Clobazam

Treats seizures associated with Lennox-Gastaut syndrome (LGS). ANDA 209796, held by Hetero Labs Ltd Iii. Clobazam.

As of Nov 15, 2026, ANDA 209796 (Clobazam), held by Hetero Labs Ltd Iii, was first approved by FDA on Feb 24, 2020, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 24, 2020
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. Clobazam oral suspension 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
Feb 24, 2020	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Clobazam2.5MG/ML · suspension;oral	Clobazam	Rx

All 4 submissions, including labeling and manufacturing supplements


May 31, 2024	Supplement 3Labeling · Standard review	Approved	None posted
May 12, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Oct 20, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Feb 24, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 209796
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