← FDA DRUG APPROVALS

FDA ANDA · ANDA219952

BRIVARACETAM

Sponsor: SCIEGEN PHARMS

APPLICATION
ANDA219952
TYPE
ANDA
ORIGINAL APPROVAL
2026-07-01
LATEST ACTION
2026-07-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BRIVARACETAMPrescription
BRIVARACETAM 75MG · TABLET · ORAL
BRIVARACETAMPrescription
BRIVARACETAM 25MG · TABLET · ORAL
BRIVARACETAMPrescription
BRIVARACETAM 100MG · TABLET · ORAL
BRIVARACETAMPrescription
BRIVARACETAM 50MG · TABLET · ORAL
BRIVARACETAMPrescription
BRIVARACETAM 10MG · TABLET · ORAL

Approval history

2026-07-01UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →