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FDA ANDA · ANDA202143

LEVETIRACETAM

Sponsor: AM REGENT

APPLICATION
ANDA202143
TYPE
ANDA
ORIGINAL APPROVAL
2012-01-31
LATEST ACTION
2015-12-28
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

LEVETIRACETAMDiscontinued
LEVETIRACETAM 500MG/5ML (100MG/ML) · INJECTABLE · INTRAVENOUS

Approval history

2015-12-28Labeling · Supplement 3 · standardAP
2015-12-28Labeling · Supplement 4 · standardAP
2015-12-28Labeling · Supplement 2 · standardAP
2012-01-31Not Applicable · OriginalAP
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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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