← FDA DRUG APPROVALS

FDA NDA · NDA021872

KEPPRA

levetiracetam

Sponsor: UCB INC

APPLICATION
NDA021872
TYPE
NDA
ORIGINAL APPROVAL
2006-07-31
LATEST ACTION
2024-03-12
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

KEPPRA · ReferencePrescription
LEVETIRACETAM 500MG/5ML (100MG/ML) · INJECTABLE · INTRAVENOUS

Approval history

2024-03-12Labeling · Supplement 35 · standard — Label ↗AP
2023-08-17Labeling · Supplement 34 · standard — Letter ↗AP
2020-09-30Labeling · Supplement 29 · standard — Letter ↗AP
2019-10-23Efficacy · Supplement 28 · standard — Label ↗AP
2017-10-24Labeling · Supplement 24 · standard — Label ↗AP
2017-04-24Labeling · Supplement 23 · standard — Label ↗AP
2016-10-26Labeling · Supplement 22 · standard — Letter ↗AP
2016-04-06Labeling · Supplement 21 · standard — Label ↗AP
2015-08-14Manufacturing (CMC) · Supplement 19 · standardAP
2015-03-10Labeling · Supplement 17 · standard — Label ↗AP
2014-10-30Efficacy · Supplement 16 · standard — Letter ↗AP
2014-08-07Labeling · Supplement 18 · standard — Letter ↗AP
2014-03-07Labeling · Supplement 15 · standard — Letter ↗AP
2013-07-25Labeling · Supplement 12 · unknown — Letter ↗AP
2013-07-25Labeling · Supplement 13 · standard — Letter ↗AP
2008-05-16Efficacy · Supplement 5 · standard — Letter ↗AP
2007-09-12Labeling · Supplement 2 · standard — Letter ↗AP
2007-09-12Efficacy · Supplement 3 · unknown — Label ↗AP
2006-07-31Type 3 - New Dosage Form · Original · standard — Label ↗AP
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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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