Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
IV STABILIZER
Product Details
NDC Product Code
73380-4715Application Number
BLA761104Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUSEffective Date
August 31, 2020Polysorbate 80Active
Code: 6OZP39ZG8HClass: ACTIBQuantity: 6.5 mg in 1 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 0.7 mg in 1 mL
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACTQuantity: 6.4 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACTQuantity: 1 mg in 1 mL
LUMOXITI
Product Details
NDC Product Code
73380-4700Application Number
BLA761104Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUSEffective Date
August 31, 2020Moxetumomab pasudotoxActive
Code: 2NDX4B6N8FClass: ACTIBQuantity: 1 mg in 1 mL
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RNClass: IACTQuantity: 3.4 mg in 1 mL
GLYCINEInactive
Code: TE7660XO1CClass: IACTQuantity: 80 mg in 1 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACTQuantity: 0.2 mg in 1 mL
SUCROSEInactive
Code: C151H8M554Class: IACTQuantity: 40 mg in 1 mL