Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
American Regent, Inc.
American Regent, Inc.
002033710
Vifor (International) Inc.
American Regent, Inc.
482603065
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Venofer
Product Details
NDC Product Code
0517-2340Application Number
NDA021135Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
June 1, 2022IronActive
Code: FZ7NYF5N8LClass: ACTIMQuantity: 20 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
Venofer
Product Details
NDC Product Code
0517-2325Application Number
NDA021135Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
June 1, 2022WATERInactive
Code: 059QF0KO0RClass: IACT
IronActive
Code: FZ7NYF5N8LClass: ACTIMQuantity: 20 mg in 1 mL
Venofer
Product Details
NDC Product Code
0517-2310Application Number
NDA021135Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
June 1, 2022WATERInactive
Code: 059QF0KO0RClass: IACT
IronActive
Code: FZ7NYF5N8LClass: ACTIMQuantity: 20 mg in 1 mL