← FDA DRUG APPROVALS

FDA NDA · NDA208082

AUSTEDO

deutetrabenazine

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA208082
TYPE
NDA
ORIGINAL APPROVAL
2017-04-03
LATEST ACTION
2025-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

AUSTEDO · ReferencePrescription
DEUTETRABENAZINE 9MG · TABLET · ORAL
AUSTEDO · ReferencePrescription
DEUTETRABENAZINE 12MG · TABLET · ORAL
AUSTEDO · ReferencePrescription
DEUTETRABENAZINE 6MG · TABLET · ORAL

Approval history

2025-02-28Labeling · Supplement 18 · standard — Label ↗AP
2024-11-26Labeling · Supplement 17 · standard — Letter ↗AP
2024-11-26Labeling · Supplement 16 · standard — Letter ↗AP
2023-09-28Labeling · Supplement 14 · standard — Label ↗AP
2022-05-04Labeling · Supplement 11 · standard — Label ↗AP
2021-06-24Efficacy · Supplement 9 · priority — Letter ↗AP
2021-02-09Labeling · Supplement 8 · standard — Letter ↗AP
2020-12-02Labeling · Supplement 7 · standard — Label ↗AP
2019-07-15Labeling · Supplement 4 · standard — Letter ↗AP
2018-06-06Labeling · Supplement 2 · standard — Label ↗AP
2017-04-03Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →