Adalimumab
These highlights do not include all the information needed to use ADALIMUMAB-AATY safely and effectively. See full prescribing information for ADALIMUMAB-AATY. ADALIMUMAB-AATY injection, for subcutaneous use Initial U.S. Approval: 2023This product is YUFLYMA (adalimumab-aaty). YUFLYMA (adalimumab-aaty) is biosimilar* to HUMIRA (adalimumab).
Approved
Approval ID
c44365e9-d470-4e35-978d-8565a9e3471e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2023
Manufacturers
FDA
CELLTRION USA, Inc.
DUNS: 116587378
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
adalimumab-aaty
PRODUCT DETAILS
NDC Product Code72606-040
Application NumberBLA761219
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 8, 2023
Generic Nameadalimumab-aaty
INGREDIENTS (2)
adalimumabActive
Quantity: 80 mg in 0.8 mL
Code: FYS6T7F842
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
adalimumab-aaty
PRODUCT DETAILS
NDC Product Code72606-022
Application NumberBLA761219
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 8, 2023
Generic Nameadalimumab-aaty
INGREDIENTS (2)
adalimumabActive
Quantity: 40 mg in 0.4 mL
Code: FYS6T7F842
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
adalimumab-aaty
PRODUCT DETAILS
NDC Product Code72606-041
Application NumberBLA761219
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 8, 2023
Generic Nameadalimumab-aaty
INGREDIENTS (2)
WaterInactive
Code: 059QF0KO0R
Classification: IACT
adalimumabActive
Quantity: 20 mg in 0.2 mL
Code: FYS6T7F842
Classification: ACTIB