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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 210196

VIGADRONE (VIGABATRIN)
500MG/PACKET
Marketing Status: Prescription
Active Ingredient: VIGABATRIN
Proprietary Name: VIGADRONE
Dosage Form; Route of Administration: FOR SOLUTION; ORAL
Strength: 500MG/PACKET
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A210196
Product Number: 001
Approval Date: Jun 21, 2018
Applicant Holder Full Name: AUCTA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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