Axtle Injection, Powder, Lyophilized, For Solution
Product Images NDC 83831-131

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Axtle (NDC 83831-131). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Avyxa Pharma, 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

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Chemical structure diagram of pemetrexed, the active ingredient in AXTLE injection powder. The structure includes potassium carboxylate groups and a pteridine-based core, indicating the lyophilized formulation for intravenous use.*

FDA Label Image

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A Kaplan-Meier survival curve graph comparing overall survival times over 30 months between two treatment groups: Pemetrexed + Cisplatin (PC) represented by a solid line, and Gemcitabine + Cisplatin (GC) represented by a dotted line. The y-axis shows survival probability from 0 to 1, and the x-axis shows survival time in months. Below the graph, a table indicates the number of patients at risk over time for each treatment group.*

FDA Label Image

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A Kaplan-Meier survival curve chart showing overall survival probability over time in months for two treatment groups: Pemetrexed + Cisplatin (PC) and Gemcitabine + Cisplatin (GC). The x-axis represents survival time in months up to 30 months, and the y-axis shows survival probability from 0 to 1. Patient counts at risk are listed below the x-axis for both groups at different time points.*

FDA Label Image

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A Kaplan-Meier survival curve chart illustrating overall survival probability over time (months) for two treatment groups: Pemetrexed + Cisplatin (PC) and Gemcitabine + Cisplatin (GC) in patients with squamous NSCLC. The chart includes patient risk numbers at various time points up to 30 months.*

FDA Label Image

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A Kaplan-Meier survival curve chart depicting overall survival probability over time in months for two groups: one treated with pemetrexed and a placebo group. The chart shows a generally higher survival probability for the pemetrexed group compared to placebo. The number of patients at risk at various time points is listed below the graph.*

FDA Label Image

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A Kaplan-Meier survival curve chart illustrating overall survival probability over time in months, comparing pemetrexed and placebo treatments in non-squamous NSCLC patients from the JMEN study. The chart includes survival curves for each group and a table showing the number of patients at risk at various time points up to 42 months.*

FDA Label Image

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Kaplan-Meier survival probability curves comparing overall survival over time in months for patients treated with pemetrexed versus placebo in a study of squamous non-small cell lung cancer (NSCLC). The graph includes a risk table showing the number of patients at risk over the study period for each group. Survival probability declines over approximately 42 months for both groups.*

FDA Label Image

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A Kaplan-Meier survival curve chart illustrating overall survival probability over time in months for two groups: one treated with Pemetrexed and a placebo group. The chart includes a survival probability axis from 0.0 to 1.0 and a timeline extending to 36 months. Patient counts at risk are listed below the time axis for each group.*

FDA Label Image

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A Kaplan-Meier survival curve chart showing overall survival probability over time in months. It compares two treatment groups: Pemetrexed + Cisplatin (solid line) and Cisplatin alone (dashed line). The y-axis represents survival probability, and the x-axis shows survival time in months, with patient counts at risk displayed below the graph.*

FDA Label Image

Axtle (pemetrexed) For Injection -container Label- -100mg/vial (48ba7aba E3ad 4696 859b 59582464bd5b 10)

Label for AXTLE (pemetrexed) for Injection 100 mg/vial, lyophilized powder for intravenous use. The label includes a warning that this is a hazardous drug, and specifies the vial contains 100 mg pemetrexed equivalent to 118.3 mg pemetrexed dipotassium. Manufactured by Avyxa Pharma, LLC, New Jersey, USA, made in India. The label also has barcode and placeholder for lot and expiration dates.*

FDA Label Image

Axtle (pemetrexed) For Injection -carton Label -100mg/vial (48ba7aba E3ad 4696 859b 59582464bd5b 11)

Packaging label for AXTLE (pemetrexed) injection, 100 mg/vial. The label indicates it is a sterile single-dose vial for intravenous use only, labeled as a hazardous drug. The manufacturer is Avyxa Pharma, LLC. The label includes storage instructions, reconstitution details, and a barcode. The product is made in India.*

FDA Label Image

Axtle (pemetrexed) For Injection -container Label- -500mg/vial (48ba7aba E3ad 4696 859b 59582464bd5b 12)

Label for AXTLE (pemetrexed) injection 500 mg/vial, a sterile single-dose vial intended for intravenous use. The label includes storage instructions, manufacturer information for Avyxa Pharma, LLC, and warnings. The powder is lyophilized for solution preparation. Product is Rx only.*

FDA Label Image

Axtle (pemetrexed) For Injection -carton Label -500mg/vial (48ba7aba E3ad 4696 859b 59582464bd5b 13)

Packaging label for AXTLE (pemetrexed) Injection, 500 mg/vial, a sterile single-dose vial for intravenous use only. The label advises to discard unused portions and includes storage and reconstitution instructions. Manufactured for Avyxa Pharma, LLC. The label features dosage, hazard warning, and barcode details.*

FDA Label Image

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FDA Label Image

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* 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.