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FDA NDA · NDA022387

TYVASO

treprostinil

Sponsor: UNITED THERAP

APPLICATION
NDA022387
TYPE
NDA
ORIGINAL APPROVAL
2009-07-30
LATEST ACTION
2026-04-03
ROUTE
ORAL, INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

TYVASO · ReferencePrescription
TREPROSTINIL 0.6MG/ML · SOLUTION · INHALATION

Approval history

2026-04-03Labeling · Supplement 28 · standard — Letter ↗AP
2022-05-20Labeling · Supplement 20 · standard — Letter ↗AP
2021-03-31Efficacy · Supplement 17 · standard — Label ↗AP
2017-10-19Efficacy · Supplement 15 · standard — Letter ↗AP
2016-06-06Labeling · Supplement 14 · standard — Letter ↗AP
2015-06-23Manufacturing (CMC) · Supplement 12 · standardAP
2014-08-01Labeling · Supplement 11 · standardAP
2014-05-20Efficacy · Supplement 9 · standard — Label ↗AP
2013-04-30Labeling · Supplement 8 · standard — Letter ↗AP
2013-01-07Manufacturing (CMC) · Supplement 7 · standardAP
2011-02-08Labeling · Supplement 4 · unknown — Letter ↗AP
2009-07-30Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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