Rylaze
These highlights do not include all the information needed to use RYLAZE safely and effectively. See full prescribing information for RYLAZE. RYLAZE (asparaginase erwinia chrysanthemi (recombinant)-rywn) injection, for intramuscular useInitial U.S. Approval: 2021
Approved
Approval ID
857e53aa-1098-4dad-b654-0276cdd43e03
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 18, 2022
Manufacturers
FDA
Jazz Pharmaceuticals, Inc.
DUNS: 135926363
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
asparaginase erwinia chrysanthemi (recombinant)-rywn
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68727-900
Application NumberBLA761179
Product Classification
M
Marketing Category
C73585
G
Generic Name
asparaginase erwinia chrysanthemi (recombinant)-rywn
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJune 30, 2021
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Quantity: 50 mmol in 1 mL
Code: 451W47IQ8X
Classification: IACT
ASPARAGINASEActive
Quantity: 20 mg in 1 mL
Code: G4FQ3CKY5R
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 8.5 mmol in 1 mL
Code: 593YOG76RN
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.2 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
TREHALOSE DIHYDRATEInactive
Quantity: 170 mmol in 1 mL
Code: 7YIN7J07X4
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 11.6 mmol in 1 mL
Code: 22ADO53M6F
Classification: IACT