Clobazam

Treats seizures associated with Lennox-Gastaut syndrome (LGS). ANDA 208819, held by Bionpharma. Clobazam.

As of Nov 14, 2026, ANDA 208819 (Clobazam), held by Bionpharma, 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 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 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	Letter

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 24, 2024	Supplement 7Labeling · Standard review	Approved	None posted
May 1, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Nov 12, 2021	Supplement 5Labeling · Standard review	Approved	None posted
Oct 22, 2018	Original application	Approved	Letter

Identifiers

Application: ANDA 208819
Drugs@FDA: Overview at FDA
Company: Bionpharma

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