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.
IMFINZI
Product Details
NDC Product Code
0310-4500Application Number
BLA761069Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUSEffective Date
June 16, 2023HISTIDINEInactive
Code: 4QD397987EClass: IACTQuantity: 4.8 mg in 2.4 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACTQuantity: 0.5 mg in 2.4 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
DurvalumabActive
Code: 28X28X9OKVClass: ACTIBQuantity: 120 mg in 2.4 mL
TREHALOSE DIHYDRATEInactive
Code: 7YIN7J07X4Class: IACTQuantity: 250 mg in 2.4 mL
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6PClass: IACTQuantity: 6.5 mg in 2.4 mL
IMFINZI
Product Details
NDC Product Code
0310-4611Application Number
BLA761069Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUSEffective Date
June 16, 2023DurvalumabActive
Code: 28X28X9OKVClass: ACTIBQuantity: 500 mg in 10 mL
HISTIDINEInactive
Code: 4QD397987EClass: IACTQuantity: 20 mg in 10 mL
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6PClass: IACTQuantity: 27 mg in 10 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACTQuantity: 2 mg in 10 mL
TREHALOSE DIHYDRATEInactive
Code: 7YIN7J07X4Class: IACTQuantity: 1040 mg in 10 mL
WATERInactive
Code: 059QF0KO0RClass: IACT