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Opdivo

nivolumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Opdivo

Proper name

nivolumab

Licence type

351(a)

BLA number

125554

Applicant

Bristol-Myers Squibb Company

Center

CDER

Presentations

4

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
100MG/10ML (10MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	December 22, 2014
120MG/12ML (10MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	August 27, 2021
240MG/24ML (10MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	October 4, 2017
40MG/4ML (10MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	December 22, 2014

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	April 13, 1931

Sources for this page

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