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FDA Approval

YERVOY

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

FDA Approval Summary

Company
Effective Date
February 15, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ipilimumab(5 mg in 1 mL)

Products2

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

YERVOY

Product Details

NDC Product Code
0003-2328
Application Number
BLA125377
Marketing Category
BLA (C73585)
Route of Administration
INTRAVENOUS
Effective Date
March 19, 2015
Code: 6T8C155666Class: ACTIBQuantity: 5 mg in 1 mL
TROMETHAMINE HYDROCHLORIDEInactive
Code: 383V75M34EClass: IACTQuantity: 3.15 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 5.85 mg in 1 mL
MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 10 mg in 1 mL
PENTETIC ACIDInactive
Code: 7A314HQM0IClass: IACTQuantity: 0.04 mg in 1 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACTQuantity: 0.1 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT

YERVOY

Product Details

NDC Product Code
0003-2327
Application Number
BLA125377
Marketing Category
BLA (C73585)
Route of Administration
INTRAVENOUS
Effective Date
March 19, 2015
Code: 6T8C155666Class: ACTIBQuantity: 5 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 5.85 mg in 1 mL
TROMETHAMINE HYDROCHLORIDEInactive
Code: 383V75M34EClass: IACTQuantity: 3.15 mg in 1 mL
MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 10 mg in 1 mL
PENTETIC ACIDInactive
Code: 7A314HQM0IClass: IACTQuantity: 0.04 mg in 1 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACTQuantity: 0.1 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
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