Purple Book reference family · 351(a) biologic
BCG Live (TheraCys)
BCG Live is an FDA-licensed reference biologic from Sanofi Vaccines Canada Ltd..
351(a) biologicBLA 103943 Sanofi Vaccines Canada Ltd.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2000
Reference product
Originator biologic
351(a)BLA 103943
TheraCys BCG Live
Sanofi Vaccines Canada Ltd.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference BCG Live product.
26 yr 10 mo ago
BCG Live: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for BCG Live.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
