Adbry
These highlights do not include all the information needed to use ADBRY safely and effectively. See full prescribing information for ADBRY. ADBRY (tralokinumab-ldrm) injection, for subcutaneous use Initial U.S. Approval: 2021
Approved
Approval ID
d8020b69-3001-44e2-9b5d-5f93d9aaf6e1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2023
Manufacturers
FDA
LEO Pharma Inc.
DUNS: 832692615
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tralokinumab-ldrm
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50222-346
Application NumberBLA761180
Product Classification
M
Marketing Category
C73585
G
Generic Name
tralokinumab-ldrm
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (6)
TRALOKINUMABActive
Quantity: 150 mg in 1 mL
Code: GK1LYB375A
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
ACETIC ACIDInactive
Quantity: 0.3 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT