Alfuzosin Hydrochloride
These highlights do not include all the information needed to use alfuzosin HCl extended-release tablets safely and effectively. See full prescribing information for alfuzosin HCl extended-release tablets. Alfuzosin Hydrochloride Extended-Release Tablets Initial U.S. Approval: 2003
Approved
Approval ID
30f97b8e-4486-4b5f-896a-d7dfa1e2e33a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 20, 2012
Manufacturers
FDA
Wockhardt Limited
DUNS: 650069115
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 Code55648-738
Application NumberANDA090221
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alfuzosin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 20, 2012
FDA Product Classification
INGREDIENTS (10)
ALFUZOSIN HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 75046A1XTN
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT