Halaven
These highlights do not include all the information needed to use HALAVEN safely and effectively. See full prescribing information for HALAVEN. HALAVEN (eribulin mesylate) injection, for intravenous use Initial U.S. Approval: 2010
Approved
Approval ID
31ce4750-ded5-4a0b-95e9-f229fa6bc822
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 17, 2022
Manufacturers
FDA
Eisai Inc.
DUNS: 189246791
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
eribulin mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62856-389
Application NumberNDA201532
Product Classification
M
Marketing Category
C73594
G
Generic Name
eribulin mesylate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 17, 2023
FDA Product Classification
INGREDIENTS (5)
ERIBULIN MESYLATEActive
Quantity: 0.5 mg in 1 mL
Code: AV9U0660CW
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT