ZYNYZ
These highlights do not include all the information needed to use ZYNYZ safely and effectively. See full prescribing information for . () injection, for intravenous use Initial U.S. Approval: 2023
Approved
Approval ID
109648d0-d30a-42fc-8273-39cb1540a751
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2023
Manufacturers
FDA
Incyte Corporation
DUNS: 556967347
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
retifanlimab-dlwr
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50881-006
Application NumberBLA761334
Product Classification
M
Marketing Category
C73585
G
Generic Name
retifanlimab-dlwr
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 10, 2023
FDA Product Classification
INGREDIENTS (6)
SODIUM ACETATEInactive
Quantity: .95 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
RETIFANLIMABActive
Quantity: 25 mg in 1 mL
Code: 2Y3T5IF01Z
Classification: ACTIB
POLYSORBATE 80Inactive
Quantity: .1 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
ACETIC ACIDInactive
Quantity: .18 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
SUCROSEInactive
Quantity: 90 mg in 1 mL
Code: C151H8M554
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT