Clobazam

ANDA 212398, held by Accord Hlthcare. Clobazam.

As of Nov 15, 2026, ANDA 212398 (Clobazam), held by Accord Hlthcare, was first approved by FDA on May 23, 2019, with 3 approved supplements and 0 published complete response letters.

First approved: May 23, 2019
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
May 23, 2019	Original application	Approved	None posted

Products

2 strengths and forms


Clobazam10MG · tablet;oral	Clobazam	Discontinued
Clobazam20MG · tablet;oral	Clobazam	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Sep 26, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Aug 8, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Nov 8, 2021	Supplement 1Labeling · Standard review	Approved	None posted
May 23, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 212398
Drugs@FDA: Overview at FDA
Company: Accord Healthcare

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