MedPath
FDA Approval

Alfuzosin Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Camber Pharmaceuticals
DUNS: 826774775
Effective Date
January 18, 2012
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Alfuzosin(10 mg in 1 1)

Manufacturing Establishments1

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

Invagen Pharmaceuticals

Camber Pharmaceuticals

165104469

Products1

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

Alfuzosin Hydrochloride extended release

Product Details

NDC Product Code
31722-302
Application Number
ANDA090284
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
January 18, 2012
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
GUAR GUMInactive
Code: E89I1637KEClass: IACT
AlfuzosinActive
Code: 75046A1XTNClass: ACTIBQuantity: 10 mg in 1 1
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
© Copyright 2025. All Rights Reserved by MedPath