Beleodaq
These highlights do not include all the information needed to use BELEODAQ safely and effectively. See full prescribing information for BELEODAQ. BELEODAQ® (belinostat) for injection, for intravenous use Initial U.S. Approval: 2014
Approved
Approval ID
2e8ef36b-71fa-4492-a16f-577d5f7d111d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 15, 2023
Manufacturers
FDA
Acrotech Biopharma Inc
DUNS: 116965616
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Belinostat
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72893-002
Application NumberNDA206256
Product Classification
M
Marketing Category
C73594
G
Generic Name
Belinostat
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMay 15, 2023
FDA Product Classification
INGREDIENTS (2)
ARGININEInactive
Quantity: 1000 mg in 10 mL
Code: 94ZLA3W45F
Classification: IACT
BELINOSTATActive
Quantity: 500 mg in 10 mL
Code: F4H96P17NZ
Classification: ACTIB