Treats Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. NDA 17533, held by Cheplapharm. Clonazepam.
As of Nov 13, 2026, NDA 17533 (Klonopin), held by Cheplapharm, was first approved by FDA on Jun 4, 1975, with 50 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Seizure Disorders Klonopin is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, Klonopin may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect ). Panic Disorder Klonopin is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V.
| Apr 9, 1997 | Supplement 23Efficacy (new indication or use) · Standard review | Approved | None posted |
| Jun 4, 1975 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Klonopin0.5MG · tablet;oral | Clonazepam | RxReference drug |
| Klonopin1MG · tablet;oral | Clonazepam | RxReference drug |
| Klonopin2MG · tablet;oral | Clonazepam | RxReference drug |
| Klonopin0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Clonazepam | Discontinued |
| Klonopin0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Clonazepam | Discontinued |
| Jan 13, 2023 | Supplement 62Labeling · Standard review | Approved | |
| Feb 5, 2021 | Supplement 61Labeling · Standard review | Approved | |
| Oct 25, 2017 | Supplement 59Labeling · Standard review | Approved | |
| Dec 16, 2016 | Supplement 58Labeling · Standard review | Approved | |
| Nov 2, 2016 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Jun 13, 2016 | Supplement 56Manufacturing · Priority review | Approved | None posted |
| Mar 25, 2016 | Supplement 55Labeling · Standard review | Approved | |
| Feb 3, 2015 | Supplement 54Manufacturing · Priority review | Approved | None posted |
| Oct 31, 2013 | Supplement 53Labeling · Standard review | Approved | |
| Nov 29, 2011 | Supplement 52REMS | Approved | |
| Sep 1, 2010 | Supplement 46Labeling · Standard review | Approved | |
| Sep 1, 2010 | Supplement 48Labeling | Approved | |
| Apr 23, 2009 | Supplement 45Labeling | Approved | |
| Mar 15, 2002 | Supplement 39Manufacturing · Priority review | Approved | None posted |
| Mar 11, 2002 | Supplement 38Manufacturing · Priority review | Approved | None posted |
| Jan 29, 2002 | Supplement 37Labeling · Standard review | Approved | |
| Nov 7, 2001 | Supplement 36Manufacturing · Priority review | Approved | None posted |
| Sep 10, 2001 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Apr 11, 2001 | Supplement 31Labeling · Standard review | Approved | |
| Jan 22, 2001 | Supplement 34Manufacturing · Priority review | Approved | None posted |
| Mar 28, 2000 | Supplement 33Manufacturing · Priority review | Approved | None posted |
| Oct 18, 1999 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Dec 30, 1997 | Supplement 30Manufacturing · Priority review | Approved | None posted |
| Sep 19, 1997 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Apr 9, 1997 | Supplement 23Efficacy (new indication or use) · Standard review | Approved | None posted |
| Mar 7, 1997 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Nov 20, 1996 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Oct 17, 1996 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Aug 30, 1996 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Jun 18, 1996 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Jul 1, 1994 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Jun 3, 1993 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Jun 3, 1993 | Supplement 20Manufacturing · Priority review | Approved | None posted |
| May 28, 1993 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Apr 30, 1993 | Supplement 19Labeling | Approved | None posted |
| Apr 30, 1993 | Supplement 17Labeling | Approved | None posted |
| Jul 19, 1990 | Supplement 16Labeling | Approved | None posted |
| Jul 19, 1990 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| May 1, 1987 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Dec 13, 1985 | Supplement 13Labeling | Approved | None posted |
| Dec 11, 1984 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Dec 19, 1983 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Feb 24, 1981 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Jan 13, 1981 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Jun 13, 1980 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Sep 19, 1979 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Mar 23, 1979 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Aug 30, 1978 | Supplement 3Labeling | Approved | None posted |
| Sep 26, 1975 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Jun 30, 1975 | Supplement 2Labeling | Approved | None posted |
| Jun 4, 1975 | Original applicationNew molecular entity · Priority review | Approved | None posted |
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
