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FDA NDA · NDA214324

TYVASO DPI

treprostinil

Sponsor: UNITED THERAP

APPLICATION
NDA214324
TYPE
NDA
ORIGINAL APPROVAL
2022-05-23
LATEST ACTION
2022-05-23
ROUTE
ORAL, INHALATION
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

TYVASO DPI · ReferencePrescription
TREPROSTINIL 0.08MG/INH · POWDER · INHALATION
TYVASO DPI · ReferencePrescription
TREPROSTINIL 0.048MG/INH · POWDER · INHALATION
TYVASO DPI · ReferencePrescription
TREPROSTINIL 0.016MG/INH · POWDER · INHALATION
TYVASO DPI · ReferencePrescription
TREPROSTINIL 0.064MG/INH · POWDER · INHALATION
TYVASO DPI · ReferencePrescription
TREPROSTINIL 0.032MG/INH · POWDER · INHALATION

Approval history

2022-05-23Type 5 - New Formulation or New Manufacturer · 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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