Home Applications 022387 Application 022387
Type NDA
Sponsor UNITED THERAP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TYVASO TREPROSTINIL SOLUTION;INHALATION 0.6MG/ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022387-001 TYVASO TREPROSTINIL 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022387-001 10376525 2027-05-14 U-1849 2020-04-29 N022387-001 9339507 2028-03-10 Drug product 2016-05-17 N022387-001 9358240 2028-05-05 U-1849 2016-06-08 N022387-001 11723887 2028-12-15 Drug substance 2023-08-15 N022387-001 9593066 2028-12-15 Drug substance 2017-03-14 N022387-001 11826327 2042-02-03 U-3749 2023-11-28
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N022387-001 10376525 2027-05-14 U-1849 2020-04-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N022387-001 9339507 2028-03-10 Drug product 2016-05-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N022387-001 9358240 2028-05-05 U-1849 2016-06-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N022387-001 11723887 2028-12-15 Drug substance 2023-08-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N022387-001 9593066 2028-12-15 Drug substance 2017-03-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N022387-001 11826327 2042-02-03 U-3749 2023-11-28 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TYVASO TREPROSTINIL United Therapeutics Corporation cbc31ab1-a80f-4b50-a3b1-39910b0fb609 2026-04-14 Warnings, Adverse reactions Exact identifier application applno (NDA): 022387 application number: NDA022387 ndc (product): 66302-206
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 66302-206 TYVASO treprostinil United Therapeutics Corporation NDA Current 66302-206 TYVASO treprostinil United Therapeutics Corporation NDA Current 66302-206 TYVASO treprostinil United Therapeutics Corporation NDA Current 66302-206 TYVASO treprostinil United Therapeutics Corp. NDA Current 66302-206 TYVASO treprostinil United Therapeutics Corp. NDA Current