Treats partial-onset seizures. NDA 21035, held by Ucb Inc. Levetiracetam.
As of Nov 14, 2026, NDA 21035 (Keppra), held by Ucb Inc, was first approved by FDA on Nov 30, 1999, with 54 approved supplements and 0 published complete response letters.
KEPPRA is indicated for the treatment of partial-onset seizures in patients 1 month of age and older KEPPRA is indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy 1.1 Partial-Onset Seizures
| Oct 23, 2019 | Supplement 102Efficacy (new indication or use) · Standard review | Approved | |
| Dec 16, 2011 | Supplement 73Efficacy (new indication or use) · Priority review | Approved | |
| Mar 19, 2007 | Supplement 57Efficacy (new indication or use) · Standard review | Approved | |
| Aug 15, 2006 | Supplement 50Efficacy (new indication or use) | Approved | |
| Jun 21, 2005 | Supplement 40Efficacy (new indication or use) · Priority review | Approved | |
| Nov 30, 1999 | Original applicationNew molecular entity · Standard review | Approved |
| Keppra250MG · tablet;oral | Levetiracetam | RxReference drug |
| Keppra500MG · tablet;oral | Levetiracetam | RxReference drug |
| Keppra750MG · tablet;oral | Levetiracetam | RxReference drug |
| Keppra1GM · tablet;oral | Levetiracetam | RxReference drug |
| Mar 12, 2024 | Supplement 115Labeling · Standard review | Approved | |
| Aug 31, 2023 | Supplement 113Labeling · Standard review | Approved | |
| Aug 17, 2023 | Supplement 112Labeling · Standard review | Approved | |
| Sep 30, 2020 | Supplement 104Labeling · Standard review | Approved | |
| Oct 23, 2019 | Supplement 102Efficacy (new indication or use) · Standard review | Approved | |
| Oct 24, 2017 | Supplement 100Labeling · Standard review | Approved | |
| Apr 24, 2017 | Supplement 99Labeling · Standard review | Approved | |
| Oct 26, 2016 | Supplement 96Labeling · Standard review | Approved | |
| Feb 4, 2016 | Supplement 95Manufacturing · Standard review | Approved | None posted |
| Mar 10, 2015 | Supplement 93Labeling · Standard review | Approved | |
| Aug 7, 2014 | Supplement 94Labeling · Standard review | Approved | |
| Mar 7, 2014 | Supplement 91Labeling · Standard review | Approved | |
| Jul 25, 2013 | Supplement 89Labeling · Standard review | Approved | |
| Nov 13, 2012 | Supplement 92Manufacturing · Standard review | Approved | None posted |
| Dec 16, 2011 | Supplement 52Labeling · Standard review | Approved | |
| Dec 16, 2011 | Supplement 73Efficacy (new indication or use) · Priority review | Approved | |
| Dec 16, 2011 | Supplement 74Labeling · Standard review | Approved | |
| Dec 16, 2011 | Supplement 83Labeling · Standard review | Approved | |
| Dec 16, 2011 | Supplement 85Labeling · Standard review | Approved | |
| Aug 10, 2011 | Supplement 90REMS | Approved | |
| Apr 23, 2009 | Supplement 78Labeling | Approved | |
| Apr 23, 2009 | Supplement 79Labeling · Standard review | Approved | None posted |
| Apr 23, 2009 | Supplement 80Labeling · Standard review | Approved | |
| Sep 12, 2007 | Supplement 62Labeling · Standard review | Approved | |
| Mar 19, 2007 | Supplement 57Efficacy (new indication or use) · Standard review | Approved | |
| Aug 16, 2006 | Supplement 55Manufacturing | Approved | None posted |
| Aug 15, 2006 | Supplement 54Labeling · Standard review | Approved | |
| Aug 15, 2006 | Supplement 50Efficacy (new indication or use) | Approved | |
| Jan 24, 2006 | Supplement 38Labeling · Standard review | Approved | |
| Jan 6, 2006 | Supplement 48Manufacturing · Standard review | Approved | |
| Jun 21, 2005 | Supplement 40Efficacy (new indication or use) · Priority review | Approved | |
| Oct 26, 2004 | Supplement 32Labeling · Standard review | Approved | |
| Oct 26, 2004 | Supplement 33Labeling · Standard review | Approved | |
| Sep 3, 2003 | Supplement 30Labeling · Standard review | Approved | |
| Oct 17, 2002 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| May 22, 2002 | Supplement 13Labeling · Standard review | Approved | |
| May 22, 2002 | Supplement 19Labeling · Standard review | Approved | |
| May 7, 2002 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Apr 17, 2002 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Apr 1, 2002 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Jan 4, 2002 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jan 4, 2002 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Nov 27, 2001 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Nov 27, 2001 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Oct 24, 2001 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jul 5, 2001 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Apr 26, 2001 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Dec 4, 2000 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Dec 4, 2000 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Oct 4, 2000 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Aug 9, 2000 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jul 27, 2000 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| May 15, 2000 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Apr 10, 2000 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 30, 1999 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
