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FDA Approval

Icatibant

CompanyFresenius Kabi USA, LLC (DUNS: 608775388)

Effective Date

November 8, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Icatibant(10 mg in 1 mL)

Manufacturing Establishments (1)

Fresenius Kabi Austria

Labeler

Fresenius Kabi USA, LLC

DUNS Number

300206604

Products (1)

Icatibant

NDC Product Code

63323-574

Application Number

ANDA208317

Marketing Category

ANDA (C73584)

Route of Administration

SUBCUTANEOUS

Effective Date

August 28, 2019

Ingredients

IcatibantActive

Code: 325O8467XKClass: ACTIMQuantity: 10 mg in 1 mL

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

ACETIC ACIDInactive

Code: Q40Q9N063PClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

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