APPLICATION
ANDA205102
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-16
LATEST ACTION
2025-08-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, None (Tentative Approval)
Products
LEVETIRACETAMDiscontinued
LEVETIRACETAM 500MG · TABLET · ORAL
LEVETIRACETAMNone (Tentative Approval)
LEVETIRACETAM 750MG · TABLET · ORAL
LEVETIRACETAMDiscontinued
LEVETIRACETAM 1GM · TABLET · ORAL
LEVETIRACETAMNone (Tentative Approval)
LEVETIRACETAM 250MG · TABLET · ORAL
Approval history
2025-08-12Labeling · Supplement 2 · standardAP
2025-08-12Labeling · Supplement 3 · standardAP
2025-08-12Labeling · Supplement 1 · standardAP
2015-12-16UNKNOWN · Original · standardTA
2015-12-16UNKNOWN · Original · standardAP
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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