asparlas
These highlights do not include all the information needed to use ASPARLAS safely and effectively. See full prescribing information for ASPARLAS. ASPARLAS (calaspargase pegol-mknl) injection, for intravenous use Initial U.S. Approval: 2018
Approved
Approval ID
6585bd0d-bd78-4341-9e87-0f7664821f05
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2023
Manufacturers
FDA
Servier Pharmaceuticals LLC
DUNS: 116608503
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
calaspargase pegol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72694-515
Application NumberBLA761102
Product Classification
M
Marketing Category
C73585
G
Generic Name
calaspargase pegol
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (5)
CALASPARGASE PEGOLActive
Quantity: 750 U in 1 mL
Code: T9FVH03HMZ
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Code: 5QWK665956
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT