Sodium Ferric Gluconate Complex in Sucrose

FDA Drug Profile — Sodium Ferric Gluconate Complex in Sucrose

Drug Details

Generic Name
Sodium Ferric Gluconate Complex in Sucrose
Brand Names
Sodium Ferric Gluconate Complex in Sucrose
Application Number
ANDA078215
Sponsor
Hikma Pharmaceuticals USA Inc.
NDC Codes
2
Dosage Forms
INJECTION
Routes
INTRAVENOUS
Active Ingredients
SODIUM FERRIC GLUCONATE COMPLEX

Indications and Usage

1 INDICATIONS AND USAGE Sodium ferric gluconate complex in sucrose injection is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. Sodium ferric gluconate complex in sucrose injection is an iron replacement product for treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. ( 1 )