← FDA DRUG APPROVALS

FDA NDA · NDA205677

HETLIOZ

tasimelteon

Sponsor: VANDA PHARMS INC

APPLICATION
NDA205677
TYPE
NDA
ORIGINAL APPROVAL
2014-01-31
LATEST ACTION
2026-07-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

HETLIOZ · ReferencePrescription
TASIMELTEON 20MG · CAPSULE · ORAL

Approval history

2026-07-27Manufacturing (CMC) · Supplement 13 — Label ↗AP
2020-12-01Efficacy · Supplement 7 · priority — Label ↗AP
2019-10-07Labeling · Supplement 6 · standard — Label ↗AP
2016-04-11Manufacturing (CMC) · Supplement 2 · priorityAP
2014-12-12Labeling · Supplement 1 · standard — Label ↗AP
2014-01-31Type 1 - New Molecular Entity · Original · priority — Label ↗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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