Clobazam

Treats seizures associated with Lennox-Gastaut syndrome (LGS). ANDA 210545, held by Lupin. Clobazam.

As of Nov 15, 2026, ANDA 210545 (Clobazam), held by Lupin, was first approved by FDA on Dec 14, 2018, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 14, 2018
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Clobazam tablets are a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older Clobazam tablets are indicated for the 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
Dec 14, 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


May 15, 2024	Supplement 5Labeling · Standard review	Approved	None posted
May 1, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Dec 3, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Dec 14, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 210545
Drugs@FDA: Overview at FDA
Company: Lupin

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