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 42 .
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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022387-001 TYVASO 0.6MG/ML SOLUTION / INHALATION RLD, RS 2009-07-30 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 7 · 272 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N022387-001 10376525 2027-05-14 U-1849 2020-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022387-001 9339507 2028-03-10 Drug product 2016-05-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022387-001 9358240 2028-05-05 U-1849 2016-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022387-001 11723887 2028-12-15 Drug substance 2023-08-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022387-001 9593066 2028-12-15 Drug substance 2017-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022387-001 11826327 2042-02-03 U-3749 2023-11-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022387-001 10376525 2027-05-14 U-1849 2020-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022387-001 9339507 2028-03-10 Drug product 2016-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022387-001 9358240 2028-05-05 U-1849 2016-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022387-001 11723887 2028-12-15 Drug substance 2023-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022387-001 9593066 2028-12-15 Drug substance 2017-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022387-001 11826327 2042-02-03 U-3749 2023-11-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022387-001 10376525 2027-05-14 U-1849 2020-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022387-001 9339507 2028-03-10 Drug product 2016-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022387-001 9358240 2028-05-05 U-1849 2016-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022387-001 11723887 2028-12-15 Drug substance 2023-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022387-001 9593066 2028-12-15 Drug substance 2017-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022387-001 11826327 2042-02-03 U-3749 2023-11-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022387-001 10376525 2027-05-14 U-1849 2020-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022387-001 9339507 2028-03-10 Drug product 2016-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022387-001 9358240 2028-05-05 U-1849 2016-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022387-001 11723887 2028-12-15 Drug substance 2023-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022387-001 9593066 2028-12-15 Drug substance 2017-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022387-001 11826327 2042-02-03 U-3749 2023-11-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022387-001 10376525 2027-05-14 U-1849 2020-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022387-001 9339507 2028-03-10 Drug product 2016-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022387-001 9358240 2028-05-05 U-1849 2016-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022387-001 11723887 2028-12-15 Drug substance 2023-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022387-001 9593066 2028-12-15 Drug substance 2017-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022387-001 11826327 2042-02-03 U-3749 2023-11-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022387-001 10376525 2027-05-14 U-1849 2020-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022387-001 9339507 2028-03-10 Drug product 2016-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022387-001 9358240 2028-05-05 U-1849 2016-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022387-001 11723887 2028-12-15 Drug substance 2023-08-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022387-001 9593066 2028-12-15 Drug substance 2017-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022387-001 11826327 2042-02-03 U-3749 2023-11-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022387-001 10376525 2027-05-14 U-1849 2020-04-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022387-001 9339507 2028-03-10 Drug product 2016-05-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022387-001 9358240 2028-05-05 U-1849 2016-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022387-001 11723887 2028-12-15 Drug substance 2023-08-15 03ed91905a0d…
Observed Orange Book exclusivity history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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