Clobazam

Treats seizures associated with Lennox-Gastaut syndrome (LGS). ANDA 212714, held by Alkem Labs Ltd. Clobazam.

As of Nov 15, 2026, ANDA 212714 (Clobazam), held by Alkem Labs Ltd, was first approved by FDA on Sep 6, 2019, with 4 approved supplements and 0 published complete response letters.

First approved: Sep 6, 2019
Review: Standard
Supplements approved: 4
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 tablet 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 5 submissions below

Date	Submission	Status	Documents
Sep 6, 2019	Original application	Approved	None posted

Products

3 strengths and forms


Clobazam10MG · tablet;oral	Clobazam	Rx
Clobazam20MG · tablet;oral	Clobazam	Rx
Clobazam5MG · tablet;oral	Clobazam	Rx

All 5 submissions, including labeling and manufacturing supplements


Sep 24, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Sep 24, 2024	Supplement 7Labeling · Standard review	Approved	None posted
May 1, 2023	Supplement 2Labeling · Standard review	Approved	None posted
May 1, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Sep 6, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 212714
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