← FDA DRUG APPROVALS

FDA NDA · NDA216354

AUSTEDO XR

deutetrabenazine

Sponsor: TEVA

APPLICATION
NDA216354
TYPE
NDA
ORIGINAL APPROVAL
2023-02-17
LATEST ACTION
2025-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

AUSTEDO XR · ReferencePrescription
DEUTETRABENAZINE 12MG · TABLET, EXTENDED RELEASE · ORAL
AUSTEDO XR · ReferencePrescription
DEUTETRABENAZINE 48MG · TABLET, EXTENDED RELEASE · ORAL
AUSTEDO XR · ReferencePrescription
DEUTETRABENAZINE 36MG · TABLET, EXTENDED RELEASE · ORAL
AUSTEDO XR · ReferencePrescription
DEUTETRABENAZINE 24MG · TABLET, EXTENDED RELEASE · ORAL
AUSTEDO XR · ReferencePrescription
DEUTETRABENAZINE 6MG · TABLET, EXTENDED RELEASE · ORAL
AUSTEDO XR · ReferencePrescription
DEUTETRABENAZINE 18MG · TABLET, EXTENDED RELEASE · ORAL
AUSTEDO XR · ReferencePrescription
DEUTETRABENAZINE 42MG · TABLET, EXTENDED RELEASE · ORAL
AUSTEDO XR · ReferencePrescription
DEUTETRABENAZINE 30MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-02-28Labeling · Supplement 8 · standard — Label ↗AP
2024-07-01Manufacturing (CMC) · Supplement 7 — Letter ↗AP
2024-05-29Manufacturing (CMC) · Supplement 6 — Label ↗AP
2023-02-17Type 3 - New Dosage Form · 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.

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