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Opdualag

nivolumab and relatlimab-rmbw

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Opdualag

Proper name

nivolumab and relatlimab-rmbw

Licence type

351(a)

BLA number

761234

Applicant

Bristol-Myers Squibb Company

Center

CDER

Presentations

First licensure

—

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
240MG, 80MG/20ML (12MG, 4MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	March 18, 2022

Source: Purple Book

Kind	Expires
Orphan exclusivity	March 18, 2029

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