← FDA Drug Approvals (Drugs@FDA)

HADLIMA

BLA · Biologics License Application · Sponsor: SAMSUNG BIOEPIS CO LTD · Approved 2019-07-23

Drug application

FDA Application #

BLA761059

Application type

Biologics License Application

Brand name

HADLIMA

Generic name

ADALIMUMAB-BWWD

Active ingredients

ADALIMUMAB-BWWD

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

Prescription

Sponsor

SAMSUNG BIOEPIS CO LTD

Manufacturer

Cordavis Limited

First approval

2019-07-23

Source

Authoritative

Drugs@FDA application overview

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