FDA Drug Approval, N216354, AUSTEDO XR
FDA Drug Approval, N216354, AUSTEDO XR
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NDA: 216354
Company: TEVA
Drug Name: AUSTEDO XR
Active Ingredients: DEUTETRABENAZINE
Strength: 18MG
Dosage Form/Route: TABLET, EXTENDED RELEASE;ORAL
Action Date: 02/17/2023
Marketing Status: Prescription
Submission Classification:
Company: TEVA
Drug Name: AUSTEDO XR
Active Ingredients: DEUTETRABENAZINE
Strength: 18MG
Dosage Form/Route: TABLET, EXTENDED RELEASE;ORAL
Action Date: 02/17/2023
Marketing Status: Prescription
Submission Classification:
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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