Fesoterodine Fumarate Tablet, Film Coated, Extended Release
Product Images NDC 65862-767

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Fesoterodine Fumarate (NDC 65862-767). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma 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

Figure 1: Change In Number Of Micturitions Per 24 H (study 1) (Fesoterodine Fig1)

A line chart titled 'Change in Number of Micturitions per 24 h (Study 1)' showing mean change from baseline in number of micturitions per 24 hours over 12 weeks. It compares placebo, fesoterodine fumarate extended-release tablets 4 mg, and 8 mg. The y-axis measures mean change from baseline (number of micturitions), and the x-axis shows weeks from 0 to 12. The chart illustrates greater reduction in micturitions with 8 mg and 4 mg doses compared to placebo over time.*

FDA Label Image

Figure 2: Change In Urge Incontinence Episodes Per 24 H (study 1) (Fesoterodine Fig2)

A line graph titled 'Change in Urge Incontinence Episodes per 24 h (Study 1)' showing mean change from baseline in urge incontinence episodes over 12 weeks. The graph compares placebo and Fesoterodine fumarate extended-release tablets at 4 mg and 8 mg doses. The x-axis represents weeks (0 to 12), and the y-axis shows mean change in episodes per 24 hours. Data indicate greater reduction in episodes with 8 mg dose compared to 4 mg and placebo over time.*

FDA Label Image

Figure 3: Change In Number Of Micturitions Per 24 H (study 2) (Fesoterodine Fig3)

Line graph titled 'Change in Number of Micturitions per 24 h (Study 2)' showing mean change from baseline in number of micturitions over 12 weeks. The x-axis represents time (in weeks), and the y-axis shows mean change from baseline (number of micturitions per 24 h). Three lines depict data for placebo (N=266), fesoterodine fumarate extended-release tablets 4 mg (N=267), and 8 mg (N=267). Both fesoterodine groups show a greater reduction in micturitions compared to placebo over time.*

FDA Label Image

Figure 4: Change In Urge Incontinence Episodes Per 24 H (study 2) (Fesoterodine Fig4)

A line graph titled 'Change in Urge Incontinence Episodes per 24 h (Study 2)' showing mean change from baseline in urge incontinence episodes over 12 weeks. The x-axis represents weeks (0 to 12), and the y-axis shows mean change from baseline (0 to -3 episodes). Three lines compare Placebo (N=205), Fesoterodine fumarate extended-release tablets 4 mg (N=228), and 8 mg (N=218), with the 8 mg dose showing the greatest reduction in episodes over time.*

FDA Label Image

Package Label-principal Display Panel (4 mg (30 Tablets Bottle))

Label for Fesoterodine Fumarate Extended-release Tablets 4 mg by Aurobindo Pharma Limited. The film-coated, extended-release oral tablet packaging is marked as Rx only and contains 30 tablets. The label includes dosage strength, storage instructions, distribution information, and a barcode.*

FDA Label Image

Package Label-principal Display Panel (8 mg (30 Tablets Bottle))

Label for Fesoterodine Fumarate extended-release tablets, 8 mg strength. The label indicates the product is a prescription drug, film-coated, oral tablet with 30 tablets per package. It includes storage instructions, dosing note to see prescribing information, and manufacturer details: Aurobindo Pharma USA, Inc. The label also features a barcode and an overprinting zone for coding.*

FDA Label Image

Chemical Structure (Fesoterodine Str)

Chemical structure of fesoterodine fumarate, showing the molecular arrangement of its atoms and bonds as represented by the structural formula in the image.*

* 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.