Fesoterodine

FDA Drug Profile

Fesoterodine is listed in the FDA National Drug Code directory with 2 NDC codes. Available dosage form: powder.

Drug Details

Generic Name
Fesoterodine
Brand Names
N/A
Application Number
Sponsor
Raks Pharma Pvt. Limited
NDC Codes
2
Dosage Forms
POWDER
Routes
N/A
Active Ingredients
FESOTERODINE FUMARATE, FESOTERODINE

Indications and Usage

1 INDICATIONS AND USAGE Fesoterodine fumarate extended-release are indicated for the treatment of: • Overactive bladder(OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. ( 1.1 ) • Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. ( 1.2) 1.1 Adult Overactive Bladder Fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. 1.2 Pediatric Neurogenic Detrusor Overactivity Fesoterodine fumarate extended-release tablets are indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older with a body weight greater than 25 kg.