Home Applications 761381 Application 761381
Type BLA
Sponsor BRISTOL-MYERS SQUIBB Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761381 Opdivo Qvantig nivolumab and hyaluronidase-nvhy 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OPDIVO QVANTIG NIVOLUMAB;HYALURONIDASE-NVHY INJECTABLE;SUBCUTANEOUS 600MG;10000UNITS PER5ML(120MG/2000UNITS PER ML) No No
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Matched openFDA labels page 1 of 1 ยท 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join OPDIVO QVANTIG NIVOLUMAB AND HYALURONIDASE-NVHY E.R. Squibb & Sons, L.L.C. 7f8c38fa-42f4-4387-9e8c-7a1c66855d8b 2026-05-12 Warnings, Adverse reactions Exact identifier application number: BLA761381
Documents# Document, Submission type, Date table Document Submission type Date 85950 SUPPL 2026-05-18 85949 SUPPL 2026-05-18 85909 SUPPL 2026-05-13 84313 SUPPL 2025-11-25 84312 SUPPL 2025-11-25 84307 SUPPL 2025-11-25 84144 ORIG 2025-11-13 84014 SUPPL 2025-10-31 83959 SUPPL 2025-10-28 83942 SUPPL 2025-10-28 83941 SUPPL 2025-10-28 80780 ORIG 2025-06-13 82399 SUPPL 2025-06-02 82337 SUPPL 2025-05-28 80807 ORIG 2025-01-03