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FDA Approval

ICATIBANT

CompanyCipla USA Inc. (DUNS: 078719707)

Effective Date

September 7, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Icatibant(30 mg in 3 mL)

Registrants (1)

DUNS Number

078719707

Manufacturing Establishments (2)

BCN Peptides SA

Labeler

Cipla USA Inc.

Registrant

Cipla USA Inc.

DUNS Number

468203687

GLAND PHARMA LIMITED

Labeler

Cipla USA Inc.

Registrant

Cipla USA Inc.

DUNS Number

918601238

Products (1)

ICATIBANT

NDC Product Code

69097-664

Application Number

ANDA212446

Marketing Category

ANDA (C73584)

Route of Administration

SUBCUTANEOUS

Effective Date

May 31, 2023

Ingredients

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

SODIUM HYDROXIDEInactive

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

WATERInactive

Code: 059QF0KO0RClass: IACT

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