Clonazepam

Treats Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. ANDA 75468, held by Rubicon Research. Clonazepam.

As of Nov 14, 2026, ANDA 75468 (Clonazepam), held by Rubicon Research, was first approved by FDA on Oct 6, 2000, with 9 approved supplements and 0 published complete response letters.

First approved: Oct 6, 2000
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Oct 6, 2000	Original application	Approved	Letter

Products

4 strengths and forms


Clonazepam0.5MG · tablet;oral	Clonazepam	Rx
Clonazepam1MG · tablet;oral	Clonazepam	Rx
Clonazepam2MG · tablet;oral	Clonazepam	Rx
Clonazepam0.25MG · tablet;oral	Clonazepam	Rx

All 10 submissions, including labeling and manufacturing supplements


Jun 12, 2026	Supplement 31Manufacturing	Approved	None posted
Jul 18, 2016	Supplement 19Labeling · Standard review	Approved	None posted
Aug 10, 2015	Supplement 18Labeling · Standard review	Approved	None posted
May 31, 2013	Supplement 17Labeling · Standard review	Approved	None posted
Jul 6, 2010	Supplement 16Labeling	Approved	None posted
Aug 4, 2003	Supplement 4Labeling	Approved	None posted
Jan 8, 2002	Supplement 1Manufacturing	Approved	None posted
Jan 8, 2002	Supplement 2Manufacturing	Approved	None posted
Jan 8, 2002	Supplement 3Labeling	Approved	None posted
Oct 6, 2000	Original application	Approved	Letter

Identifiers

Application: ANDA 75468
Drugs@FDA: Overview at FDA
Company: Rubicon Research

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