General MedicationsORALStandard
FINTEPLA
FENFLURAMINE HYDROCHLORIDE
Standard Dose
EQ 2.2MG BASE/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview FINTEPLA is listed in Drugs@FDA under application 212102 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient FENFLURAMINE HYDROCHLORIDE Form and strength SOLUTION;ORAL - EQ 2.2MG BASE/ML Sponsor UCB INC Submission history Latest submission status date: 2025-10-15 00:00:00.
Structured Monograph
Clinical summary
Approval overview FINTEPLA is listed in Drugs@FDA under application 212102 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient FENFLURAMINE HYDROCHLORIDE Form and strength SOLUTION;ORAL - EQ 2.2MG BASE/ML Sponsor UCB INC Submission history Latest submission status date: 2025-10-15 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.