FDA.reportPublic FDA data

Application 761224

Type
BLA
Sponsor
ASTRAZENECA AB

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761224Tezspiretezepelumab-ekko351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEZSPIRETEZEPELUMAB-EKKOSOLUTION;SUBCUTANEOUS210MG/1.91ML(110MG/ML)NoNo

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
TEZSPIRETEZEPELUMAB-EKKOAmgen Inc60f0aa03-ad25-4d48-80ce-7fcfa76f325f2025-10-17Warnings, Adverse reactionsExact identifier
application number: BLA761224
ndc (product): 55513-100
ndc (product): 55513-112

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55513-100TEZSPIREtezepelumab-ekkoAmgen, IncBLACurrent
55513-100TEZSPIREtezepelumab-ekkoAmgen, IncBLACurrent
55513-112TEZSPIREtezepelumab-ekkoAmgen, IncBLACurrent
55513-112TEZSPIREtezepelumab-ekkoAmgen, IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83860SUPPL 2025-10-21
83817SUPPL 2025-10-20
74403SUPPL 2023-05-30
74399SUPPL 2023-05-30
73445SUPPL 2023-02-09
73366SUPPL 2023-02-02
69865ORIG2022-01-13
69726ORIG2021-12-21
69627ORIG2021-12-17