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
NDC Product Code66658-234
Application NumberBLA103950
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 30, 2020
Generic Nameanakinra
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