FDA.reportPublic FDA data

Application 761069

Type
BLA
Sponsor
ASTRAZENECA UK LTD

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761069Imfinzidurvalumab351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMFINZIDURVALUMABINJECTABLE;INJECTION50MG/MLYesNo

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IMFINZIDURVALUMABAstraZeneca Pharmaceuticals LP8baba4ea-2855-42fa-9bd9-5a7548d4cec32026-08-31Warnings, Adverse reactionsExact identifier
application number: BLA761069
ndc (product): 0310-4500
ndc (product): 0310-4611

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0310-4500IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4500IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4500IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4500IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4500IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4500IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4500IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4500IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4500IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4500IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4500IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4500IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4500IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4500IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4500IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4500IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4611IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4611IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4611IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4611IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4611IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4611IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4611IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4611IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4611IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4611IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4611IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4611IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4611IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4611IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4611IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-4611IMFINZIDurvalumabAstraZeneca Pharmaceuticals LPBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84341SUPPL 2025-11-28
84340SUPPL 2025-11-28
84329SUPPL 2025-11-28
81900SUPPL 2025-04-09
81820SUPPL 2025-04-03
81778SUPPL 2025-03-31
81430SUPPL 2025-03-04
81396SUPPL 2025-03-03
80512SUPPL 2024-12-05
80508SUPPL 2024-12-05
79437SUPPL 2024-08-20
79430SUPPL 2024-08-16
79425SUPPL 2024-08-16
79228SUPPL 2024-07-29
79207SUPPL 2024-07-25
78816SUPPL 2024-06-18
78805SUPPL 2024-06-14
78252SUPPL 2024-04-25
78209SUPPL 2024-04-23
77183SUPPL 2024-01-04
77125SUPPL 2023-12-22
74551SUPPL 2023-06-20
74541SUPPL 2023-06-20
72621SUPPL2022-11-16
72619SUPPL2022-11-15
72611SUPPL2022-11-14
72605SUPPL2022-11-13
72604SUPPL2022-11-10
72498SUPPL2022-10-31
72470SUPPL2022-10-26
72453SUPPL2022-10-24
72014SUPPL2022-09-06
72013SUPPL2022-09-02
72012SUPPL2022-09-02
71059SUPPL2022-05-12
71050SUPPL2022-05-12
68124SUPPL2021-07-19
68123SUPPL2021-07-19
68115SUPPL2021-07-19
66355SUPPL2021-02-24
66354SUPPL2021-02-24
66319SUPPL2021-02-23
65291SUPPL2020-11-19
65290SUPPL2020-11-19
65289SUPPL2020-11-19
65275SUPPL2020-11-19
65274SUPPL2020-11-19
65273SUPPL2020-11-19
65272SUPPL2020-11-19
65271SUPPL2020-11-19
65270SUPPL2020-11-19
65211SUPPL2020-11-13
65210SUPPL2020-11-13
65191SUPPL2020-11-12
63457SUPPL2020-06-09
63452SUPPL2020-06-08
63451SUPPL2020-06-08
62358SUPPL2020-03-30
62355SUPPL2020-03-30
62354SUPPL2020-03-30
59398SUPPL2019-07-23
59388SUPPL2019-07-22
52697SUPPL2018-02-23
52669SUPPL2018-02-16
52668SUPPL2018-02-16
48707ORIG2017-06-13
48214ORIG2017-05-02
48172ORIG2017-05-01