Enspryng
These highlights do not include all the information needed to use ENSPRYNG safely and effectively. See full prescribing information for ENSPRYNG. ENSPRYNG (satralizumab-mwge) injection, for subcutaneous use Initial U.S. Approval: 2020
Approved
Approval ID
64c156a4-9bad-4d45-a294-0733c141f47b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 12, 2023
Manufacturers
FDA
Genentech Inc.
DUNS: 080129000
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Satralizumab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50242-007
Application NumberBLA761149
Product Classification
M
Marketing Category
C73585
G
Generic Name
Satralizumab
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 12, 2023
FDA Product Classification
INGREDIENTS (6)
SATRALIZUMABActive
Quantity: 120 mg in 1 mL
Code: YB18NF020M
Classification: ACTIB
HISTIDINEInactive
Quantity: 3.1 mg in 1 mL
Code: 4QD397987E
Classification: IACT
ASPARTIC ACIDInactive
Code: 30KYC7MIAI
Classification: IACT
ARGININEInactive
Quantity: 26.1 mg in 1 mL
Code: 94ZLA3W45F
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLOXAMER 188Inactive
Quantity: 0.5 mg in 1 mL
Code: LQA7B6G8JG
Classification: IACT