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Orthoclone OKT3

muromonab-CD3

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Orthoclone OKT3

Proper name

muromonab-CD3

Licence type

351(a)

BLA number

103463

Applicant

Centocor Ortho Biotech Products, L.P.

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
1MG/ML	Injection	Intravenous	Ampule	Disc	September 14, 1992

Sources for this page

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