ZYNYZ

ZYNYZ

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 556967347

Effective Date

November 10, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Retifanlimab(25 mg in 1 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

50881-006

Application Number

BLA761334

Marketing Category

BLA (C73585)

Route of Administration

INTRAVENOUS

Effective Date

November 10, 2023

Ingredients

SODIUM ACETATEInactive

Code: 4550K0SC9BClass: IACTQuantity: .95 mg in 1 mL

Code: 2Y3T5IF01ZClass: ACTIBQuantity: 25 mg in 1 mL

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACTQuantity: .1 mg in 1 mL

ACETIC ACIDInactive

Code: Q40Q9N063PClass: IACTQuantity: .18 mg in 1 mL

SUCROSEInactive

Code: C151H8M554Class: IACTQuantity: 90 mg in 1 mL

WATERInactive

Code: 059QF0KO0RClass: IACT