Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208082

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AUSTEDO (DEUTETRABENAZINE)
6MG
Marketing Status: Prescription

Active Ingredient: DEUTETRABENAZINE
Proprietary Name: AUSTEDO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 6MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208082
Product Number: 001
Approval Date: Apr 3, 2017
Applicant Holder Full Name: TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
Marketing Status:  Prescription
Patent and Exclusivity Information

AUSTEDO (DEUTETRABENAZINE)
9MG
Marketing Status: Prescription

Active Ingredient: DEUTETRABENAZINE
Proprietary Name: AUSTEDO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 9MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208082
Product Number: 002
Approval Date: Apr 3, 2017
Applicant Holder Full Name: TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
Marketing Status:  Prescription
Patent and Exclusivity Information

AUSTEDO (DEUTETRABENAZINE)
12MG
Marketing Status: Prescription

Active Ingredient: DEUTETRABENAZINE
Proprietary Name: AUSTEDO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208082
Product Number: 003
Approval Date: Apr 3, 2017
Applicant Holder Full Name: TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
Marketing Status:  Prescription
Patent and Exclusivity Information