APPLICATION
ANDA090767
TYPE
ANDA
ORIGINAL APPROVAL
2010-07-28
LATEST ACTION
2025-02-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEVETIRACETAMPrescription
LEVETIRACETAM 750MG · TABLET · ORAL
LEVETIRACETAMPrescription
LEVETIRACETAM 250MG · TABLET · ORAL
LEVETIRACETAMPrescription
LEVETIRACETAM 1GM · TABLET · ORAL
LEVETIRACETAMPrescription
LEVETIRACETAM 500MG · TABLET · ORAL
Approval history
2025-02-25Labeling · Supplement 16 · standardAP
2025-02-25Labeling · Supplement 15 · standardAP
2022-07-15Manufacturing (CMC) · Supplement 13 · unknownAP
2022-06-17Labeling · Supplement 12 · standardAP
2022-06-17Labeling · Supplement 8 · standardAP
2022-06-17Labeling · Supplement 9 · standardAP
2022-06-17Labeling · Supplement 11 · standardAP
2022-06-17Labeling · Supplement 7 · standardAP
2015-10-02Labeling · Supplement 1AP
2015-10-02Labeling · Supplement 6 · standardAP
2015-10-02Labeling · Supplement 4 · standardAP
2015-10-02Labeling · Supplement 5 · standardAP
2015-10-02Labeling · Supplement 3 · standardAP
2010-07-28OriginalAP
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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