← FDA DRUG APPROVALS

FDA NDA · NDA021035

KEPPRA

levetiracetam

Sponsor: UCB INC

APPLICATION
NDA021035
TYPE
NDA
ORIGINAL APPROVAL
1999-11-30
LATEST ACTION
2024-03-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

KEPPRA · ReferencePrescription
LEVETIRACETAM 750MG · TABLET · ORAL
KEPPRA · ReferencePrescription
LEVETIRACETAM 250MG · TABLET · ORAL
KEPPRA · ReferencePrescription
LEVETIRACETAM 1GM · TABLET · ORAL
KEPPRA · ReferencePrescription
LEVETIRACETAM 500MG · TABLET · ORAL

Approval history

2024-03-12Labeling · Supplement 115 · standardLabelAP
2023-08-31Labeling · Supplement 113 · standardLetterAP
2023-08-17Labeling · Supplement 112 · standardLetterAP
2020-09-30Labeling · Supplement 104 · standardLetterAP
2019-10-23Efficacy · Supplement 102 · standardLabelAP
2017-10-24Labeling · Supplement 100 · standardLabelAP
2017-04-24Labeling · Supplement 99 · standardLabelAP
2016-10-26Labeling · Supplement 96 · standardLetterAP
2016-02-04Manufacturing (CMC) · Supplement 95 · standardAP
2015-03-10Labeling · Supplement 93 · standardLabelAP
2014-08-07Labeling · Supplement 94 · standardLabelAP
2014-03-07Labeling · Supplement 91 · standardLetterAP
2013-07-25Labeling · Supplement 89 · standardLetterAP
2012-11-13Manufacturing (CMC) · Supplement 92 · standardAP
2011-12-16Labeling · Supplement 83 · standardLabelAP
2011-12-16Efficacy · Supplement 73 · priorityPediatric Written RequestAP
2011-12-16Labeling · Supplement 74 · standardLetterAP
2011-12-16Labeling · Supplement 52 · standardLetterAP
2011-12-16Labeling · Supplement 85 · standardLetterAP
2011-08-10REMS · Supplement 90LetterAP
2009-04-23Labeling · Supplement 78 · 901 requiredLetterAP
2009-04-23Labeling · Supplement 80 · standardLetterAP
2009-04-23Labeling · Supplement 79 · standardAP
2007-09-12Labeling · Supplement 62 · standardLetterAP
2007-03-19Efficacy · Supplement 57 · standardLabelAP
2006-08-16Manufacturing (CMC) · Supplement 55AP
2006-08-15Labeling · Supplement 54 · standardLetterAP
2006-08-15Efficacy · Supplement 50 · unknownLetterAP
2006-01-24Labeling · Supplement 38 · standardLetterAP
2006-01-06Manufacturing (CMC) · Supplement 48 · standardLetterAP
2005-06-21Efficacy · Supplement 40 · priorityLabelAP
2004-10-26Labeling · Supplement 33 · standardLetterAP
2004-10-26Labeling · Supplement 32 · standardLetterAP
2003-09-03Labeling · Supplement 30 · standardLetterAP
2002-10-17Manufacturing (CMC) · Supplement 22 · standardAP
2002-05-22Labeling · Supplement 19 · standardLetterAP
2002-05-22Labeling · Supplement 13 · standardLetterAP
2002-05-07Manufacturing (CMC) · Supplement 18 · standardAP
2002-04-17Manufacturing (CMC) · Supplement 21 · standardAP
2002-04-01Manufacturing (CMC) · Supplement 20 · standardAP
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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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