Fesoterodine Fumarate Tablet, Extended Release
Product Images NDC 46708-175

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Fesoterodine Fumarate (NDC 46708-175). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Alembic Pharmaceuticals Limited, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Fesoterodine-figure1.jpg (Fesoterodine Figure1)

A line chart titled 'Change in Number of Micturitions per 24 h (Study 1)' showing mean change from baseline over 12 weeks. The x-axis represents weeks, and the y-axis represents mean change in number of micturitions per 24 hours. Four data lines are plotted: placebo, fesoterodine fumarate 4 mg, and fesoterodine fumarate 8 mg with respective subject numbers (N=279, N=265, N=276). The fesoterodine groups show a greater decrease in micturition frequency compared to placebo over the study period.*

FDA Label Image

Fesoterodine-figure2.jpg (Fesoterodine Figure2)

A line graph titled 'Change in Urge Incontinence Episodes per 24 h (Study 1),' comparing mean change from baseline in urge incontinence episodes over 12 weeks. Three groups are shown: Placebo (N=211), Fesoterodine fumarate 4 mg (N=199), and 8 mg (N=223). The y-axis represents the mean change, ranging from 0 to -3 episodes per 24 hours, and the x-axis shows time in weeks (0, 2, 8, 12). The 8 mg dose shows the greatest reduction in episodes over time, followed by 4 mg, and placebo shows the least improvement.*

FDA Label Image

Fesoterodine-figure3.jpg (Fesoterodine Figure3)

A line graph titled 'Change in Number of Micturitions per 24 h (Study 2)' showing mean change from baseline in number of micturitions over a 12-week period. It compares three groups: placebo, fesoterodine fumarate 4 mg, and fesoterodine fumarate 8 mg. Both fesoterodine groups show a greater reduction in micturitions than placebo, with the lines for 4 mg and 8 mg closely overlapping below the placebo line throughout the study duration.*

FDA Label Image

Fesoterodine-figure4.jpg (Fesoterodine Figure4)

A line graph titled 'Change in Urge Incontinence Episodes per 24 h (Study 2)' showing mean change from baseline over 12 weeks. It compares three groups: Placebo (dotted line with circles), Fesoterodine fumarate 4 mg (dashed line with triangles), and Fesoterodine fumarate 8 mg (solid line with squares). The y-axis indicates the mean change in episodes per 24 hours, decreasing from 0 to -3, and the x-axis represents weeks from 0 to 12. Both Fesoterodine fumarate groups show greater reductions compared to placebo.*

FDA Label Image

30 Tablets (Fesoterodine mg 4)

Label for Fesoterodine Fumarate Extended-release Tablets 4 mg, oral dosage form. The label indicates this is a 30-tablet package of extended-release film-coated tablets distributed by Alembic Pharmaceuticals Limited. It includes storage instructions and a barcode, specifying the product is prescription only.*

FDA Label Image

30 Tablets (Fesoterodine mg 8)

Fesoterodine Fumarate Extended-release Tablets 8 mg in a carton label for oral administration. The package contains 30 tablets. The label includes storage instructions, manufacturer Alembic Pharmaceuticals Limited, and dosage directions to swallow whole without chewing or crushing. The label shows NDC 46708-176-30 and includes a barcode.*

FDA Label Image

Structure (Fesoterodine Str)

Chemical structure of Fesoterodine Fumarate, the active ingredient in the medication. The image displays the molecular arrangement including functional groups and the fumarate component.*

* 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.