ADAKVEO
These highlights do not include all the information needed to use ADAKVEO safely and effectively. See full prescribing information for ADAKVEO. ADAKVEO (crizanlizumab-tmca) injection, for intravenous use Initial U.S. Approval: 2019
Approved
Approval ID
b2b7f8b4-fe9a-4a86-8129-9e43f99a20c6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 18, 2023
Manufacturers
FDA
Novartis Pharmaceuticals Corporation
DUNS: 002147023
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
crizanlizumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-0883
Application NumberBLA761128
Product Classification
M
Marketing Category
C73585
G
Generic Name
crizanlizumab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 15, 2019
FDA Product Classification
INGREDIENTS (6)
CRIZANLIZUMABActive
Quantity: 10 mg in 1 mL
Code: L7451S9126
Classification: ACTIB
SODIUM CITRATEInactive
Quantity: 5.053 mg in 1 mL
Code: 1Q73Q2JULR
Classification: IACT
SUCROSEInactive
Quantity: 75.33 mg in 1 mL
Code: C151H8M554
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.54 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.200 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT