FDA.reportPublic FDA data

Application 761244

Type
BLA
Sponsor
BOEHRINGER INGELHEIM PHARMACEUTICALS INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761244Spevigospesolimab-sbzo351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SPEVIGOSPESOLIMAB-SBZOINJECTABLE;INTRAVENOUS900MGNoNo

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPEVIGOSPESOLIMAB-SBZOBoehringer Ingelheim Pharmaceuticals, Inc.41a481ee-3062-45d1-aed5-17e8b105634d2026-04-08Warnings, Adverse reactionsExact identifier
application number: BLA761244
ndc (product): 0597-0035
SPEVIGOSPESOLIMABLEO Pharma Inc.78a4f7eb-8d34-4467-8d40-74ed243238062026-03-16Warnings, Adverse reactionsExact identifier
application number: BLA761244

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0035SPEVIGOspesolimab-sbzoBoehringer Ingelheim Pharmaceuticals, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83877SUPPL 2025-10-23
83866SUPPL 2025-10-22
83865SUPPL 2025-10-22
82395SUPPL 2025-06-02
82353SUPPL 2025-05-29
82352SUPPL 2025-05-29
77871SUPPL 2024-03-19
77865SUPPL 2024-03-19
72203ORIG2022-09-30
72009ORIG2022-09-02
72008ORIG2022-09-02
72001ORIG2022-09-02