Product Details for NDA 216354
AUSTEDO XR (DEUTETRABENAZINE)
6MG
Marketing Status: Prescription
12MG
Marketing Status: Prescription
24MG
Marketing Status: Prescription
6MG
Marketing Status: Prescription
Active Ingredient: DEUTETRABENAZINE
Proprietary Name: AUSTEDO XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 6MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N216354
Product Number: 001
Approval Date: Feb 17, 2023
Applicant Holder Full Name: TEVA NEUROSCIENCE INC
Marketing Status: Prescription
Patent and Exclusivity Information
AUSTEDO XR (DEUTETRABENAZINE)
Proprietary Name: AUSTEDO XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 6MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N216354
Product Number: 001
Approval Date: Feb 17, 2023
Applicant Holder Full Name: TEVA NEUROSCIENCE INC
Marketing Status: Prescription
Patent and Exclusivity Information
12MG
Marketing Status: Prescription
Active Ingredient: DEUTETRABENAZINE
Proprietary Name: AUSTEDO XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 12MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N216354
Product Number: 002
Approval Date: Feb 17, 2023
Applicant Holder Full Name: TEVA NEUROSCIENCE INC
Marketing Status: Prescription
Patent and Exclusivity Information
AUSTEDO XR (DEUTETRABENAZINE)
Proprietary Name: AUSTEDO XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 12MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N216354
Product Number: 002
Approval Date: Feb 17, 2023
Applicant Holder Full Name: TEVA NEUROSCIENCE INC
Marketing Status: Prescription
Patent and Exclusivity Information
24MG
Marketing Status: Prescription
Active Ingredient: DEUTETRABENAZINE
Proprietary Name: AUSTEDO XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 24MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N216354
Product Number: 003
Approval Date: Feb 17, 2023
Applicant Holder Full Name: TEVA NEUROSCIENCE INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: AUSTEDO XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 24MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N216354
Product Number: 003
Approval Date: Feb 17, 2023
Applicant Holder Full Name: TEVA NEUROSCIENCE INC
Marketing Status: Prescription
Patent and Exclusivity Information