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FDA Approval

Icatibant

CompanyEugia US LLC (DUNS: 968961354)

Effective Date

August 16, 2023

Labeling Type

Human Prescription Drug Label

Active Ingredients

Icatibant(30 mg in 3 mL)

Manufacturing Establishments (2)

Auro Peptides Limited

Labeler

Eugia US LLC

DUNS Number

650804672

Eugia Pharma Specialities Limited

Labeler

Eugia US LLC

DUNS Number

650498244

Products (1)

Icatibant

NDC Product Code

55150-351

Application Number

ANDA213521

Marketing Category

ANDA (C73584)

Route of Administration

SUBCUTANEOUS

Effective Date

April 7, 2023

Ingredients

IcatibantActive

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

ACETIC ACIDInactive

Code: Q40Q9N063PClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

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