Clonazepam

Treats Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. ANDA 77171, held by Ph Health. Clonazepam.

As of Nov 14, 2026, ANDA 77171 (Clonazepam), held by Ph Health, was first approved by FDA on Aug 3, 2005, with 6 approved supplements and 0 published complete response letters.

First approved: Aug 3, 2005
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Seizure Disorders: Clonazepam orally disintegrating tablet 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, clonazepam orally disintegrating tablets may be useful. In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may reestablish efficacy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Aug 3, 2005	Original application	Approved	Letter

Products

5 strengths and forms


Clonazepam0.125MG · tablet, orally disintegrating;oral	Clonazepam	Rx
Clonazepam0.25MG · tablet, orally disintegrating;oral	Clonazepam	Rx
Clonazepam0.5MG · tablet, orally disintegrating;oral	Clonazepam	Rx
Clonazepam1MG · tablet, orally disintegrating;oral	Clonazepam	Rx
Clonazepam2MG · tablet, orally disintegrating;oral	Clonazepam	Rx

All 7 submissions, including labeling and manufacturing supplements


Jan 17, 2023	Supplement 19Labeling · Standard review	Approved	None posted
Feb 5, 2021	Supplement 17Labeling · Standard review	Approved	None posted
Jan 22, 2021	Supplement 13Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 11Labeling · Standard review	Approved	None posted
Jul 26, 2013	Supplement 8Labeling	Approved	None posted
Dec 7, 2009	Supplement 6Labeling	Approved	Letter
Aug 3, 2005	Original application	Approved	Letter

Identifiers

Application: ANDA 77171
Drugs@FDA: Overview at FDA
Company: PH Health

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