Figure-1 (Figure 1)
Sildenafil Citrate Tablet
Product Images NDC 76420-613
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Sildenafil Citrate (NDC 76420-613). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Asclemed Usa, 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.
Figure-2 (Figure 2)
Figure-5 (Figure 5)
Figure-6 (Figure 6)
4 (Figure 7)
This text appears to be related to a study involving different dosages of a medication called Sildenafil over a 12-week period. It shows the change from the initial baseline distance in meters for various timepoints. The dosages mentioned in the study include 20mg TID, 40mg TID, and 80mg TID of Sildenafil. The study seems to compare the effects of these dosages with a placebo group.*
5 (Figure 8)
Table 6 (Table 6)
Table 6 provides hazard ratios for overall survival, specifically assessed in the Intent To Treat population. The table includes data on the administration of Sildenafil at different dosages (5 mg, 20 mg, and 80 mg). The table also includes information on the number of patient-years of follow-up, the number of deaths, and the breakdown of deaths that occurred while on treatment and off treatment. Hazard ratios are estimated relative to the 5 mg and 20 mg dosages of Sildenafil. It is important to note that deaths within 7 days of the last dose were considered "On treatment" and may include deaths that occurred after discontinuation from the study treatment. The hazard ratio estimates were obtained from a proportional hazards model stratified by previous PAH treatment and the etiology of PAH.*
Table 7 (Table 7)
Table 7 presents hazard ratios for the time to the first event of clinical worsening in the intent-to-treat population. The table shows data on the use of different dosages of Sildenafil (5mg, 20mg, and 80mg) and their association with clinical worsening events. The number of patients experiencing clinical worsening, including disease progression, hospitalization for pulmonary arterial hypertension (PAH), and death, is provided for each dosage. Hazard ratios relative to the 5mg and 20mg dosages are also presented, along with their corresponding confidence intervals and p-values. It is noted that the use of 5mg of Sildenafil is not an approved dosage. The table includes relevant abbreviations and explains the criteria used for defining clinical worsening events. The hazard ratio estimates are derived from the proportional hazards model, and the p-values are based on the Wald test.*
Image Description (Label)
1 (Str 02)
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
