ADALIMUMAB-BWWD
Summary
FDA approved ADALIMUMAB-BWWD by SAMSUNG BIOEPIS CO LTD. BLA (Biologic) approval (Manufacturing (CMC)) on 2026-04-29. INJECTABLE, INJECTION.
Details
Source
Drug Approval
External ID
BLA761059-36
Action Date
2026-04-29
Status
Approved
Category
drug
Product Code
BLA (Biologic)
Product Description
ADALIMUMAB-BWWD, INJECTABLE, INJECTION. Application: BLA761059
Company
Context & Analysis
SAMSUNG BIOEPIS CO LTD has 5 FDA actions in our database, including 1 recall.
Frequently Asked Questions
How often does SAMSUNG BIOEPIS CO LTD have FDA actions?
SAMSUNG BIOEPIS CO LTD has 5 FDA actions in our database, including 1 recall and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "BLA761059-36" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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