← FDA DRUG APPROVALS

FDA ANDA · ANDA219583

BRIVARACETAM

Sponsor: SHANDONG NEW TIME PHARMACEUTICAL CO LTD

APPLICATION
ANDA219583
TYPE
ANDA
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

BRIVARACETAMNone (Tentative Approval)
BRIVARACETAM 100MG · TABLET
BRIVARACETAMNone (Tentative Approval)
BRIVARACETAM 50MG · TABLET
BRIVARACETAMNone (Tentative Approval)
BRIVARACETAM 10MG · TABLET
BRIVARACETAMNone (Tentative Approval)
BRIVARACETAM 75MG · TABLET
BRIVARACETAMNone (Tentative Approval)
BRIVARACETAM 25MG · TABLET

Approval history

2026-02-26UNKNOWN · Original · standardTA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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.

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