Application 214324
- Type
- NDA
- Sponsor
- UNITED THERAP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TYVASO DPI | TREPROSTINIL | POWDER;INHALATION | 16MCG | Yes | No |
| 002 | TYVASO DPI | TREPROSTINIL | POWDER;INHALATION | 0.032MG/INH | Yes | Yes |
| 003 | TYVASO DPI | TREPROSTINIL | POWDER;INHALATION | 0.048MG/INH | Yes | Yes |
| 004 | TYVASO DPI | TREPROSTINIL | POWDER;INHALATION | 0.064MG/INH | Yes | Yes |
| 005 | TYVASO DPI | TREPROSTINIL | POWDER;INHALATION | 0.08MG/INH | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N214324-001 | TYVASO DPI | TREPROSTINIL | 0.016MG/INH | POWDER / INHALATION | RLD, RS | 2022-05-23 | |
| N214324-002 | TYVASO DPI | TREPROSTINIL | 0.032MG/INH | POWDER / INHALATION | RLD, RS | 2022-05-23 | |
| N214324-003 | TYVASO DPI | TREPROSTINIL | 0.048MG/INH | POWDER / INHALATION | RLD, RS | 2022-05-23 | |
| N214324-004 | TYVASO DPI | TREPROSTINIL | 0.064MG/INH | POWDER / INHALATION | RLD, RS | 2022-05-23 | |
| N214324-005 | TYVASO DPI | TREPROSTINIL | 0.08MG/INH | POWDER / INHALATION | RLD, RS | 2024-10-24 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N214324-001 | 11357782 | 2027-05-14 | U-1849 | 2025-04-24 | |
| N214324-001 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | |
| N214324-001 | 9593066 | 2028-12-15 | Drug substance | 2022-06-17 | |
| N214324-001 | 10772883 | 2030-06-11 | Drug product | 2022-06-17 | |
| N214324-001 | 10421729 | 2035-04-01 | Drug product | 2022-06-17 | |
| N214324-001 | 11826327 | 2042-02-03 | U-3749 | 2023-11-28 | |
| N214324-002 | 11357782 | 2027-05-14 | U-1849 | 2025-04-24 | |
| N214324-002 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | |
| N214324-002 | 9593066 | 2028-12-15 | Drug substance | 2022-06-17 | |
| N214324-002 | 10772883 | 2030-06-11 | Drug product | 2022-06-17 | |
| N214324-002 | 10421729 | 2035-04-01 | Drug product | 2022-06-17 | |
| N214324-002 | 11826327 | 2042-02-03 | U-3749 | 2023-11-28 | |
| N214324-003 | 11357782 | 2027-05-14 | U-1849 | 2025-04-24 | |
| N214324-003 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | |
| N214324-003 | 9593066 | 2028-12-15 | Drug substance | 2022-06-17 | |
| N214324-003 | 10772883 | 2030-06-11 | Drug product | 2022-06-17 | |
| N214324-003 | 10421729 | 2035-04-01 | Drug product | 2022-06-17 | |
| N214324-003 | 11826327 | 2042-02-03 | U-3749 | 2023-11-28 | |
| N214324-004 | 11357782 | 2027-05-14 | U-1849 | 2025-04-24 | |
| N214324-004 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | |
| N214324-004 | 9593066 | 2028-12-15 | Drug substance | 2022-06-17 | |
| N214324-004 | 10772883 | 2030-06-11 | Drug product | 2022-06-17 | |
| N214324-004 | 10421729 | 2035-04-01 | Drug product | 2022-06-17 | |
| N214324-004 | 11826327 | 2042-02-03 | U-3749 | 2023-11-28 | |
| N214324-005 | 11357782 | 2027-05-14 | U-1849 | 2025-04-24 | |
| N214324-005 | 11723887 | 2028-12-15 | Drug substance | 2024-11-18 | |
| N214324-005 | 9593066 | 2028-12-15 | Drug substance | 2024-11-18 | |
| N214324-005 | 10772883 | 2030-06-11 | Drug product | 2024-11-18 | |
| N214324-005 | 10421729 | 2035-04-01 | Drug product | 2024-11-18 | |
| N214324-005 | 11826327 | 2042-02-03 | U-3749 | 2024-11-18 |
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 | 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 | N214324-001 | TYVASO DPI | 0.016MG/INH | POWDER / INHALATION | RLD, RS | 2022-05-23 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-002 | TYVASO DPI | 0.032MG/INH | POWDER / INHALATION | RLD, RS | 2022-05-23 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-003 | TYVASO DPI | 0.048MG/INH | POWDER / INHALATION | RLD, RS | 2022-05-23 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-004 | TYVASO DPI | 0.064MG/INH | POWDER / INHALATION | RLD, RS | 2022-05-23 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-005 | TYVASO DPI | 0.08MG/INH | POWDER / INHALATION | RLD, RS | 2024-10-24 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N214324-001 | 11357782 | 2027-05-14 | U-1849 | 2025-04-24 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-001 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-001 | 9593066 | 2028-12-15 | Drug substance | 2022-06-17 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-001 | 10772883 | 2030-06-11 | Drug product | 2022-06-17 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-001 | 10421729 | 2035-04-01 | Drug product | 2022-06-17 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-001 | 11826327 | 2042-02-03 | U-3749 | 2023-11-28 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-002 | 11357782 | 2027-05-14 | U-1849 | 2025-04-24 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-002 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-002 | 9593066 | 2028-12-15 | Drug substance | 2022-06-17 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-002 | 10772883 | 2030-06-11 | Drug product | 2022-06-17 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-002 | 10421729 | 2035-04-01 | Drug product | 2022-06-17 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-002 | 11826327 | 2042-02-03 | U-3749 | 2023-11-28 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-003 | 11357782 | 2027-05-14 | U-1849 | 2025-04-24 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-003 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-003 | 9593066 | 2028-12-15 | Drug substance | 2022-06-17 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-003 | 10772883 | 2030-06-11 | Drug product | 2022-06-17 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-003 | 10421729 | 2035-04-01 | Drug product | 2022-06-17 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-003 | 11826327 | 2042-02-03 | U-3749 | 2023-11-28 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-004 | 11357782 | 2027-05-14 | U-1849 | 2025-04-24 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-004 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-004 | 9593066 | 2028-12-15 | Drug substance | 2022-06-17 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-004 | 10772883 | 2030-06-11 | Drug product | 2022-06-17 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-004 | 10421729 | 2035-04-01 | Drug product | 2022-06-17 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-004 | 11826327 | 2042-02-03 | U-3749 | 2023-11-28 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-005 | 11357782 | 2027-05-14 | U-1849 | 2025-04-24 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-005 | 11723887 | 2028-12-15 | Drug substance | 2024-11-18 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-005 | 9593066 | 2028-12-15 | Drug substance | 2024-11-18 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-005 | 10772883 | 2030-06-11 | Drug product | 2024-11-18 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-005 | 10421729 | 2035-04-01 | Drug product | 2024-11-18 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | N214324-005 | 11826327 | 2042-02-03 | U-3749 | 2024-11-18 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Tyvaso DPI | TREPROSTINIL | United Therapeutics Corporation | ddc3d400-bcb3-4b09-aae2-0768b10a5b0f | 2025-11-20 | Warnings, Adverse reactions | 214324 NDA214324 66302-764 66302-648 66302-616 66302-732 66302-716 66302-748 66302-620 66302-632 66302-600 66302-664 66302-610 66302-720 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 66302-600 | Tyvaso DPI | treprostinil | United Therapeutics Corporation | NDA | Current |
| 66302-610 | Tyvaso DPI | treprostinil | United Therapeutics Corporation | NDA | Current |
| 66302-616 | Tyvaso DPI | treprostinil | United Therapeutics Corporation | NDA | Current |
| 66302-620 | Tyvaso DPI | treprostinil | United Therapeutics Corporation | NDA | Current |
| 66302-632 | Tyvaso DPI | treprostinil | United Therapeutics Corporation | NDA | Current |
| 66302-648 | Tyvaso DPI | treprostinil | United Therapeutics Corporation | NDA | Current |
| 66302-664 | Tyvaso DPI | treprostinil | United Therapeutics Corporation | NDA | Current |
| 66302-716 | Tyvaso DPI | treprostinil | United Therapeutics Corporation | NDA | Current |
| 66302-720 | Tyvaso DPI | treprostinil | United Therapeutics Corporation | NDA | Current |
| 66302-732 | Tyvaso DPI | treprostinil | United Therapeutics Corporation | NDA | Current |
| 66302-748 | Tyvaso DPI | treprostinil | United Therapeutics Corporation | NDA | Current |
| 66302-764 | Tyvaso DPI | treprostinil | United Therapeutics Corporation | NDA | Current |