Alfuzosin Hydrochloride
ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. These highlights do not include all the information needed to use ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. ALFUZOSIN HYDROCHLORIDE extended-release tablets Initial U.S. Approval: 2003
Approved
Approval ID
074f9deb-0ace-4292-e063-6294a90aae92
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 9, 2023
Manufacturers
FDA
Golden State Medical Supply, Inc.
DUNS: 603184490
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Alfuzosin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51407-829
Application NumberANDA079013
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alfuzosin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2023
FDA Product Classification
INGREDIENTS (6)
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ACETATE PHTHALATEInactive
Code: 58QVG85GW3
Classification: IACT
ALFUZOSIN HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 75046A1XTN
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT