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General MedicationsORALStandard

AUSTEDO XR

DEUTETRABENAZINE

Standard Dose
12MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview AUSTEDO XR is listed in Drugs@FDA under application 216354 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DEUTETRABENAZINE Form and strength TABLET, EXTENDED RELEASE;ORAL - 12MG Sponsor TEVA Submission history Latest submission status date: 2025-02-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview AUSTEDO XR is listed in Drugs@FDA under application 216354 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DEUTETRABENAZINE Form and strength TABLET, EXTENDED RELEASE;ORAL - 12MG Sponsor TEVA Submission history Latest submission status date: 2025-02-28 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
AUSTEDO XR (DEUTETRABENAZINE) | Drug Monograph | MedicHelpline