MedPath
FDA Approval

DELFLEX

October 19, 2023

HUMAN PRESCRIPTION DRUG LABEL

Glucose(1.5 g in 100 mL)
Lactic acid(448 mg in 100 mL)
Calcium chloride(18.4 mg in 100 mL)
Magnesium chloride(5.08 mg in 100 mL)
Sodium chloride(538 mg in 100 mL)

Products (3)

DELFLEX

49230-206

NDA020171

NDA (C73594)

INTRAPERITONEAL

October 19, 2023

WATERInactive
Code: 059QF0KO0RClass: IACT
GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 1.5 g in 100 mL
Code: TU7HW0W0QTClass: ACTIBQuantity: 448 mg in 100 mL
Code: M4I0D6VV5MClass: ACTIBQuantity: 18.4 mg in 100 mL
Code: 02F3473H9OClass: ACTIBQuantity: 5.08 mg in 100 mL
Code: 451W47IQ8XClass: ACTIBQuantity: 538 mg in 100 mL

DELFLEX

49230-209

NDA020171

NDA (C73594)

INTRAPERITONEAL

October 19, 2023

Code: 451W47IQ8XClass: ACTIBQuantity: 538 mg in 100 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: TU7HW0W0QTClass: ACTIBQuantity: 448 mg in 100 mL
Code: M4I0D6VV5MClass: ACTIBQuantity: 18.4 mg in 100 mL
Code: 02F3473H9OClass: ACTIBQuantity: 5.08 mg in 100 mL
GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 2.5 g in 100 mL

DELFLEX

49230-212

NDA020171

NDA (C73594)

INTRAPERITONEAL

October 19, 2023

Code: 451W47IQ8XClass: ACTIBQuantity: 538 mg in 100 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: TU7HW0W0QTClass: ACTIBQuantity: 448 mg in 100 mL
Code: M4I0D6VV5MClass: ACTIBQuantity: 18.4 mg in 100 mL
Code: 02F3473H9OClass: ACTIBQuantity: 5.08 mg in 100 mL
GlucoseActive
Code: LX22YL083GClass: ACTIBQuantity: 4.25 g in 100 mL
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