Sildenafil Tablet, Film Coated
Product Images NDC 71205-509

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 71205-509). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Proficient Rx Lp, 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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Figure 6: Kaplan-meier Plot Of Mortality By Sildenafil Dose (Image 1)

A line graph showing estimated cumulative mortality rate (%) over time (years) for three dosing groups: High Dose, Medium Dose, and Low Dose. The graph includes stepwise lines representing mortality rates, with High Dose and Medium Dose groups having higher mortality rates than the Low Dose group over approximately 5 years. Number at risk values are indicated above the graph for each group at multiple time points.*

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Sildenafil Citrate Structural Formula (Image 2)

Chemical structure of Sildenafil shown as a two-dimensional molecular diagram with labeled bonds and atoms, including carbon, nitrogen, oxygen, and sulfur atoms, representing the active ingredient in the drug Sildenafil 20 mg tablet by Proficient Rx LP.*

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Pharmacokinetic interaction chart showing fold change and 90% confidence intervals of area under the curve (AUC) and peak concentration (Cmax) of sildenafil when coadministered with various drugs. The chart compares changes relative to sildenafil alone, with a vertical solid line at 1 indicating no change. Recommendations for dose adjustment are provided for each interacting drug.*

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Figure 8: Effects Of Sildenafil On Other Drugs (Image 4)

A chart showing fold change and 90% confidence intervals for various interacting drugs with sildenafil. The x-axis represents change relative to the interacting drug alone, with a vertical line at 1. The chart includes drug names, parameters like AUC, Cmax, and recommendations for dose adjustments, mostly stating no dose adjustment needed except for ritonavir where coadministration is not recommended.*

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Figure 9. Change From Baseline In 6-minute Walk Distance (meters) At Weeks 4, 8, And 12 In Study 1: Mean (95% Confidence Interval) (Image 5)

A line graph showing change from baseline (in meters) over weeks 4, 8, and 12 of study for four groups: Placebo, Sildenafil 20 mg TID, Sildenafil 40 mg TID, and Sildenafil 80 mg TID. The vertical axis measures change from baseline, and the horizontal axis represents the week of study. Each group is represented with different symbols and error bars indicating variability.*

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Figure 10. Placebo-corrected Change From Baseline In 6-minute Walk Distance (meters) At Week 12 By Study Subpopulation In Study 1: Mean (95% Confidence Interval) (Image 6)

A forest plot showing the placebo-corrected change in 6-minute walk distance (meters) for Sildenafil 20 mg TID, categorized by baseline walk distance, etiology of pulmonary arterial hypertension (PAH), functional class, gender, age, mean pulmonary arterial pressure (PAP), and pulmonary vascular resistance index (PVRI). Each subgroup comparison includes point estimates with confidence intervals, indicating the treatment effect across different patient characteristics.*

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Figure 11. Kaplan-meier Plot Of Time (in Days) To Clinical Worsening Of Pah In Study 2 (Image 7)

A survival curve chart showing the percentage of subjects without a clinically worsening event over days from randomization comparing Sildenafil with Placebo. The x-axis represents days from randomization (0 to 112), and the y-axis shows the percentage without worsening (0% to 100%). The chart includes two lines: a dashed line for Sildenafil and a solid line for Placebo, highlighting differences in clinical event rates over time.*

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Figure 12. Mean Change From Baseline In Six Minute Walk (meters) By Visit To Week 12 – Itt Population Sildenafil Protocol A1481244 (Image 8)

A line chart depicting the mean change from baseline in meters over 12 weeks for three Sildenafil doses: 1 mg, 5 mg, and 20 mg TID. The x-axis shows study weeks (4, 8, 12), and the y-axis shows change from baseline. Error bars represent standard error for each dose at each visit.*

FDA Label Image

71205-509-90 (Image 9)

Label for Sildenafil 20 mg tablets by Proficient Rx LP. It shows a quantity of 90 film-coated tablets, each containing 20 mg sildenafil citrate. The tablets are described as white, round, biconvex, and debossed with "TEVA" and "5517". The product is relabeled by Proficient Rx LP in Thousand Oaks, CA, and manufactured in India by Teva Pharmaceuticals USA, Inc.*

* 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.