← FDA DRUG APPROVALS

FDA BLA · BLA761420

AVTOZMA

tocilizumab

Sponsor: CELLTRION INC

APPLICATION
BLA761420
TYPE
BLA
ORIGINAL APPROVAL
2025-01-24
LATEST ACTION
2026-01-14
ROUTE
INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

AVTOZMAPrescription
TOCILIZUMAB-ANOH 400MG/20ML(20MG/ML) · INJECTABLE · INTRAVENOUS
AVTOZMAPrescription
TOCILIZUMAB-ANOH 80MG/4ML(20MG/ML) · INJECTABLE · INTRAVENOUS
AVTOZMAPrescription
TOCILIZUMAB-ANOH 162MG/0.9ML · INJECTABLE · SUBCUTANEOUS
AVTOZMAPrescription
TOCILIZUMAB-ANOH 200MG/10ML(20MG/ML) · INJECTABLE · INTRAVENOUS

Approval history

2026-01-14BIOSIMILAR · Supplement 5 — Letter ↗AP
2025-07-29BIOSIMILAR · Supplement 1 · standard — Label ↗AP
2025-01-24UNKNOWN · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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