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FDA NDA 216354, AUSTEDO XR, TEVA, 02/17/2023

FDA NDA 216354, AUSTEDO XR, TEVA, 02/17/2023

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Contents: Summary Basis of Approval of DEUTETRABENAZINE (AUSTEDO XR) TABLET, EXTENDED RELEASE ORAL 18MG; 30MG;36MG;42MG;48MG for the Applicant TEVA NEUROSCIENCE INC

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: ORIG-1
Action Date: None

252 pages
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