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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

NDC Product Code62856-389
Application NumberNDA201532
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateNovember 17, 2023
Generic Nameeribulin mesylate

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
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Halaven - FDA Approval | MedPath