Clobazam

ANDA 210746, held by Vistapharm LLC. Clobazam.

As of Nov 15, 2026, ANDA 210746 (Clobazam), held by Vistapharm LLC, was first approved by FDA on Jul 10, 2019, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 10, 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
Jul 10, 2019	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Jul 15, 2024	Supplement 10Labeling · Standard review	Approved	None posted
May 22, 2023	Supplement 7Labeling · Standard review	Approved	None posted
Feb 11, 2022	Supplement 1Labeling · Standard review	Approved	None posted
Jul 10, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 210746
Drugs@FDA: Overview at FDA
Company: VistaPharm

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