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FDA Approval

ICATIBANT

CompanyApotex Corp. (DUNS: 845263701)

Effective Date

February 29, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Icatibant(30 mg in 3 mL)

Registrants (1)

Nang Kuang Pharmaceutical Co. Ltd.

DUNS Number

656118783

Manufacturing Establishments (1)

Nang Kuang Pharmaceutical Co. Ltd.

Labeler

Apotex Corp.

Registrant

Nang Kuang Pharmaceutical Co. Ltd.

DUNS Number

656118783

Products (1)

ICATIBANT

NDC Product Code

60505-6214

Application Number

ANDA212081

Marketing Category

ANDA (C73584)

Route of Administration

SUBCUTANEOUS

Effective Date

February 29, 2024

Ingredients

sodium hydroxideInactive

Code: 55X04QC32IClass: IACT

IcatibantActive

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

acetic acidInactive

Code: Q40Q9N063PClass: IACT

sodium chlorideInactive

Code: 451W47IQ8XClass: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

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