← FDA DRUG APPROVALS

FDA NDA · NDA214962

TASCENSO ODT

fingolimod lauryl sulfate

Sponsor: CYCLE

APPLICATION
NDA214962
TYPE
NDA
ORIGINAL APPROVAL
2021-12-23
LATEST ACTION
2026-06-29
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription

Products

TASCENSO ODT · ReferencePrescription
FINGOLIMOD LAURYL SULFATE EQ 0.25MG BASE · TABLET, ORALLY DISINTEGRATING · ORAL
TASCENSO ODT · ReferencePrescription
FINGOLIMOD LAURYL SULFATE EQ 0.5MG BASE · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2026-06-29Labeling · Supplement 5 · standard — Letter ↗AP
2025-01-28Labeling · Supplement 3 · standard — Label ↗AP
2024-06-05Labeling · Supplement 2 · standard — Label ↗AP
2023-08-10Labeling · Supplement 1 · standard — Letter ↗AP
2022-12-09Type 2 - New Active Ingredient · Original · standard — Label ↗AP
2021-12-23UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →