Alfuzosin hydrochloride

FDA Drug Profile — Alfuzosin hydrochloride

Drug Details

Generic Name
Alfuzosin hydrochloride
Brand Names
Alfuzosin hydrochloride
Application Number
ANDA203192
Sponsor
Northwind Health Company, LLC
NDC Codes
5
Dosage Forms
TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients
ALFUZOSIN HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Alfuzosin hydrochloride extended-release tablets, USP, an alpha adrenergic antagonist, are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. ( 1 ) Important Limitations of Use: Alfuzosin hydrochloride extended-release tablets, USP are not indicated for treatment of hypertension. ( 1.1 ) Alfuzosin hydrochloride extended-release tablets, USP are not indicated for use in pediatric population. ( 1.1 , 8.4 , 12.3 ) Alfuzosin hydrochloride extended-release tablets, USP are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. 1.1 Important Limitations of Use Alfuzosin hydrochloride extended-release tablets, USP are not indicated for the treatment of hypertension. Alfuzosin hydrochloride extended-release tablets, USP are not indicated for use in pediatric population.