Dapagliflozin And Metformin Hydrochloride Tablet, Film Coated, Extended Release
Product Images NDC 63304-028

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Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Dapagliflozin And Metformin Hydrochloride (NDC 63304-028). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sun Pharmaceutical Industries, 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.

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Dapamet Label-10mg1000mg (Dapamet Label 10mg1000mg)

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Dapamet Label-10mg500mg (Dapamet Label 10mg500mg)

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Dapamet Label-5mg1000mg (Dapamet Label 5mg1000mg)

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Dapagliflozin Structural Formula (Dapagliflozin Structural Formula)

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Figure 1 (Figure 1)

Figure 1 (Figure 1)
This text provides data on CFB (change from baseline) in 24-hour urinary glucose levels with varying doses of dapagliflozin, a medication used to treat type 2 diabetes mellitus. The plot shows observed values for both healthy subjects and those with T2DM, along with fitted lines for each group. The graph displays the relationship between dapagliflozin dose and urinary glucose excretion over the specified range.*
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Figure 2 (Figure 2)

Figure 2 (Figure 2)
This text describes a study comparing the effects of Dapagliflozin 10mg + Metformin XR, Dapagliflozin 10mg, and Metformin XR on HbA1c levels over 24 weeks. The graphs show the adjusted mean change from baseline using longitudinal repeated measures and ANCOVA models, respectively. The study includes randomized subjects who completed the study without rescue, providing valuable insights into the efficacy of these treatments for managing HbA1c levels.*
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Figure 4 (Figure 4)

Figure 4 (Figure 4)
This is a data set presenting the number of patients at risk and the percentage of patients with an event over time for Dapagliflozin and Placebo. The data is collected at various time points up to 60 weeks. This information can be used to analyze the effectiveness and safety of Dapagliflozin compared to Placebo.*
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Figure 5 (Figure 5)

Figure 5 (Figure 5)
This text seems to be a statistical table showing data of patients at risk for Dapagliflozin treatment and Placebo over a period of months from randomization. It provides numbers of patients at risk at different time points, indicating the progression and outcomes over time for each group.*
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Figure 6 (Figure 6)

Figure 6 (Figure 6)
This is a graph comparing the usage of Dapagliflozin versus Placebo over a span of 32 months, showing a hazard ratio (HR) of 0.61 with a 95% confidence interval from 0.51 to 0.72. The number of patients at risk is also provided for both groups at various time points.*
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Figure 7a (Figure 7a)

Figure 7a (Figure 7a)
This appears to be a comparison of the medication Dapagliflozin with a placebo in terms of events occurring in patients over a period of months from randomization. The hazard ratio (HR) is reported as 0.74 with a 95% confidence interval (CI) of (0.65, 0.85) and a statistically significant p-value of less than 0.0001. The text also provides a timeline of months from randomization and the number of patients at risk for both Dapagliflozin and placebo at different time points.*
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Figure 7b (Figure 7b)

Figure 7b (Figure 7b)
This is a clinical trial data comparison between Dapagliflozin and Placebo over a span of 36 months. The hazard ratio (HR) was calculated at 0.82 with a 95% confidence interval (CI) of 0.73 to 0.92. The p-value associated with this result was determined to be 0.0008. The number of patients at risk is listed at different time points throughout the trial period, starting with 3131 patients at the beginning and dwindling down to 389 patients by the 36th month. This data provides insights into the effectiveness and safety of Dapagliflozin compared to a placebo in this specific study.*
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Figure 8 (Figure 8)

Figure 8 (Figure 8)
This is a table from a study comparing the efficacy of a drug called Dapagliflozin to a placebo in patients with different Left Ventricular Ejection Fraction (LVEF) categories. The Heart Rate (HR) and Confidence Intervals (CI) are also provided for each category. Results suggest a potential benefit of Dapagliflozin over the placebo in improving outcomes based on the given HR values.*
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Metformin HCl Structural Formula (Metformin HCl Structural Formula)

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