Registrants (1)
Fresenius Medical Care North America
958291411
Products (3)
Delflex
46163-212
NDA020171
NDA (C73594)
INTRAPERITONEAL
March 24, 2025
WATERInactive
Code: 059QF0KO0RClass: IACT
GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 4.25 g in 100 mL
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 538 mg in 100 mL
Magnesium chlorideActive
Code: 02F3473H9OClass: ACTIBQuantity: 5.08 mg in 100 mL
Lactic acidActive
Code: TU7HW0W0QTClass: ACTIBQuantity: 448 mg in 100 mL
Calcium chlorideActive
Code: M4I0D6VV5MClass: ACTIBQuantity: 18.4 mg in 100 mL
Delflex
46163-206
NDA020171
NDA (C73594)
INTRAPERITONEAL
March 24, 2025
WATERInactive
Code: 059QF0KO0RClass: IACT
GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 1.5 g in 100 mL
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 538 mg in 100 mL
Lactic acidActive
Code: TU7HW0W0QTClass: ACTIBQuantity: 448 mg in 100 mL
Calcium chlorideActive
Code: M4I0D6VV5MClass: ACTIBQuantity: 18.4 mg in 100 mL
Magnesium chlorideActive
Code: 02F3473H9OClass: ACTIBQuantity: 5.08 mg in 100 mL
Delflex
46163-209
NDA020171
NDA (C73594)
INTRAPERITONEAL
March 24, 2025
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 538 mg in 100 mL
Lactic acidActive
Code: TU7HW0W0QTClass: ACTIBQuantity: 448 mg in 100 mL
Calcium chlorideActive
Code: M4I0D6VV5MClass: ACTIBQuantity: 18.4 mg in 100 mL
Magnesium chlorideActive
Code: 02F3473H9OClass: ACTIBQuantity: 5.08 mg in 100 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 2.5 g in 100 mL