Sildenafil
Product Images NDC 50436-5517

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Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Sildenafil (NDC 50436-5517). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Unit Dose Services, 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 01)

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Sildenafil Citrate Structural Formula (Image 02)

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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 05)

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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 06)

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 06)
The document presents a table with data related to the efficacy of Sildenafil in treating Pulmonary Arterial Hypertension. The table includes patient gender, age, disease classification, etiology, and functional capacity. It also displays the mean pulmonary arterial pressure, placebo-corrected change in 6-minute walk distance, and PVRI.*
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Figure 11. Kaplan-meier Plot Of Time (in Days) To Clinical Worsening Of Pah In Study 2 (Image 07)

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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 08)

Figure 12. Mean Change From Baseline In Six Minute Walk (meters) By Visit To Week 12 – Itt Population Sildenafil Protocol A1481244 (Image 08)
This appears to be a chart or graph related to a study on the effects of different doses of sildenafil (a medication used for erectile dysfunction) on participants over a period of 12 weeks. The x-axis shows the weeks of the study, while the y-axis indicates the change from baseline in meters. The plot shows the mean change from baseline for each treatment (represented by different colored lines) at each visit up to week 12. The chart appears to compare the effects of different doses of sildenafil (10 mg and 20 mg taken three times a day) with a placebo.*
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Label Image (Lbl504365517)

Label Image (Lbl504365517)
This is a description of a medication called Sildenafil with a strength of 20mg. The NDC number is 50436.5517-1, and it appears to come in a unit dose form. However, due to the incomplete and fragmented nature of the text, it is possible that there is missing or erroneous information, and some parts of the text are not legible or understandable.*
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This is a drug interaction table that lists the drugs Atorvastatin, Azithromycin, Bosentan, Cimetidine, Erythromycin, Maalox, Oral Contraceptives, Ritonavir and Saquinavirt. The table shows the fold change and 90% Confidence Interval (CI) recommendation indicating whether dose adjustment is needed or not for these drugs when taken with Sildenafil. It also includes a note stating that co-administration with bosentan therapy is not recommended and that there is no benefit on exercise capacity.*
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This is a list of drugs that interact with Acenocoumarol, specifying their fold change and 90% CI recommendations for INR AUC and Cmax with either dose adjustment or no dose adjustment, or if it is not recommended. The table also includes a chart showing the change relative to the interacting drug alone with a solid line at x=1, and some notes on Doxazosin1, Doxazosin2, Doxazosin3, Ritonavir and Bosentan.*

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