ICATIBANT
These highlights do not include all the information needed to use ICATIBANT INJECTION safely and effectively. See full prescribing information for ICATIBANT INJECTION.ICATIBANT injection, for subcutaneous useInitial U.S. Approval: 2011
Approved
Approval ID
39ecd008-37af-4105-84a0-c0cb98b8d0ec
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 29, 2024
Manufacturers
FDA
Apotex Corp.
DUNS: 845263701
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
icatibant acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-6214
Application NumberANDA212081
Product Classification
M
Marketing Category
C73584
G
Generic Name
icatibant acetate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 29, 2024
FDA Product Classification
INGREDIENTS (5)
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
icatibant acetateActive
Quantity: 30 mg in 3 mL
Code: 325O8467XK
Classification: ACTIM
acetic acidInactive
Code: Q40Q9N063P
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT