Clobazam

Treats seizures associated with Lennox-Gastaut syndrome (LGS). ANDA 213039, held by Alkem Labs Ltd. Clobazam.

As of Nov 14, 2026, ANDA 213039 (Clobazam), held by Alkem Labs Ltd, was first approved by FDA on May 6, 2021, with 2 approved supplements and 0 published complete response letters.

First approved: May 6, 2021
Review: Standard
Supplements approved: 2
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 3 submissions below

Date	Submission	Status	Documents
May 6, 2021	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Feb 19, 2025	Supplement 5Labeling · Standard review	Approved	None posted
Apr 26, 2023	Supplement 4Labeling · Standard review	Approved	None posted
May 6, 2021	Original application	Approved	None posted

Identifiers

Application: ANDA 213039
Drugs@FDA: Overview at FDA
Company: Alkem Laboratories

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