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FDA BLA · BLA761091

HERZUMA

trastuzumab

Sponsor: CELLTRION INC

APPLICATION
BLA761091
TYPE
BLA
ORIGINAL APPROVAL
2018-12-14
LATEST ACTION
2025-05-22
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

HERZUMAPrescription
TRASTUZUMAB-PKRB 420MG · INJECTABLE · INJECTION

Approval history

2025-05-22Labeling · Supplement 35 · standard — Letter ↗AP
2024-11-13BIOSIMILAR · Supplement 33 · standard — Label ↗AP
2019-05-16Efficacy · Supplement 2 · standard — Letter ↗AP
2019-05-16Manufacturing (CMC) · Supplement 1 · standard — Letter ↗AP
2018-12-14UNKNOWN · 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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