FDA.reportPublic FDA data

Application 761070

Type
BLA
Sponsor
ASTRAZENECA AB

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761070Fasenrabenralizumab351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FASENRABENRALIZUMABINJECTABLE;INJECTION30MG/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
FASENRABENRALIZUMABAstraZeneca Pharmaceuticals LPda6aca1a-19ed-44a4-abb7-696c7d58b7842026-05-13Warnings, Adverse reactionsExact identifier
application number: BLA761070
ndc (product): 0310-1830
ndc (product): 0310-1730

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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0310-1730FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1730FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1730FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1730FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1730FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1730FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1730FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1730FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1730FASENRABenralizumabAstraZeneca PharmaceuticaBLACurrent
0310-1830FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1830FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1830FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1830FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1830FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent
0310-1830FASENRABenralizumabAstraZeneca Pharmaceuticals LPBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85942SUPPL 2026-05-18
85920SUPPL 2026-05-15
79659SUPPL 2024-09-19
79652SUPPL 2024-09-18
78078SUPPL 2024-04-09
78082SUPPL 2024-04-08
60244SUPPL2019-10-04
60222SUPPL2019-10-04
50943ORIG2017-12-29
50424ORIG2017-11-15
50414ORIG2017-11-15
51890ORIG1900-01-01
51889ORIG1900-01-01
51888ORIG1900-01-01