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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 206093

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TETRABENAZINE (TETRABENAZINE)
12.5MG
Marketing Status: Prescription
Active Ingredient: TETRABENAZINE
Proprietary Name: TETRABENAZINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206093
Product Number: 001
Approval Date: Mar 17, 2020
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information
TETRABENAZINE (TETRABENAZINE)
25MG
Marketing Status: Prescription
Active Ingredient: TETRABENAZINE
Proprietary Name: TETRABENAZINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206093
Product Number: 002
Approval Date: Mar 17, 2020
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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