Treats Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. ANDA 74925, held by Chartwell Rx. Clonazepam.
As of Nov 14, 2026, ANDA 74925 (Clonazepam), held by Chartwell Rx, was first approved by FDA on Sep 30, 1997, with 2 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 |
|---|---|---|---|
| Sep 30, 1997 | Original application | Approved |
| Clonazepam0.5MG · tablet;oral | Clonazepam | Rx |
| Clonazepam1MG · tablet;oral | Clonazepam | Rx |
| Clonazepam2MG · tablet;oral | Clonazepam | Rx |
| Nov 23, 1998 | Supplement 2Manufacturing | Approved | None posted |
| Oct 7, 1998 | Supplement 1Manufacturing | Approved | None posted |
| Sep 30, 1997 | Original application | 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
