APPLICATION
ANDA090261
TYPE
ANDA
ORIGINAL APPROVAL
2009-12-08
LATEST ACTION
2025-02-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEVETIRACETAMPrescription
LEVETIRACETAM 1GM · TABLET · ORAL
Approval history
2025-02-10Labeling · Supplement 23 · standardAP
2025-02-10Labeling · Supplement 21 · standardAP
2025-02-10Labeling · Supplement 18 · standardAP
2025-02-10Labeling · Supplement 24 · standardAP
2025-02-10Labeling · Supplement 16 · standardAP
2025-02-10Labeling · Supplement 30 · standardAP
2025-02-10Labeling · Supplement 14 · standardAP
2025-02-10Labeling · Supplement 20 · standardAP
2025-02-10Labeling · Supplement 29 · standardAP
2014-09-24Labeling · Supplement 9 · standardAP
2014-09-24Labeling · Supplement 11 · standardAP
2014-09-24Labeling · Supplement 8 · standardAP
2014-09-24Labeling · Supplement 6AP
2014-09-24Labeling · Supplement 12 · standardAP
2009-12-08OriginalAP
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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