Alfuzosin Hydrochloride

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Sun Pharmaceutical Industries, Inc.

DUNS Number

725959238

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

47335-956

Application Number

ANDA079057

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 19, 2024

Ingredients

DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive

Code: 905HNO1SIHClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

Code: 75046A1XTNClass: ACTIBQuantity: 10 mg in 1 1

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WOClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT