Structural Formula (Fig 01)
Tadalafil Tablet
Product Images NDC 76420-546
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Product Visual Gallery
This gallery contains 20 technical images submitted to the FDA as part of the official labeling for Tadalafil (NDC 76420-546). 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.
Product Images & Figures Index
Figure 1 (Fig 02)
Figure 2 (Fig 03)
This is not-available.*
Figure 3 (Fig 04)
Figure 4 (Fig 05)
This information provides data on Plasma Tadalafil Concentration (µg/L) over time after the administration of different doses of Tadalafil. The concentrations are measured at various time points from 0 to 120 hours for a single 20-mg dose, a single 5-mg dose, and once-daily 5-mg doses following five days of administration. The chart shows how the plasma concentration of Tadalafil changes over time with different dosing regimens.*
Image (Fig 06)
Change from Baseline in IPSS Total Score is being evaluated for Tadalafil 5 mg compared to Placebo over a treatment period of 12 weeks.*
Image (Fig 07)
Change from Baseline in IPSS Total Score can be evaluated through this data comparison between Tadalafil 5 mg and Placebo over a span of 12 weeks. The asterisk indicates a significant difference at p<0.01.*
Image (Fig 08)
This text provides information regarding the LS mean change from baseline in a study comparing Tadalafil/Finasteride to Placebo/Finasteride over 12 and 26 weeks of therapy. It includes p-values for the comparison and mentions the Least Squares Treatment Difference.*
Figure 8 (Fig 09)
Change from Baseline in IPSS Total Score of Tadalafil 5mg compared to Placebo after 12 weeks of treatment. Statistically significant difference (p<0.01).*
Label (Fig 10)
This text seems to be a description of different Tadalafil Tablets with varying quantities and manufacturing details. The tablets are manufactured by Enovachem for Tarant Pharma, and there are different pack sizes available (30, 60, 90 tablets). The lot numbers and batch numbers for each type of tablet are also mentioned, along with precautions to store the tablets in a controlled room temperature environment.*
11 (Table 11)
This text provides a comparison of the mean endpoint and change from baseline for primary efficacy variables in two primary US trials evaluating the effects of Placebo and Tadalafil Tablets (20mg). The variables included are the EF Domain Score, Insertion of Penis (SEP2), and Maintenance of Erection (SEP3). The results show the numerical values for these variables in the placebo and Tadalafil tablet groups, along with p-values indicating statistical significance. The data suggests that Tadalafil tablets have a positive impact on these efficacy variables compared to placebo in the trials.*
12 (Table 12)
13 (Table 13)
This text provides data on the mean post-baseline success rate and change from baseline for SEP Question 2 ("Were you able to insert your penis into the partner's vagina?") in the General ED Population from five pivotal trials outside the US. The trials compared the effects of Placebo, Tadalafil Tablets 5mg, 10mg, and 20mg doses. The results show varying percentages of success rate changes from baseline across different studies, indicating the effectiveness of Tadalafil Tablets in this population segment. The text mentions Study C, Study D, Study E, Study F, and Study G, each with their respective success rate change percentages.*
14 (Table 14)
Table 14 provides data on the mean post-baseline success rate and change from baseline for SEP Question 3, focusing on the duration of erections for successful intercourse in the general erectile dysfunction population across five pivotal trials. The trials explore the efficacy of placebo, 5mg, 10mg, and 20mg tadalafil tablets. The results displayed varying success rates and changes from baseline across the different studies, with statistical significance indicated. Notably, Study F had a treatment duration of 6 months.*
15 (Table 15)
16 (Table 16)
This text presents a table showing the mean endpoint and change from baseline for the primary efficacy variables in a study involving patients who developed erectile dysfunction following bilateral nerve-sparing radical prostatectomy. The data includes comparisons between a placebo and Tadalafil tablets of 20mg strength for parameters such as EF domain score, insertion of penis (SEPD), and maintenance of erection (SEP3). It appears to be evaluating the effectiveness of Tadalafil in this patient population.*
17 (Table 17)
This text provides data on the mean endpoint and change from baseline for the primary efficacy variables in the studies comparing two Tadalafil tablets for once daily use. It includes information on the EF Domain Score, Insertion of Penis (SEP2), and Maintenance of Erection (SEP3) for each tablet dosage. The study details mention a twenty-four-week study conducted in the US and a twelve-week study conducted outside the US.*
18 (Table 18)
This section provides the mean endpoint and change from baseline data for the primary efficacy variables in a study of Tadalafil tablets for once daily use in patients with erectile dysfunction (ED) and diabetes. The table includes data on placebo and Tadalafil tablets at a dose of 2.5mg, highlighting the differences in endpoint scores and changes from baseline for parameters such as EF Domain Score, Insertion of Penis, and Maintenance of Erection. The results indicate a statistically significant difference from placebo for Tadalafil tablets.*
19 (Table 19)
20 (Table 20)
This text provides information on the Mean Total IPSS Changes in BPH Patients treated with Tadalafil Tablets and Finasteride. The data includes the changes in symptoms from baseline to weeks 12, 26, and 47, compared between the treatment groups. It also mentions the statistical significance of the differences observed. The results are based on an ITT population and analyzed using a mixed model for repeated measurements.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
