Application 215908
- Type
- ANDA
- Sponsor
- TORRENT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NITISINONE | NITISINONE | CAPSULE;ORAL | 2MG | No | No |
| 002 | NITISINONE | NITISINONE | CAPSULE;ORAL | 5MG | No | No |
| 003 | NITISINONE | NITISINONE | CAPSULE;ORAL | 10MG | No | No |
| 004 | NITISINONE | NITISINONE | CAPSULE;ORAL | 20MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215908-001 | NITISINONE | NITISINONE | 2MG | CAPSULE / ORAL | 2023-01-09 | ||
| A215908-002 | NITISINONE | NITISINONE | 5MG | CAPSULE / ORAL | 2023-01-09 | ||
| A215908-003 | NITISINONE | NITISINONE | 10MG | CAPSULE / ORAL | 2023-01-09 | ||
| A215908-004 | NITISINONE | NITISINONE | 20MG | CAPSULE / ORAL | 2023-01-09 |
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 | A215908-001 | NITISINONE | 2MG | CAPSULE / ORAL | 2023-01-09 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A215908-002 | NITISINONE | 5MG | CAPSULE / ORAL | 2023-01-09 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A215908-003 | NITISINONE | 10MG | CAPSULE / ORAL | 2023-01-09 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A215908-004 | NITISINONE | 20MG | CAPSULE / ORAL | 2023-01-09 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A215908-001 | NITISINONE | 2MG | CAPSULE / ORAL | 2023-01-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A215908-002 | NITISINONE | 5MG | CAPSULE / ORAL | 2023-01-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A215908-003 | NITISINONE | 10MG | CAPSULE / ORAL | 2023-01-09 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A215908-004 | NITISINONE | 20MG | CAPSULE / ORAL | 2023-01-09 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215908-001 | NITISINONE | 2MG | CAPSULE / ORAL | 2023-01-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215908-002 | NITISINONE | 5MG | CAPSULE / ORAL | 2023-01-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215908-003 | NITISINONE | 10MG | CAPSULE / ORAL | 2023-01-09 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A215908-004 | NITISINONE | 20MG | CAPSULE / ORAL | 2023-01-09 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A215908-001 | NITISINONE | 2MG | CAPSULE / ORAL | 2023-01-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A215908-002 | NITISINONE | 5MG | CAPSULE / ORAL | 2023-01-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A215908-003 | NITISINONE | 10MG | CAPSULE / ORAL | 2023-01-09 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A215908-004 | NITISINONE | 20MG | CAPSULE / ORAL | 2023-01-09 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215908-001 | NITISINONE | 2MG | CAPSULE / ORAL | 2023-01-09 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215908-002 | NITISINONE | 5MG | CAPSULE / ORAL | 2023-01-09 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215908-003 | NITISINONE | 10MG | CAPSULE / ORAL | 2023-01-09 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A215908-004 | NITISINONE | 20MG | CAPSULE / ORAL | 2023-01-09 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215908-001 | NITISINONE | 2MG | CAPSULE / ORAL | 2023-01-09 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215908-002 | NITISINONE | 5MG | CAPSULE / ORAL | 2023-01-09 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215908-003 | NITISINONE | 10MG | CAPSULE / ORAL | 2023-01-09 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A215908-004 | NITISINONE | 20MG | CAPSULE / ORAL | 2023-01-09 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215908-001 | NITISINONE | 2MG | CAPSULE / ORAL | 2023-01-09 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215908-002 | NITISINONE | 5MG | CAPSULE / ORAL | 2023-01-09 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215908-003 | NITISINONE | 10MG | CAPSULE / ORAL | 2023-01-09 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A215908-004 | NITISINONE | 20MG | CAPSULE / ORAL | 2023-01-09 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215908-001 | NITISINONE | 2MG | CAPSULE / ORAL | 2023-01-09 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215908-002 | NITISINONE | 5MG | CAPSULE / ORAL | 2023-01-09 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215908-003 | NITISINONE | 10MG | CAPSULE / ORAL | 2023-01-09 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A215908-004 | NITISINONE | 20MG | CAPSULE / ORAL | 2023-01-09 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215908-001 | NITISINONE | 2MG | CAPSULE / ORAL | 2023-01-09 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215908-002 | NITISINONE | 5MG | CAPSULE / ORAL | 2023-01-09 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215908-003 | NITISINONE | 10MG | CAPSULE / ORAL | 2023-01-09 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A215908-004 | NITISINONE | 20MG | CAPSULE / ORAL | 2023-01-09 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215908-001 | NITISINONE | 2MG | CAPSULE / ORAL | 2023-01-09 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215908-002 | NITISINONE | 5MG | CAPSULE / ORAL | 2023-01-09 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215908-003 | NITISINONE | 10MG | CAPSULE / ORAL | 2023-01-09 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A215908-004 | NITISINONE | 20MG | CAPSULE / ORAL | 2023-01-09 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215908-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215908-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215908-003 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A215908-004 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A215908-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A215908-002 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A215908-003 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A215908-004 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A215908-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A215908-002 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A215908-003 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A215908-004 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215908-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215908-002 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215908-003 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215908-004 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215908-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215908-002 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215908-003 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215908-004 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215908-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215908-002 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215908-003 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A215908-004 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215908-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215908-002 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215908-003 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A215908-004 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A215908-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A215908-002 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A215908-003 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A215908-004 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A215908-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A215908-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A215908-003 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A215908-004 | AB | 1 | 3bdfa0b2c4d7… |
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 |
|---|---|---|---|---|---|---|
| Nitisinone | NITISINONE | Par Health USA, LLC | 437868f5-1c9e-4b0f-8a03-77df8ac0900d | 2026-08-06 | Warnings, Adverse reactions | Nitisinone NITISINONE |
| NITYR | NITISINONE | Cycle Pharmaceuticals Ltd. | 00fd1905-27e4-420e-8dc5-a69e4ddc1526 | 2025-12-22 | Warnings, Adverse reactions | NITISINONE |
| ORFADIN | NITISINONE | Swedish Orphan Biovitrum AB (publ) | 00307f42-748d-4227-8c6f-ed5f0a89ae0a | 2025-12-18 | Warnings, Adverse reactions | NITISINONE |
| Nitisinone | NITISINONE | Analog Pharma | 645c8387-30d5-4a86-a5d8-2f6b5df6d5f0 | 2025-09-05 | Warnings, Adverse reactions | Nitisinone NITISINONE |
| HARLIKU | NITISINONE | Cycle Pharmaceuticals Ltd. | 7cf67e24-d46b-4376-bbd0-0b973c406d0d | 2025-06-02 | Warnings, Adverse reactions | NITISINONE |
| Nitisinone | NITISINONE | Eton Pharmaceuticals, Inc. | dc5e4875-fcd7-408c-88c9-4a715f4384b6 | 2024-02-02 | Warnings, Adverse reactions | Nitisinone NITISINONE |
| Nitisinone | NITISINONE | Bryant Ranch Prepack | c1b3adc8-02fa-4e22-8c05-8f32b586e53f | 2024-01-10 | Warnings, Adverse reactions | Nitisinone NITISINONE |
| Nitisinone | NITISINONE | Bryant Ranch Prepack | 8cec0318-9f55-4340-b14b-588635619251 | 2024-01-10 | Warnings, Adverse reactions | Nitisinone NITISINONE |
| Nitisinone | NITISINONE | Bryant Ranch Prepack | b7c38003-6899-4508-a69a-aef1231de22c | 2024-01-10 | Warnings, Adverse reactions | Nitisinone NITISINONE |
| Orfadin | NITISINONE | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | 5d449b73-d503-4132-b978-d890491975df | 2021-11-30 | Warnings, Adverse reactions | NITISINONE |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 73412 | ORIG | 2023-02-08 |