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FDA ANDA · ANDA091485

LEVETIRACETAM

Sponsor: XGEN PHARMS

APPLICATION
ANDA091485
TYPE
ANDA
ORIGINAL APPROVAL
2011-08-05
LATEST ACTION
2020-07-24
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

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

Approval history

2020-07-24Labeling · Supplement 3 · standardAP
2020-07-24Labeling · Supplement 4 · standardAP
2011-08-05OriginalAP
VIEW ON DRUGS@FDA ↗

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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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