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TheraCys

BCG Live

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

TheraCys

Proper name

BCG Live

Licence type

351(a)

BLA number

103943

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
81MG	For Injection	Intravesical	Vial	Rx	February 24, 2000

Sources for this page

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