Argatroban Injection, Solution
Product Images NDC 67457-212

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Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Argatroban (NDC 67457-212). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mylan Institutional 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

Argatroban Injection 250 mg/2.5 mL Carton Label (Image 01)

FDA Label Image

Figure 1: Relationship At Steady-state Between Argatroban Dose, Plasma Argatroban Concentration And Anticoagulant Effect (Image 02)

Figure 1: Relationship At Steady-state Between Argatroban Dose, Plasma Argatroban Concentration And Anticoagulant Effect (Image 02)
This is a chart that shows the results of a test for W aPTT in seconds (sec) and the plasma concentration of Argatroban in micrograms per milliliter (mcg/mL). There are also measurements for infusion dose in meg/kg/min. The chart seems to be related to a 19-year-old patient.*
FDA Label Image

Figure 2: Inr Relationship Of Argatroban Plus Warfarin Versus Warfarin Alone (Image 03)

FDA Label Image

Figure 3: Time To First Event For The Composite Efficacy Endpoint: Hit Patients (Image 04)

Figure 3: Time To First Event For The Composite Efficacy Endpoint: Hit Patients (Image 04)
This text is a table showing the results of a study with two groups of participants, one receiving Aralroban and another serving as the Historical Control. The table presents the number of participants in each group as well as the p-value obtained from the study. The "censored" column indicates that no clinical endpoint was observed during the follow-up period, which was a maximum of 37 days.*
FDA Label Image

Figure 4: Time To First Event For The Composite Efficacy Endpoint: Hitts Patients (Image 05)

Figure 4: Time To First Event For The Composite Efficacy Endpoint: Hitts Patients (Image 05)
This study, referred to as "STUDY 1", compared the effectiveness of Argatroban (administered to 144 participants, with 81 being censored) to a historical control group (consisting of 46 individuals, with 20% being censored). The study day was measured at 21, 28, and 35 days. The term "censored" indicates that no clinical endpoint (such as death, amputation, or new thrombosis) was observed during the follow-up period, which had a maximum duration of 37 days. A p-value of 0.018 was obtained suggesting a statistically significant difference between the two groups.*
FDA Label Image

Argatroban Structural Formula (Image 06)

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