Product Details for: TheraCys
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravesical
81MG
Vial
351(a)
TheraCys
Rx
Proper Name
BCG Live
BCG Live
BLA Number
103943
103943
Applicant
Sanofi Vaccines Canada Ltd.
Sanofi Vaccines Canada Ltd.
Original Approval Date
February 24, 2000
February 24, 2000
Date of First Licensure