← FDA DRUG APPROVALS

FDA ANDA · ANDA078731

LEVETIRACETAM

Sponsor: MYLAN

APPLICATION
ANDA078731
TYPE
ANDA
ORIGINAL APPROVAL
2009-02-10
LATEST ACTION
2009-02-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LEVETIRACETAMDiscontinued
LEVETIRACETAM 750MG · TABLET · ORAL
LEVETIRACETAMDiscontinued
LEVETIRACETAM 250MG · TABLET · ORAL
LEVETIRACETAMDiscontinued
LEVETIRACETAM 1GM · TABLET · ORAL
LEVETIRACETAMDiscontinued
LEVETIRACETAM 500MG · TABLET · ORAL

Approval history

2009-02-10OriginalAP
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.

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 →