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Mycobax

BCG Vaccine

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Mycobax

Proper name

BCG Vaccine

Licence type

351(a)

BLA number

103942

Applicant

Sanofi Vaccines Canada Ltd.

Center

CBER

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
1.5MG	For Injection	Intradermal	Multi-Dose Vial	Rx	February 24, 2000

Sources for this page

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