← FDA Drug Approvals (Drugs@FDA)

BRIVARACETAM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HAINAN POLY · Approved 2026-02-23

Drug application

FDA Application #

ANDA218249

Application type

Abbreviated New Drug Application (Generic)

Brand name

BRIVARACETAM

Generic name

BRIVARACETAM INJECTION

Active ingredients

BRIVARACETAM

Dosage form

SOLUTION

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

HAINAN POLY

Manufacturer

PAI Holdings, LLC dba PAI Pharma

First approval

2026-02-23

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown