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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761417
Company: BEIGENE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TEVIMBRA TISLELIZUMAB-JSGR 100MG/10ML(10MG/ML) INJECTABLE;INTRAVENOUS Prescription None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/26/2024 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761417Orig1s000correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761417Orig1s000correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761417Orig1s000TOC.cfm

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/26/2024 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761417Orig1s000correctedlbl.pdf
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