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Keytruda

pembrolizumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Keytruda

Proper name

pembrolizumab

Licence type

351(a)

BLA number

125514

Applicant

MSD International Business GmbH

Center

CDER

Presentations

2

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/4ML (25MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	January 15, 2015
50MG	For Injection	Intravenous	Single-Dose Vial	Disc	September 4, 2014

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	January 25, 1931

Sources for this page

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