← FDA DRUG APPROVALS

FDA BLA · BLA761275

TYENNE

tocilizumab-aazg

Sponsor: FRESENIUS KABI USA

APPLICATION
BLA761275
TYPE
BLA
ORIGINAL APPROVAL
2024-03-05
LATEST ACTION
2026-05-21
ROUTE
INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

TYENNEPrescription
TOCILIZUMAB-AAZG 400MG/20ML · INJECTABLE · INTRAVENOUS
TYENNEPrescription
TOCILIZUMAB-AAZG 80MG/4ML · INJECTABLE · INTRAVENOUS
TYENNEPrescription
TOCILIZUMAB-AAZG 200MG/10ML · INJECTABLE · INTRAVENOUS

Approval history

2026-05-21Labeling · Supplement 22 · standard — Label ↗AP
2026-01-21Labeling · Supplement 19 · standard — Letter ↗AP
2025-05-12Labeling · Supplement 4 · standard — Letter ↗AP
2025-03-13Labeling · Supplement 15 · standard — Label ↗AP
2025-02-28BIOSIMILAR · Supplement 8 · standard — Label ↗AP
2024-12-13Labeling · Supplement 13 · standard — Label ↗AP
2024-12-03Labeling · Supplement 11 · standard — Letter ↗AP
2024-09-05Manufacturing (CMC) · Supplement 1 — Label ↗AP
2024-03-05UNKNOWN · Original · standard — Letter ↗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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