Treats Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. ANDA 75150, held by Aurobindo Pharma USA. Clonazepam.
As of Nov 14, 2026, ANDA 75150 (Clonazepam), held by Aurobindo Pharma USA, was first approved by FDA on Oct 5, 1998, with 5 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 |
|---|---|---|---|
| Oct 5, 1998 | Original application | Approved |
| Clonazepam0.5MG · tablet;oral | Clonazepam | Rx |
| Clonazepam1MG · tablet;oral | Clonazepam | Rx |
| Clonazepam2MG · tablet;oral | Clonazepam | Rx |
| Oct 25, 2012 | Supplement 15Labeling · Standard review | Approved | None posted |
| Apr 8, 2011 | Supplement 13Labeling | Approved | None posted |
| Oct 15, 2009 | Supplement 11Labeling | Approved | None posted |
| Nov 24, 2003 | Supplement 3Labeling | Approved | None posted |
| Feb 28, 2001 | Supplement 1Labeling | Approved | None posted |
| Oct 5, 1998 | 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
