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)Rx2026-06-01

Application Products#

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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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