Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
BSP Pharmaceuticals SpA
857007830
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
BSP Pharmaceuticals SpA
BSP Pharmaceuticals SpA
BSP Pharmaceuticals SpA
857007830
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Halaven
Product Details
NDC Product Code
43624-002Application Number
NDA201532Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
November 22, 2023EribulinActive
Code: AV9U0660CWClass: ACTIBQuantity: 0.5 mg in 1 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT