Campath
These highlights do not include all the information needed to use CAMPATH safely and effectively. See full prescribing information for CAMPATH. CAMPATH (alemtuzumab) injection, for intravenous useInitial U.S. Approval: 2001
Approved
Approval ID
4f5f7255-7abc-4328-bd1a-ceaf139ef3e0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 3, 2023
Manufacturers
FDA
Genzyme Corporation
DUNS: 025322157
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ALEMTUZUMAB
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58468-0357
Application NumberBLA103948
Product Classification
M
Marketing Category
C73585
G
Generic Name
ALEMTUZUMAB
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 1, 2023
FDA Product Classification
INGREDIENTS (7)
ALEMTUZUMABActive
Quantity: 30 mg in 1 mL
Code: 3A189DH42V
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
MONOBASIC POTASSIUM PHOSPHATEInactive
Quantity: 0.2 mg in 1 mL
Code: 4J9FJ0HL51
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.1 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
POTASSIUM CHLORIDEInactive
Quantity: 0.2 mg in 1 mL
Code: 660YQ98I10
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Quantity: 1.44 mg in 1 mL
Code: GR686LBA74
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.0187 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT