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FDA ANDA · ANDA077319

LEVETIRACETAM

Sponsor: OXFORD PHARMS

APPLICATION
ANDA077319
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-20
LATEST ACTION
2014-09-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LEVETIRACETAMPrescription
LEVETIRACETAM 500MG · TABLET · ORAL
LEVETIRACETAMPrescription
LEVETIRACETAM 750MG · TABLET · ORAL
LEVETIRACETAMPrescription
LEVETIRACETAM 250MG · TABLET · ORAL

Approval history

2014-09-12Labeling · Supplement 5 · standardAP
2012-10-25Labeling · Supplement 4 · standardAP
2010-01-12Labeling · Supplement 2AP
2009-03-20Original — Other Important Information from FDA ↗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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