Fulvestrant Injection Figure 9)

A Kaplan-Meier plot showing progression-free survival probability (%) over time in months for two patient groups: Fulvestrant with palbociclib versus Fulvestrant with placebo. The graph includes a risk table indicating the number of patients at risk in each group across different time points up to 14 months.*

FDA Label Image

Fulvestrant (Fulvestrant Injection Label)

Label for Fulvestrant Injection 250 mg/5 mL (50 mg/mL) by Accord Healthcare Inc. The label indicates intramuscular use only and includes instructions about single-dose prefilled syringes for a 500 mg dose. Manufactured by Intas Pharmaceuticals Limited, India. The label also features NDC 16729-436-31 and barcode information, along with storage instructions to protect from light.*

* 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.