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FDA NDA · NDA207958

LEVETIRACETAM

Sponsor: APRECIA PHARMS

APPLICATION
NDA207958
TYPE
NDA
ORIGINAL APPROVAL
2015-07-31
LATEST ACTION
2025-06-27
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Discontinued, Prescription

Products

SPRITAM · ReferenceDiscontinued
LEVETIRACETAM 1GM · TABLET, FOR SUSPENSION · ORAL
SPRITAM · ReferencePrescription
LEVETIRACETAM 500MG · TABLET, FOR SUSPENSION · ORAL
SPRITAM · ReferenceDiscontinued
LEVETIRACETAM 750MG · TABLET, FOR SUSPENSION · ORAL
SPRITAM · ReferencePrescription
LEVETIRACETAM 250MG · TABLET, FOR SUSPENSION · ORAL

Approval history

2025-06-27Efficacy · Supplement 27 · standard — Letter ↗AP
2024-06-14Labeling · Supplement 24 · standard — Letter ↗AP
2024-03-12Labeling · Supplement 25 · standard — Label ↗AP
2023-08-31Labeling · Supplement 23 · standard — Letter ↗AP
2021-01-19Efficacy · Supplement 19 · standard — Letter ↗AP
2018-09-12Labeling · Supplement 8 · standard — Letter ↗AP
2017-06-09Labeling · Supplement 4 · standard — Label ↗AP
2016-02-01Labeling · Supplement 2 · standard — Letter ↗AP
2015-12-14Manufacturing (CMC) · Supplement 1 · priorityAP
2015-07-31Type 3 - New Dosage Form · Original · standard — Label ↗AP
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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