HADLIMA
These highlights do not include all the information needed to use HADLIMA safely and effectively. See full prescribing information for HADLIMA. Initial U.S. Approval: 2019 HADLIMA (adalimumab-bwwd) is biosimilar* to HUMIRA (adalimumab)
Approved
Approval ID
ef25af7e-6267-409a-8d68-de51eb48812a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 2, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
adalimumab-bwwd
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-6706
Application NumberBLA761059
Product Classification
M
Marketing Category
C73585
G
Generic Name
adalimumab-bwwd
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 25, 2022
FDA Product Classification
INGREDIENTS (7)
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
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
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT