Alfuzosin Hydrochloride
These highlights do not include all the information needed to use alfuzosin hydrochloride safely and effectively. See full prescribing information for alfuzosin hydrochloride extended-release tablets. Alfuzosin Hydrochloride Extended-Release TabletsInitial U.S. Approval: 2003
Approved
Approval ID
94458f26-9269-4fbc-80db-adc43b1fc62f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 14, 2013
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
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
NDC Product Code33261-994
Application NumberANDA079057
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 14, 2013
Generic NameAlfuzosin Hydrochloride
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ALFUZOSIN HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 75046A1XTN
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT