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FDA ANDA · ANDA076919

LEVETIRACETAM

Sponsor: MYLAN

APPLICATION
ANDA076919
TYPE
ANDA
ORIGINAL APPROVAL
2008-11-04
LATEST ACTION
2025-02-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

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

Approval history

2025-02-10Labeling · Supplement 19 · standardAP
2025-02-10Labeling · Supplement 25 · standardAP
2025-02-10Labeling · Supplement 17 · standardAP
2025-02-10Labeling · Supplement 31 · standardAP
2025-02-10Labeling · Supplement 15 · standardAP
2025-02-10Labeling · Supplement 21 · standardAP
2025-02-10Labeling · Supplement 24 · standardAP
2025-02-10Labeling · Supplement 30 · standardAP
2025-02-10Labeling · Supplement 22 · standardAP
2014-09-24Labeling · Supplement 13 · standardAP
2014-09-24Labeling · Supplement 11 · standardAP
2014-09-24Labeling · Supplement 8AP
2014-09-24Labeling · Supplement 14 · standardAP
2014-09-24Labeling · Supplement 10 · standardAP
2009-11-02Labeling · Supplement 4AP
2008-11-04Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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