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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214679

EPRONTIA (TOPIRAMATE)
25MG/ML
Marketing Status: Prescription
Active Ingredient: TOPIRAMATE
Proprietary Name: EPRONTIA
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 25MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214679
Product Number: 001
Approval Date: Nov 5, 2021
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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