MedPath
FDA Approval

Icatibant

January 28, 2021

Human Prescription Drug Label

Icatibant(30 mg in 3 mL)

Products (1)

Icatibant

71225-114

ANDA211501

ANDA (C73584)

SUBCUTANEOUS

January 28, 2021

SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACTQuantity: 1.92 mg in 3 mL
IcatibantActive
Code: 325O8467XKClass: ACTIMQuantity: 30 mg in 3 mL
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACTQuantity: 3.96 mg in 3 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 22.35 mg in 3 mL
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