# OPDIVO QVANTIG — FDA application BLA761381

Informational only - not investment advice.

Application BLA761381 · type BLA · FDA status: approved · original approval 2024-12-27

Listed sponsor: BRISTOL-MYERS SQUIBB · [BMY company profile](/company/BMY/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | OPDIVO QVANTIG | NIVOLUMAB;HYALURONIDASE-NVHY | INJECTABLE | SUBCUTANEOUS | 600MG;10000UNITS PER5ML(120MG/2000UNITS PER ML) | Prescription | not listed | not listed |

## Orange Book patent and exclusivity listings

Patent/exclusivity listings: not applicable — the FDA Orange Book covers NDA and ANDA small-molecule applications, not BLA biologics.

## Compound cross-links

- HYALURONIDASE (HUMAN RECOMBINANT) · UNII 743QUY4VD8 · no lmmol compound match
- NIVOLUMAB · UNII 31YO63LBSN · no lmmol compound match

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/BMY/)
- [FDA-approved application index](/drug/)
- [Large-cap biopharma](/compare/pharma/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:BLA761381. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.