Clobazam

ANDA 211032, held by Teva Pharms USA. Clobazam.

As of Nov 14, 2026, ANDA 211032 (Clobazam), held by Teva Pharms USA, was first approved by FDA on Jan 31, 2020, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 31, 2020
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
Jan 31, 2020	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


Mar 9, 2022	Supplement 1Labeling · Standard review	Approved	None posted
Jan 31, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 211032
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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