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FDA ANDA · ANDA090906

LEVETIRACETAM

Sponsor: LOTUS PHARM CO LTD

APPLICATION
ANDA090906
TYPE
ANDA
ORIGINAL APPROVAL
2010-11-05
LATEST ACTION
2016-10-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2016-10-31Manufacturing (CMC) · Supplement 2 — Letter ↗AP
2015-12-26Labeling · Supplement 7 · standardAP
2015-11-24Labeling · Supplement 6 · standardAP
2015-01-16Labeling · Supplement 5 · standardAP
2010-11-05OriginalAP
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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