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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761420
Company: CELLTRION INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AVTOZMA TOCILIZUMAB-ANOH 80MG/4ML(20MG/ML) INJECTABLE;INTRAVENOUS Prescription None No No
AVTOZMA TOCILIZUMAB-ANOH 200MG/10ML(20MG/ML) INJECTABLE;INTRAVENOUS Prescription None No No
AVTOZMA TOCILIZUMAB-ANOH 400MG/20ML(20MG/ML) INJECTABLE;INTRAVENOUS Prescription None No No
AVTOZMA TOCILIZUMAB-ANOH 162MG/0.9ML INJECTABLE;SUBCUTANEOUS 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
01/24/2025 ORIG-1 Approval N/A Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761420s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761420Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761420Orig1s000TOC.html
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/14/2026 SUPPL-5 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761420s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761420Orig1s005ltr.pdf
07/29/2025 SUPPL-1 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761420s001lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761420Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/14/2026 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761420s005lbl.pdf
07/29/2025 SUPPL-1 Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761420s001lbledt.pdf
01/24/2025 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761420s000lbl.pdf
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