Yuflyma
These highlights do not include all the information needed to use YUFLYMA safely and effectively. See full prescribing information for YUFLYMA. YUFLYMA (adalimumab-aaty) injection, for subcutaneous use Initial U.S. Approval: 2023YUFLYMA (adalimumab-aaty) is biosimilar to HUMIRA (adalimumab).
Approved
Approval ID
526d626f-8c9f-496c-b838-00a73bb36383
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 2, 2024
Manufacturers
FDA
CELLTRION USA, Inc.
DUNS: 116587378
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
adalimumab
PRODUCT DETAILS
NDC Product Code72606-024
Application NumberBLA761219
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 1, 2023
Generic Nameadalimumab
INGREDIENTS (2)
adalimumabActive
Quantity: 20 mg in 0.2 mL
Code: FYS6T7F842
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
adalimumab
PRODUCT DETAILS
NDC Product Code72606-039
Application NumberBLA761219
Marketing CategoryC73585
Route of AdministrationN/A
Effective DateDecember 1, 2023
Generic Nameadalimumab
adalimumab
PRODUCT DETAILS
NDC Product Code72606-023
Application NumberBLA761219
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 1, 2023
Generic Nameadalimumab
INGREDIENTS (2)
adalimumabActive
Quantity: 80 mg in 0.8 mL
Code: FYS6T7F842
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
adalimumab
PRODUCT DETAILS
NDC Product Code72606-046
Application NumberBLA761219
Marketing CategoryC73585
Route of AdministrationN/A
Effective DateDecember 1, 2023
Generic Nameadalimumab
adalimumab
PRODUCT DETAILS
NDC Product Code72606-030
Application NumberBLA761219
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 1, 2023
Generic Nameadalimumab
INGREDIENTS (2)
adalimumabActive
Quantity: 40 mg in 0.4 mL
Code: FYS6T7F842
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT