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FDA NDA · NDA214517

HETLIOZ LQ

tasimelteon

Sponsor: VANDA PHARMS INC

APPLICATION
NDA214517
TYPE
NDA
ORIGINAL APPROVAL
2020-12-01
LATEST ACTION
2020-12-01
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

HETLIOZ LQPrescription
TASIMELTEON 4MG/ML · SUSPENSION · ORAL
HETLIOZ LQ · ReferencePrescription
TASIMELTEON 4MG/ML · SUSPENSION · ORAL

Approval history

2020-12-01Type 3 - New Dosage Form · Original · priority — Label ↗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.

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