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FDA ANDA · ANDA091093

LEVETIRACETAM

Sponsor: ACTAVIS LABS FL INC

APPLICATION
ANDA091093
TYPE
ANDA
ORIGINAL APPROVAL
2011-09-12
LATEST ACTION
2014-09-26
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

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

Approval history

2014-09-26Labeling · Supplement 3 · standardAP
2011-09-12Original — Review ↗AP
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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