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FDA Approval

Icatibant

CompanyHikma Pharmaceuticals USA Inc. (DUNS: 118707839)

Effective Date

November 30, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Icatibant(30 mg in 3 mL)

Products (1)

Icatibant

NDC Product Code

24201-207

Application Number

ANDA211021

Marketing Category

ANDA (C73584)

Route of Administration

SUBCUTANEOUS

Effective Date

November 30, 2023

Ingredients

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACTQuantity: 1.92 mg in 3 mL

ACETIC ACIDInactive

Code: Q40Q9N063PClass: IACTQuantity: 3.96 mg in 3 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 22.35 mg in 3 mL

IcatibantActive

Code: 325O8467XKClass: ACTIMQuantity: 30 mg in 3 mL

WATERInactive

Code: 059QF0KO0RClass: IACT

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