← FDA Drug Approvals (Drugs@FDA)

BRIVARACETAM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2026-02-23

Drug application

FDA Application #

ANDA219772

Application type

Abbreviated New Drug Application (Generic)

Brand name

BRIVARACETAM

Generic name

BRIVARACETAM

Active ingredients

BRIVARACETAM

Dosage form

SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

ALKEM LABS LTD

Manufacturer

Ascend Laboratories, LLC

First approval

2026-02-23

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown