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FDA BLA · BLA761054

RENFLEXIS

Sponsor: SAMSUNG BIOEPIS CO LTD

APPLICATION
BLA761054
TYPE
BLA
ORIGINAL APPROVAL
2017-04-21
LATEST ACTION
2025-10-28
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

RENFLEXISPrescription
INFLIXIMAB-ABDA 100MG · INJECTABLE · INJECTION

Approval history

2025-10-28Labeling · Supplement 41 · standard — Label ↗AP
2023-12-26Labeling · Supplement 21 · standard — Label ↗AP
2022-01-27Manufacturing (CMC) · Supplement 29 — Letter ↗AP
2019-06-26Efficacy · Supplement 9 · standard — Letter ↗AP
2019-03-21Labeling · Supplement 4 · standard — Label ↗AP
2017-04-21Type 5 - New Formulation or New Manufacturer · 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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