Clobazam

ANDA 210569, held by Upsher Smith Labs. Clobazam.

As of Nov 15, 2026, ANDA 210569 (Clobazam), held by Upsher Smith Labs, was first approved by FDA on Oct 22, 2018, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 22, 2018
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Oct 22, 2018	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Dec 3, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Oct 22, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 210569
Drugs@FDA: Overview at FDA
Company: Upsher-Smith 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