ERWINASE
Approved
Approval ID
bd0f5322-a1d3-79c3-e053-2995a90acd70
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 15, 2021
Manufacturers
FDA
Porton Biopharma Limited
DUNS: 220514820
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
asparaginase
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81561-413
Product Classification
G
Generic Name
asparaginase
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMay 3, 2021
FDA Product Classification
INGREDIENTS (3)
ASPARAGINASE ERWINIA CHRYSANTHEMIActive
Quantity: 10000 [iU] in 1 mL
Code: D733ET3F9O
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
DEXTROSE MONOHYDRATEInactive
Quantity: 5 mg in 1 mL
Code: LX22YL083G
Classification: IACT