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BRIVARACETAM

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

Drug application

FDA Application #

ANDA220385

Application type

Abbreviated New Drug Application (Generic)

Brand name

BRIVARACETAM

Generic name

BRIVARACETAM ORAL

Active ingredients

BRIVARACETAM

Dosage form

SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

REGCON HOLDINGS

Manufacturer

Florida Pharmaceutical Products, LLC

First approval

2026-02-23

Source

Authoritative

Drugs@FDA application overview

Machine

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