Anthim
These highlights do not include all the information needed to use ANTHIM safely and effectively. See full prescribing information for ANTHIM. ANTHIM (obiltoxaximab) injection, for intravenous use Initial U.S. Approval: 2016
Approved
Approval ID
39ad8799-00a4-4fc8-9852-c0536350c474
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2023
Manufacturers
FDA
Elusys Therapeutics, Inc.
DUNS: 083819511
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
obiltoxaximab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69604-204
Application NumberBLA125509
Product Classification
M
Marketing Category
C73585
G
Generic Name
obiltoxaximab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 14, 2022
FDA Product Classification
INGREDIENTS (1)
OBILTOXAXIMABActive
Quantity: 100 mg in 1 mL
Code: 29Z5DNL48C
Classification: ACTIB