Fusilev
These highlights do not include all the information needed to use Fusilev safely and effectively. See full prescribing information for Fusilev. Fusilev® (levoleucovorin) for injection, for intravenous use Initial U.S. Approval: 1952 (d,l-leucovorin)
Approved
Approval ID
2255268c-b703-42e5-a81a-0fb223a77fd6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 2, 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.
levoleucovorin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72893-009
Application NumberNDA020140
Product Classification
M
Marketing Category
C73594
G
Generic Name
levoleucovorin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 2, 2023
FDA Product Classification
INGREDIENTS (4)
MANNITOLInactive
Quantity: 50 mg in 5 mL
Code: 3OWL53L36A
Classification: IACT
LEVOLEUCOVORIN CALCIUMActive
Quantity: 50 mg in 5 mL
Code: 778XL6VBS8
Classification: ACTIM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT