Alfuzosin Hydrochloride
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, USP for oral useInitial U.S. Approval: 2003
Approved
Approval ID
be2c5e2e-6435-4d0f-bf5c-79dbcab99ebb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43353-746
Application NumberANDA079014
Product Classification
M
Marketing Category
C73584
G
Generic Name
alfuzosin
Product Specifications
Route of AdministrationORAL
Effective DateJuly 25, 2017
FDA Product Classification
INGREDIENTS (5)
ALFUZOSIN HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 75046A1XTN
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT