Clobazam

Treats seizures associated with Lennox-Gastaut syndrome (LGS). ANDA 209795, held by Hetero Labs Ltd Iii. Clobazam.

As of Nov 15, 2026, ANDA 209795 (Clobazam), held by Hetero Labs Ltd Iii, was first approved by FDA on Oct 22, 2018, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 22, 2018
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Clobazam tablet is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. Clobazam is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Oct 22, 2018	Original application	Approved	None posted

Products

2 strengths and forms


Clobazam10MG · tablet;oral	Clobazam	Rx
Clobazam20MG · tablet;oral	Clobazam	Rx

All 4 submissions, including labeling and manufacturing supplements


Jun 10, 2024	Supplement 5Labeling · Standard review	Approved	None posted
May 1, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Oct 8, 2021	Supplement 2Labeling · Standard review	Approved	None posted
Oct 22, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 209795
Drugs@FDA: Overview at FDA
Company: Hetero Labs Ltd Iii

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