Sildenafil
Product Images NDC 53217-293

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 53217-293). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aidarex Pharmaceuticals 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.

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Figure 6: Kaplan-meier Plot Of Mortality By Sildenafil Dose (Sildenafil 20mg 1)

A line chart depicting estimated cumulative mortality rate (%) over a 5-year period for three groups labeled High Dose, Medium Dose, and Low Dose. The x-axis represents time in years from 0 to 5, and the y-axis shows mortality rate percentage from 0 to 25%. A table above the graph indicates the number of subjects at risk at multiple time points for each dose group.*

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Chemical Structure (Sildenafil 20mg 2)

Chemical structure of Sildenafil, showing its molecular framework including sulfonamide, pyrazolo[4,3-d]pyrimidine, and piperazine ring systems with associated functional groups.*

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Figure 7. Effects Of Other Drugs On Sildenafil Pharmacokinetics (Sildenafil 20mg 3)

A dot plot chart illustrating the fold change with 90% confidence interval of pharmacokinetic parameters AUC and Cmax for Sildenafil when coadministered with various interacting drugs, including Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir, and Saquinavir. The chart also shows dosing recommendations based on these interactions, such as 'No dose adjustment' or 'Coadministration not recommended.'*

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Figure 8 Effects Of Sildenafil On Other Drugs (Sildenafil 20mg 4)

A chart depicting drug interaction effects of sildenafil at doses 25 mg, 50 mg, and 100 mg on various drugs. It presents fold changes with 90% confidence intervals for pharmacokinetic parameters (AUC, Cmax, INR AUC, INR Cmax, and bleeding time) relative to the interacting drug alone. The chart also includes dosage adjustment recommendations ranging from no dose adjustment to coadministration not recommended, specifically highlighting interactions with bosentan and ritonavir.*

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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) (Sildenafil 20mg 5)

A line chart titled 'Change from Baseline in 6-Minute Walk Distance (meters) at Weeks 4, 8, and 12 in Study 1: Mean (95% Confidence Interval).' The x-axis represents the week of study (Weeks 4, 8, 12), and the y-axis shows the change from baseline in meters, ranging from -20 to 80. Data are plotted for four groups: placebo, sildenafil 20 mg TID, sildenafil 40 mg TID, and sildenafil 80 mg TID, each marked with distinct symbols and error bars indicating 95% confidence intervals.*

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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) (Sildenafil 20mg 6)

A figure showing placebo-corrected changes from baseline in 6-minute walk distance (meters) at Week 12 across various subpopulations by study parameters. Subpopulations include baseline walk distance, etiology (Idiopathic PAH, PAH-CTD, PAH-surgical repair), PH functional class, gender, age, mean PAP, and PVRI, with mean values and 95% confidence intervals plotted for Sildenafil 20 mg TID compared to placebo.*

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Figure 11. Kaplan-meier Plot Of Time (in Days) To Clinical Worsening Of Pah In Study 2 (Sildenafil 20mg 7)

Kaplan-Meier plot showing time in days from randomization to clinical worsening of PAH in Study 2, comparing Sildenafil and placebo groups. The graph displays percentage of patients without a clinically worsening event over time, with Sildenafil showing a higher percentage remaining event-free compared to placebo up to 112 days.*

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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 (Sildenafil 20mg 8)

A line graph showing mean change from baseline measurements over 12 weeks for Sildenafil at doses of 1 mg, 5 mg, and 20 mg taken three times daily (TID). The y-axis represents change in meters, and the x-axis denotes weeks of study (4, 8, and 12). Each dose group is plotted with error bars indicating standard error of the mean.*

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Image Description (Sildenafil 20mg 9)

Sildenafil 20mg film-coated tablets, packaged by Aidarex Pharmaceuticals LLC, with 90 tablets per bottle. The label states Sildenafil Citrate, USP equivalent to Sildenafil 20mg, generic for Viagra. Manufactured by Aurobindo Pharma Ltd., India. The label includes lot number, expiration date, NDC 53217-0293-90, and prescription information. Tablets are described as white, round with a 'T' on one side and '27' on the reverse.*

* 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.