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 Initial U.S. Approval: 2003
Approved
Approval ID
0feb7a22-7416-4502-bf6e-6341782d11ab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 5, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6329
Application NumberANDA079013
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alfuzosin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 27, 2012
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57T
Classification: IACT
ALFUZOSIN HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 75046A1XTN
Classification: ACTIB
POLYVINYL ACETATE PHTHALATEInactive
Code: 58QVG85GW3
Classification: IACT