Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aphena Pharma Solutions - Tennessee, LLC
Aphena Pharma Solutions - Tennessee, LLC
128385585
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Alfuzosin hydrochloride
Product Details
NDC Product Code
43353-945Application Number
ANDA090284Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 22, 2014GUAR GUMInactive
Code: E89I1637KEClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
AlfuzosinActive
Code: 75046A1XTNClass: ACTIBQuantity: 10 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT