Austedo

NDA 208082, held by Teva Branded Pharm. Deutetrabenazine.

As of Nov 14, 2026, NDA 208082 (Austedo), held by Teva Branded Pharm, was first approved by FDA on Apr 3, 2017, with 10 approved supplements and 1 published complete response letter.

First approved: Apr 3, 2017
Review: Standard
Supplements approved: 10
Complete response letters: 1

What It's For

From the FDA-approved label (Indications and Usage)

AUSTEDO XR and AUSTEDO are indicated in adults for the treatment of: chorea associated with Huntington’s disease tardive dyskinesia AUSTEDO XR and AUSTEDO are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated in adults for the treatment of: Chorea associated with Huntington’s disease Tardive dyskinesia

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below


Jun 24, 2021	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Label Letter
Apr 3, 2017	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
May 27, 2016	Austedo (deutetrabenazine)Clinical Pharmacology, Nonclinical, Product Quality	Approved

Products

3 strengths and forms


Austedo6MG · tablet;oral	Deutetrabenazine	RxReference drug
Austedo9MG · tablet;oral	Deutetrabenazine	RxReference drug
Austedo12MG · tablet;oral	Deutetrabenazine	RxReference drug

All 11 submissions, including labeling and manufacturing supplements


Feb 28, 2025	Supplement 18Labeling · Standard review	Approved	Letter Label Medication Guide
Nov 26, 2024	Supplement 16Labeling · Standard review	Approved	Label Letter
Nov 26, 2024	Supplement 17Labeling · Standard review	Approved	Label Letter
Sep 28, 2023	Supplement 14Labeling · Standard review	Approved	Label Letter
May 4, 2022	Supplement 11Labeling · Standard review	Approved	Label Letter
Jun 24, 2021	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Label Letter
Feb 9, 2021	Supplement 8Labeling · Standard review	Approved	Label Letter
Dec 2, 2020	Supplement 7Labeling · Standard review	Approved	Letter Label
Jul 15, 2019	Supplement 4Labeling · Standard review	Approved	Letter Label
Jun 6, 2018	Supplement 2Labeling · Standard review	Approved	Letter Label
Apr 3, 2017	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 208082
Drugs@FDA: Overview at FDA
Company: Teva Branded Pharmaceutical Products

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