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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212102

FINTEPLA (FENFLURAMINE HYDROCHLORIDE)
EQ 2.2MG BASE/ML
Marketing Status: Prescription
Active Ingredient: FENFLURAMINE HYDROCHLORIDE
Proprietary Name: FINTEPLA
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: EQ 2.2MG BASE/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212102
Product Number: 001
Approval Date: Jun 25, 2020
Applicant Holder Full Name: UCB INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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