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.
Approved
Approval ID
790fe381-4a83-402e-b6c0-2ecde9cac7a7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 19, 2017
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
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 Code43353-945
Application NumberANDA090284
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alfuzosin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 22, 2014
FDA Product Classification
INGREDIENTS (6)
GUAR GUMInactive
Code: E89I1637KE
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ALFUZOSIN HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 75046A1XTN
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT