← FDA DRUG APPROVALS

FDA ANDA · ANDA091285

LEVETIRACETAM

Sponsor: SUN PHARM INDUSTRIES

APPLICATION
ANDA091285
TYPE
ANDA
ORIGINAL APPROVAL
2011-09-12
LATEST ACTION
2015-01-17
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

LEVETIRACETAMDiscontinued
LEVETIRACETAM 500MG · TABLET, EXTENDED RELEASE · ORAL
LEVETIRACETAMDiscontinued
LEVETIRACETAM 750MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2015-01-17Labeling · Supplement 2 · standardAP
2015-01-17Labeling · Supplement 1 · standardAP
2011-09-12OriginalLetterAP
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 →