← FDA Drug Approvals (Drugs@FDA)

EPYSQLI

BLA · Biologics License Application · Sponsor: SAMSUNG BIOEPIS CO LTD · Approved 2024-07-19

Drug application

FDA Application #

BLA761340

Application type

Biologics License Application

Brand name

EPYSQLI

Generic name

ECULIZUMAB-AAGH

Active ingredients

ECULIZUMAB-AAGH

Dosage form

INJECTION

Route

SOLUTION

Marketing status

Prescription

Sponsor

SAMSUNG BIOEPIS CO LTD

Manufacturer

Teva Pharmaceuticals USA, Inc.

First approval

2024-07-19

Source

Authoritative

Drugs@FDA application overview

Machine

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