Application 208276
- Type
- NDA
- Sponsor
- UNITED THERAP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | REMODULIN | TREPROSTINIL | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 20MG/20ML (1MG/ML) | No | No |
| 002 | REMODULIN | TREPROSTINIL | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 50MG/20ML (2.5MG/ML) | No | No |
| 003 | REMODULIN | TREPROSTINIL | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 100MG/20ML (5MG/ML) | No | No |
| 004 | REMODULIN | TREPROSTINIL | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 200MG/20ML (10MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N208276-001 | REMODULIN | TREPROSTINIL | 20MG/20ML (1MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | ||
| N208276-002 | REMODULIN | TREPROSTINIL | 50MG/20ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | ||
| N208276-003 | REMODULIN | TREPROSTINIL | 100MG/20ML (5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | ||
| N208276-004 | REMODULIN | TREPROSTINIL | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N208276-001 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | |
| N208276-002 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | |
| N208276-003 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | |
| N208276-004 | 9593066 | 2028-12-15 | Drug substance | 2018-10-01 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N208276-001 | REMODULIN | 20MG/20ML (1MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N208276-002 | REMODULIN | 50MG/20ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N208276-003 | REMODULIN | 100MG/20ML (5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N208276-004 | REMODULIN | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208276-001 | REMODULIN | 20MG/20ML (1MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208276-002 | REMODULIN | 50MG/20ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208276-003 | REMODULIN | 100MG/20ML (5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N208276-004 | REMODULIN | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208276-001 | REMODULIN | 20MG/20ML (1MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208276-002 | REMODULIN | 50MG/20ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208276-003 | REMODULIN | 100MG/20ML (5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208276-004 | REMODULIN | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N208276-001 | REMODULIN | 20MG/20ML (1MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N208276-002 | REMODULIN | 50MG/20ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N208276-003 | REMODULIN | 100MG/20ML (5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N208276-004 | REMODULIN | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208276-001 | REMODULIN | 20MG/20ML (1MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208276-002 | REMODULIN | 50MG/20ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208276-003 | REMODULIN | 100MG/20ML (5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208276-004 | REMODULIN | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208276-001 | REMODULIN | 20MG/20ML (1MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208276-002 | REMODULIN | 50MG/20ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208276-003 | REMODULIN | 100MG/20ML (5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208276-004 | REMODULIN | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208276-001 | REMODULIN | 20MG/20ML (1MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208276-002 | REMODULIN | 50MG/20ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208276-003 | REMODULIN | 100MG/20ML (5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208276-004 | REMODULIN | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208276-001 | REMODULIN | 20MG/20ML (1MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208276-002 | REMODULIN | 50MG/20ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208276-003 | REMODULIN | 100MG/20ML (5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208276-004 | REMODULIN | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208276-001 | REMODULIN | 20MG/20ML (1MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208276-002 | REMODULIN | 50MG/20ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208276-003 | REMODULIN | 100MG/20ML (5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208276-004 | REMODULIN | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208276-001 | REMODULIN | 20MG/20ML (1MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208276-002 | REMODULIN | 50MG/20ML (2.5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208276-003 | REMODULIN | 100MG/20ML (5MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208276-004 | REMODULIN | 200MG/20ML (10MG/ML) | SOLUTION / INTRAVENOUS, SUBCUTANEOUS | 2018-07-30 | d8e5a09893c0… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N208276-001 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208276-002 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208276-003 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208276-004 | 9593066 | 2028-12-15 | Drug substance | 2018-10-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208276-001 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208276-002 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208276-003 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208276-004 | 9593066 | 2028-12-15 | Drug substance | 2018-10-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208276-001 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208276-002 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208276-003 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208276-004 | 9593066 | 2028-12-15 | Drug substance | 2018-10-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208276-001 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208276-002 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208276-003 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208276-004 | 9593066 | 2028-12-15 | Drug substance | 2018-10-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208276-001 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208276-002 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208276-003 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208276-004 | 9593066 | 2028-12-15 | Drug substance | 2018-10-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208276-001 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208276-002 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208276-003 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208276-004 | 9593066 | 2028-12-15 | Drug substance | 2018-10-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208276-001 | 10076505 | 2024-12-16 | Drug product | 2018-11-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208276-001 | 9713599 | 2024-12-16 | U-2036 | 2018-11-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208276-001 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208276-002 | 10076505 | 2024-12-16 | Drug product | 2018-11-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208276-002 | 9713599 | 2024-12-16 | U-2036 | 2018-11-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208276-002 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208276-003 | 10076505 | 2024-12-16 | Drug product | 2018-11-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208276-003 | 9713599 | 2024-12-16 | U-2036 | 2018-11-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208276-003 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208276-004 | 10076505 | 2024-12-16 | Drug product | 2018-10-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208276-004 | 9713599 | 2024-12-16 | U-2036 | 2018-10-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208276-004 | 9593066 | 2028-12-15 | Drug substance | 2018-10-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208276-001 | 10076505 | 2024-12-16 | Drug product | 2018-11-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208276-001 | 9713599 | 2024-12-16 | U-2036 | 2018-11-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208276-001 | 9593066 | 2028-12-15 | Drug substance | 2018-11-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208276-002 | 10076505 | 2024-12-16 | Drug product | 2018-11-02 | 2680178bc6a6… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Remodulin | TREPROSTINIL | United Therapeutics Corporation | 6c80bb38-e8db-4138-9f0d-dbbf9c673185 | 2026-07-02 | Warnings, Adverse reactions | Remodulin TREPROSTINIL |
| TYVASO | TREPROSTINIL | United Therapeutics Corporation | cbc31ab1-a80f-4b50-a3b1-39910b0fb609 | 2026-04-14 | Warnings, Adverse reactions | TREPROSTINIL |
| Tyvaso DPI | TREPROSTINIL | United Therapeutics Corporation | ddc3d400-bcb3-4b09-aae2-0768b10a5b0f | 2025-11-20 | Warnings, Adverse reactions | TREPROSTINIL |
| Yutrepia | TREPROSTINIL | Liquidia Technologies, Inc. | e8f6d534-115c-440e-bdbb-b443a29bb468 | 2025-09-08 | Warnings, Adverse reactions | TREPROSTINIL |
| Treprostinil | TREPROSTINIL | Alembic Pharmaceuticals Inc. | 4a684b13-669d-4721-8ed4-30cc7762b0b8 | 2025-02-13 | Warnings, Adverse reactions | TREPROSTINIL |
| Orenitram | TREPROSTINIL | United Therapeutics Corporation | 8ed2003a-c801-411e-831e-d06079bb0d7c | 2024-11-20 | Warnings, Adverse reactions | TREPROSTINIL |
| Treprostinil | TREPROSTINIL | Sandoz Inc | 473297ca-a872-4052-a053-87dc8f0d3c13 | 2023-04-06 | Warnings, Adverse reactions | TREPROSTINIL |
| Treprostinil | TREPROSTINIL | Teva Parenteral Medicines, Inc. | 4b2ce4aa-4302-49db-9456-c8cf0e034968 | 2022-05-01 | Warnings, Adverse reactions | TREPROSTINIL |
| Sterile Diluent for Treprostinil | WATER | Dr.Reddy's Laboratories Inc., | 33050ee2-519b-1f0b-d4df-9e14dd329c57 | 2021-12-23 | Warnings, Adverse reactions | TREPROSTINIL |