← FDA DRUG APPROVALS

FDA NDA · NDA213005

YUTREPIA

treprostinil

Sponsor: LIQUIDIA TECH

APPLICATION
NDA213005
TYPE
NDA
ORIGINAL APPROVAL
2025-05-23
LATEST ACTION
2025-05-23
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

YUTREPIA · ReferencePrescription
TREPROSTINIL SODIUM EQ 0.0795MG BASE/INH · POWDER · INHALATION
YUTREPIA · ReferencePrescription
TREPROSTINIL SODIUM EQ 0.0265MG BASE/INH · POWDER · INHALATION
YUTREPIA · ReferencePrescription
TREPROSTINIL SODIUM EQ 0.106MG BASE/INH · POWDER · INHALATION
YUTREPIA · ReferencePrescription
TREPROSTINIL SODIUM EQ 0.053MG BASE/INH · POWDER · INHALATION

Approval history

2025-05-23Type 5 - New Formulation or New Manufacturer · 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.

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