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FDA BLA · BLA761183

TZIELD

Sponsor: PROVENTION BIO INC

APPLICATION
BLA761183
TYPE
BLA
ORIGINAL APPROVAL
2022-11-17
LATEST ACTION
2026-06-12
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

TZIELDPrescription
TEPLIZUMAB-MZWV 2MG/2ML(1MG/ML) · INJECTABLE · INJECTION

Approval history

2026-06-12Efficacy · Supplement 10 · priority — Letter ↗AP
2026-06-12Manufacturing (CMC) · Supplement 14 — Letter ↗AP
2026-04-20Efficacy · Supplement 13 · priority — Letter ↗AP
2022-11-17Type 1 - New Molecular Entity · Original · priority — 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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