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Vectibix

panitumumab

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Vectibix

Proper name

panitumumab

Licence type

351(a)

BLA number

125147

Applicant

Amgen Inc.

Center

CDER

Presentations

3

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/5ML (20MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	September 27, 2006
200MG/10ML (20MG/ML)	Injection	Intravenous	Single-Dose Vial	Disc	September 27, 2006
400MG/20ML (20MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	September 27, 2006

Sources for this page

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