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FDA BLA · BLA761066

ETICOVO

Sponsor: SAMSUNG BIOEPIS CO LTD

APPLICATION
BLA761066
TYPE
BLA
ORIGINAL APPROVAL
2019-04-25
LATEST ACTION
2025-12-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ETICOVOPrescription
ETANERCEPT-YKRO 50MG/1ML · INJECTABLE · INJECTION
ETICOVOPrescription
ETANERCEPT-YKRO 25MG/0.5ML · INJECTABLE · INJECTION

Approval history

2025-12-05Labeling · Supplement 6 · standard — Letter ↗AP
2024-05-03Efficacy · Supplement 3 · standard — Letter ↗AP
2024-05-03Efficacy · Supplement 1 · standard — Label ↗AP
2019-04-25Type 2 - New Active Ingredient · 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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