Treats Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. ANDA 77147, held by Accord Hlthcare. Clonazepam.
As of Nov 14, 2026, ANDA 77147 (Clonazepam), held by Accord Hlthcare, was first approved by FDA on May 2, 2005, with 7 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Seizure Disorders: Clonazepam tablets are 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, clonazepam tablets may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect ). Panic Disorder: Clonazepam tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 2, 2005 | Original application | Approved | None posted |
| Clonazepam0.5MG · tablet;oral | Clonazepam | Rx |
| Clonazepam1MG · tablet;oral | Clonazepam | Rx |
| Clonazepam2MG · tablet;oral | Clonazepam | Rx |
| Jul 24, 2023 | Supplement 11Labeling · Standard review | Approved | None posted |
| Jul 24, 2023 | Supplement 13Labeling · Standard review | Approved | None posted |
| Jul 24, 2023 | Supplement 14Labeling · Standard review | Approved | None posted |
| Jul 18, 2016 | Supplement 8Labeling · Standard review | Approved | None posted |
| May 18, 2015 | Supplement 4Labeling | Approved | None posted |
| Jul 19, 2012 | Supplement 5Labeling · Standard review | Approved | None posted |
| Apr 25, 2011 | Supplement 1Labeling | Approved | None posted |
| May 2, 2005 | Original application | 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
