Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
AstraZeneca PLC
230790719
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LUMOXITI
Product Details
NDC Product Code
0310-4700Application Number
BLA761104Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUSEffective Date
February 8, 2022Moxetumomab pasudotoxActive
Code: 2NDX4B6N8FClass: ACTIBQuantity: 1 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
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RNClass: IACTQuantity: 3.4 mg in 1 mL
IV Solution Stabilizer
Product Details
NDC Product Code
0310-4715Application Number
BLA761104Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUSEffective Date
February 8, 2022Polysorbate 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: 1.0 mg in 1 mL