APPLICATION
BLA761417
TYPE
BLA
ORIGINAL APPROVAL
2024-12-26
LATEST ACTION
2024-12-26
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TEVIMBRAPrescription
TISLELIZUMAB-JSGR 100MG/10ML(10MG/ML) · INJECTABLE · INTRAVENOUS
Approval history
2024-12-26Type 9 - New indication submitted as distinct BLA, consolidated · Original · standard — Label ↗AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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