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

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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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FDA Label Image

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Image (48ba7aba E3ad 4696 859b 59582464bd5b 02)
This text provides survival probability data in a study labeled "JMDB." It includes information on survival time in months for different groups of patients, illustrated using Kaplan-Meier curves for overall survival. The numbers of patients at risk at various time points are also shown.*
FDA Label Image

Image (48ba7aba E3ad 4696 859b 59582464bd5b 03)

Image (48ba7aba E3ad 4696 859b 59582464bd5b 03)
This is a figure showing Kaplan-Meier Curves for Overall Survival in non-squamous NSCLC in a study named JMDB. The text also includes data related to Survival Time in months and the number of patients at risk.*
FDA Label Image

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Image (48ba7aba E3ad 4696 859b 59582464bd5b 04)
The text mentions survival probability in a study comparing Pemetrexed + Cisplatin (PC) and Gemcitabine + Cisplatin (GC) in squamous non-small cell lung cancer (NSCLC). Information such as survival times in months and the number of patients at risk over time is included. The data is presented in a Kaplan-Meier curve for overall survival in Study JMDB.*
FDA Label Image

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Image (48ba7aba E3ad 4696 859b 59582464bd5b 05)
This data pertains to the survival probability and patients at risk in a study comparing pemetrexed with placebo. The information includes the number of patients at risk over different time intervals in months, presented in the form of Kaplan-Meier curves for overall survival in Study JMEN.*
FDA Label Image

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Image (48ba7aba E3ad 4696 859b 59582464bd5b 06)
This text provides data on the survival probability of patients with non-squamous NSCLC in a study comparing Pemetrexed and Placebo. The information includes survival time in months and the number of patients at risk at different time points. The Kaplan-Meier curves for overall survival are also mentioned in the study titled JMEN.*
FDA Label Image

Image (48ba7aba E3ad 4696 859b 59582464bd5b 07)

Image (48ba7aba E3ad 4696 859b 59582464bd5b 07)
This is a data showing the survival probability and patients at risk in a study on Squamous NSCLC evaluating Pemetrexed and Placebo. The Kaplan-Meier curves for overall survival are depicted in Figure 6. The data indicates the number of patients at risk at different time intervals for each treatment group.*
FDA Label Image

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Image (48ba7aba E3ad 4696 859b 59582464bd5b 08)
This is a statistical analysis of survival probability based on the Kaplan-Meier curves for overall survival in the PARAMOUNT study. It shows the survival time in months for patients treated with Pemetrexed and Placebo, along with the number of patients at risk at different time points.*
FDA Label Image

Image (48ba7aba E3ad 4696 859b 59582464bd5b 09)

Image (48ba7aba E3ad 4696 859b 59582464bd5b 09)
This text provides data on the Kaplan-Meier curves for overall survival in a study comparing Pemetrexed + Cisplatin to Cisplatin alone. It shows the survival time in months and the number of patients at risk over various time points. This information can be used to evaluate the effectiveness of the treatment regimens in the study.*
FDA Label Image

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

Axtle (pemetrexed) For Injection -container Label- -100mg/vial (48ba7aba E3ad 4696 859b 59582464bd5b 10)
This text appears to be a label providing information about a drug product, specifically a Varnish Area with the code number AP/DRUGS/03/2011. The product is described as pemetrexed for injection with a strength of 100 mg/vial, intended for intravenous use only. It further mentions that it is a sterile single-dose vial and instructs to discard any unused portion. The label also includes an NDC number of 83831-131-01 for identification purposes.*
FDA Label Image

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

Axtle (pemetrexed) For Injection -carton Label -100mg/vial (48ba7aba E3ad 4696 859b 59582464bd5b 11)
This text appears to be a label or packaging details for a pharmaceutical product named AXTLE™. It includes information about batch details, barcode, manufacturing information, dosage, administration instructions, storage instructions, and warnings. The product is a sterile single-dose vial for intravenous use containing 100 mg of pemetrexed. It is advised to discard any unused portion after use and store the product at controlled room temperature. The manufacturing details suggest it is made by Awpca Parma, LLG in New Jersey, USA.*
FDA Label Image

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

FDA Label Image

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

Axtle (pemetrexed) For Injection -carton Label -500mg/vial (48ba7aba E3ad 4696 859b 59582464bd5b 13)
This text provides detailed information about the medication AXTLE™ (pemetrexed) for injection. It includes instructions for reconstitution, dosage, administration, storage conditions, and warnings about the hazardous nature of the drug. The product is a sterile single-dose vial containing 500 mg of pemetrexed. It should be reconstituted with 5% Dextrose Injection and further diluted before use. The storage requirements include controlled room temperature and refrigeration for both reconstituted and infusion solutions. Specific details such as NDC number, manufacturing information, expiration date, and barcode are also provided on the packaging.*
FDA Label Image

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FDA Label Image

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* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.