Uroxatral
These highlights do not include all the information needed to use UROXATRAL safely and effectively. See full prescribing information for UROXATRAL. UROXATRAL (alfuzosin HCl) extended-release tablets Initial U.S. Approval: 2003
Approved
Approval ID
9fc7f119-f36b-44cf-945d-940160f3afe3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 18, 2021
Manufacturers
FDA
Concordia Pharmaceuticals Inc.
DUNS: 815240092
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Alfuzosin HCl
PRODUCT DETAILS
NDC Product Code59212-200
Application NumberNDA021287
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJanuary 31, 2019
Generic NameAlfuzosin HCl
INGREDIENTS (10)
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
alfuzosin hydrochlorideActive
Quantity: 10 mg in 1 1
Code: 75046A1XTN
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
ethylcellulose (100 mpa.s)Inactive
Code: 47MLB0F1MV
Classification: IACT
hydrogenated castor oilInactive
Code: ZF94AP8MEY
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT