Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216354

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AUSTEDO XR (DEUTETRABENAZINE)
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)
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)
18MG
Marketing Status: Prescription

Active Ingredient: DEUTETRABENAZINE
Proprietary Name: AUSTEDO XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 18MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216354
Product Number: 008
Approval Date: Jul 1, 2024
Applicant Holder Full Name: TEVA NEUROSCIENCE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

AUSTEDO XR (DEUTETRABENAZINE)
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

AUSTEDO XR (DEUTETRABENAZINE)
30MG
Marketing Status: Prescription

Active Ingredient: DEUTETRABENAZINE
Proprietary Name: AUSTEDO XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216354
Product Number: 004
Approval Date: May 29, 2024
Applicant Holder Full Name: TEVA NEUROSCIENCE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

AUSTEDO XR (DEUTETRABENAZINE)
36MG
Marketing Status: Prescription

Active Ingredient: DEUTETRABENAZINE
Proprietary Name: AUSTEDO XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 36MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216354
Product Number: 005
Approval Date: May 29, 2024
Applicant Holder Full Name: TEVA NEUROSCIENCE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

AUSTEDO XR (DEUTETRABENAZINE)
42MG
Marketing Status: Prescription

Active Ingredient: DEUTETRABENAZINE
Proprietary Name: AUSTEDO XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 42MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216354
Product Number: 006
Approval Date: May 29, 2024
Applicant Holder Full Name: TEVA NEUROSCIENCE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

AUSTEDO XR (DEUTETRABENAZINE)
48MG
Marketing Status: Prescription

Active Ingredient: DEUTETRABENAZINE
Proprietary Name: AUSTEDO XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 48MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N216354
Product Number: 007
Approval Date: May 29, 2024
Applicant Holder Full Name: TEVA NEUROSCIENCE INC
Marketing Status:  Prescription
Patent and Exclusivity Information