Halaven
HALAVEN (eribulin mesylate) injection 0.5 mg/mL
Approved
Approval ID
8fc8fe1d-59fe-4e43-a95c-e7aa13422cd6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 22, 2023
Manufacturers
FDA
BSP Pharmaceuticals SpA
DUNS: 857007830
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 Code43624-002
Application NumberNDA201532
Product Classification
M
Marketing Category
C73594
G
Generic Name
eribulin mesylate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 22, 2023
FDA Product Classification
INGREDIENTS (3)
ERIBULIN MESYLATEActive
Quantity: 0.5 mg in 1 mL
Code: AV9U0660CW
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT