An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 761381
Company: BRISTOL-MYERS SQUIBB

Medication Guide

Products on BLA 761381

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OPDIVO QVANTIG	NIVOLUMAB;HYALURONIDASE-NVHY	600MG;10000UNITS PER5ML(120MG/2000UNITS PER ML)	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761381

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/27/2024	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761381Orig1s000correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761381Orig1s000correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761381Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/23/2025	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761381s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761381Orig1s008ltr.pdf
11/24/2025	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761381s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761381Orig1s005ltr.pdf
10/27/2025	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761381s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761381Orig1s002ltr.pdf
10/27/2025	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761381s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761381Orig1s001ltr.pdf

Labels for BLA 761381

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/24/2025	SUPPL-5	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761381s005lbl.pdf
10/27/2025	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761381s002lbl.pdf
10/27/2025	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761381s001lbl.pdf
05/23/2025	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761381s008lbl.pdf
12/27/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761381Orig1s000correctedlbl.pdf

Top