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Opdivo Qvantig

nivolumab and hyaluronidase-nvhy

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Opdivo Qvantig

Proper name

nivolumab and hyaluronidase-nvhy

Licence type

351(a)

BLA number

761381

Applicant

Bristol-Myers Squibb Company

Center

CDER

Presentations

First licensure

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Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
300MG/2.5ML;5,000UNITS/2.5ML (120MG/2,000UNITS/ML)	Injection	Subcutaneous	Single-Dose Vial	Rx	November 24, 2025
600MG/5ML;10,000UNITS/5ML (120MG/2,000UNITS/ML)	Injection	Subcutaneous	Single-Dose Vial	Rx	December 27, 2024

Purple Book	FDA	Licence type, presentations, reference product, exclusivity