Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
West Services and Solutions LLC
Amgen Inc
118935952
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Imlygic
Product Details
NDC Product Code
55513-079Application Number
BLA125518Marketing Category
BLA (C73585)Route of Administration
INTRALESIONALEffective Date
February 10, 2023Talimogene laherparepvecActive
Code: 07730V90L6Class: ACTIBQuantity: 100000000 [PFU] in 1 mL
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2TClass: IACTQuantity: 15.4 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Code: 5QWK665956Class: IACTQuantity: 2.44 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8.5 mg in 1 mL
SORBITOLInactive
Code: 506T60A25RClass: IACTQuantity: 20 mg in 1 mL
INOSITOLInactive
Code: 4L6452S749Class: IACTQuantity: 40 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
Imlygic
Product Details
NDC Product Code
55513-078Application Number
BLA125518Marketing Category
BLA (C73585)Route of Administration
INTRALESIONALEffective Date
February 10, 2023Talimogene laherparepvecActive
Code: 07730V90L6Class: ACTIBQuantity: 1000000 [PFU] in 1 mL
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2TClass: IACTQuantity: 15.4 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8.5 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Code: 5QWK665956Class: IACTQuantity: 2.44 mg in 1 mL
INOSITOLInactive
Code: 4L6452S749Class: IACTQuantity: 40 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACTQuantity: 20 mg in 1 mL