← FDA DRUG APPROVALS

FDA NDA · NDA212102

FINTEPLA

fenfluramine

Sponsor: UCB INC

APPLICATION
NDA212102
TYPE
NDA
ORIGINAL APPROVAL
2020-06-25
LATEST ACTION
2026-05-22
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

FINTEPLA · ReferencePrescription
FENFLURAMINE HYDROCHLORIDE EQ 2.2MG BASE/ML · SOLUTION · ORAL

Approval history

2026-05-22REMS · Supplement 18 — Letter ↗AP
2025-10-15Labeling · Supplement 17 · standard — Letter ↗AP
2025-04-08Labeling · Supplement 16 · standard — Label ↗AP
2024-04-02REMS · Supplement 14 — Letter ↗AP
2023-12-11Labeling · Supplement 13 · standard — Label ↗AP
2023-09-14Labeling · Supplement 7 · standard — Letter ↗AP
2023-09-14Labeling · Supplement 8 · standard — Letter ↗AP
2023-05-30REMS · Supplement 9 — Letter ↗AP
2023-01-03Labeling · Supplement 6 · standard — Letter ↗AP
2022-06-15Labeling · Supplement 5 · standard — Letter ↗AP
2022-03-25Efficacy · Supplement 3 · priority — Label ↗AP
2020-06-25Type 3 - New Dosage Form · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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