Application 761429

Type
BLA
Sponsor
BRISTOL-MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OPDIVO QVANTIGNIVOLUMAB;HYALURONIDASE-NVHYINJECTABLE;INJECTION600MG;10000 UNITS PER 5ML(120MG/2000UNITS PER 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 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OPDIVO QVANTIGNIVOLUMAB AND HYALURONIDASE-NVHYE.R. Squibb & Sons, L.L.C.7f8c38fa-42f4-4387-9e8c-7a1c66855d8b2026-05-12Warnings, Adverse reactionsName fallback
brand name: OPDIVO QVANTIG

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84145ORIG 2025-11-13
80785ORIG 2024-12-30
80779ORIG 2024-12-30
80778ORIG 2024-12-30