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FDA Approval

Icatibant

CompanyTeva Pharmaceuticals USA, Inc. (DUNS: 001627975)

Effective Date

October 27, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Icatibant(10 mg in 1 mL)

Products (1)

Icatibant

NDC Product Code

0093-3066

Application Number

ANDA210118

Marketing Category

ANDA (C73584)

Route of Administration

SUBCUTANEOUS

Effective Date

October 27, 2022

Ingredients

IcatibantActive

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

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

ACETIC ACIDInactive

Code: Q40Q9N063PClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

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