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
43353-746Application Number
ANDA079014Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
July 25, 2017AlfuzosinActive
Code: 75046A1XTNClass: ACTIBQuantity: 10 mg in 1 1
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
POVIDONESInactive
Code: FZ989GH94EClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT