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Libtayo

cemiplimab-rwlc

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Libtayo

Proper name

cemiplimab-rwlc

Licence type

351(a)

BLA number

761097

Applicant

Regeneron Pharmaceuticals, Inc.

Center

CDER

Presentations

1

First licensure

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Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
350MG/7ML (50MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	September 28, 2018

Sources for this page

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