Kineret
These highlights do not include all the information needed to use KINERET safely and effectively. See full prescribing information for KINERET. KINERET® (anakinra) injection, for subcutaneous useInitial U.S. Approval: 2001
Approved
Approval ID
d9d74915-6606-4570-9c52-c4001d3177de
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 30, 2020
Manufacturers
FDA
Swedish Orphan Biovitrum AB (publ)
DUNS: 354010589
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
anakinra
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66658-234
Application NumberBLA103950
Product Classification
M
Marketing Category
C73585
G
Generic Name
anakinra
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 30, 2020
FDA Product Classification
INGREDIENTS (6)
anhydrous citric acidInactive
Quantity: 1.29 mg in 0.67 mL
Code: XF417D3PSL
Classification: IACT
anakinraActive
Quantity: 100 mg in 0.67 mL
Code: 9013DUQ28K
Classification: ACTIB
sodium chlorideInactive
Quantity: 5.48 mg in 0.67 mL
Code: 451W47IQ8X
Classification: IACT
edetate disodiumInactive
Quantity: 0.12 mg in 0.67 mL
Code: 7FLD91C86K
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
polysorbate 80Inactive
Quantity: 0.70 mg in 0.67 mL
Code: 6OZP39ZG8H
Classification: IACT