YUSIMRY
These highlights do not include all the information needed to use YUSIMRY safely and effectively. See full prescribing information for YUSIMRY.YUSIMRY (adalimumab-aqvh) injection, for subcutaneous useInitial U.S. Approval: 2021
Approved
Approval ID
cd0e7af2-7704-49ce-bde9-f645294b6788
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2023
Manufacturers
FDA
Coherus BioSciences Inc
DUNS: 078502849
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
adalimumab-aqvh
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70114-210
Application NumberBLA761216
Product Classification
M
Marketing Category
C73585
G
Generic Name
adalimumab-aqvh
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 28, 2023
FDA Product Classification
INGREDIENTS (7)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ADALIMUMABActive
Quantity: 40 mg in 0.8 mL
Code: FYS6T7F842
Classification: ACTIB
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6P
Classification: IACT
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
adalimumab-aqvh
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70114-220
Application NumberBLA761216
Product Classification
M
Marketing Category
C73585
G
Generic Name
adalimumab-aqvh
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateFebruary 28, 2023
FDA Product Classification
INGREDIENTS (7)
ADALIMUMABActive
Quantity: 40 mg in 0.8 mL
Code: FYS6T7F842
Classification: ACTIB
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6P
Classification: IACT
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT