Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Apotex Inc.
209429182
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
60505-2850Application Number
ANDA079013Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 8, 2023AlfuzosinActive
Code: 75046A1XTNClass: ACTIBQuantity: 10 mg in 1 1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
HYPROMELLOSE 2208 (4000 MPA.S)Inactive
Code: 39J80LT57TClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYVINYL ACETATE PHTHALATEInactive
Code: 58QVG85GW3Class: IACT