Application 211837
- Type
- ANDA
- Sponsor
- TORRENT PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FEBUXOSTAT | FEBUXOSTAT | TABLET;ORAL | 40MG | No | No |
| 002 | FEBUXOSTAT | FEBUXOSTAT | TABLET;ORAL | 80MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211837-001 | FEBUXOSTAT | FEBUXOSTAT | 40MG | TABLET / ORAL | 2023-12-19 | ||
| A211837-002 | FEBUXOSTAT | FEBUXOSTAT | 80MG | TABLET / ORAL | 2023-12-19 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A211837-001 | FEBUXOSTAT | 40MG | TABLET / ORAL | 2023-12-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211837-002 | FEBUXOSTAT | 80MG | TABLET / ORAL | 2023-12-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211837-001 | FEBUXOSTAT | 40MG | TABLET / ORAL | 2023-12-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211837-002 | FEBUXOSTAT | 80MG | TABLET / ORAL | 2023-12-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211837-001 | FEBUXOSTAT | 40MG | TABLET / ORAL | 2023-12-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211837-002 | FEBUXOSTAT | 80MG | TABLET / ORAL | 2023-12-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211837-001 | FEBUXOSTAT | 40MG | TABLET / ORAL | 2023-12-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211837-002 | FEBUXOSTAT | 80MG | TABLET / ORAL | 2023-12-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211837-001 | FEBUXOSTAT | 40MG | TABLET / ORAL | 2023-12-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211837-002 | FEBUXOSTAT | 80MG | TABLET / ORAL | 2023-12-19 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211837-001 | FEBUXOSTAT | 40MG | TABLET / ORAL | 2023-12-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211837-002 | FEBUXOSTAT | 80MG | TABLET / ORAL | 2023-12-19 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211837-001 | FEBUXOSTAT | 40MG | TABLET / ORAL | 2023-12-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211837-002 | FEBUXOSTAT | 80MG | TABLET / ORAL | 2023-12-19 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211837-001 | FEBUXOSTAT | 40MG | TABLET / ORAL | 2023-12-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211837-002 | FEBUXOSTAT | 80MG | TABLET / ORAL | 2023-12-19 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211837-001 | FEBUXOSTAT | 40MG | TABLET / ORAL | 2023-12-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211837-002 | FEBUXOSTAT | 80MG | TABLET / ORAL | 2023-12-19 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211837-001 | FEBUXOSTAT | 40MG | TABLET / ORAL | 2023-12-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211837-002 | FEBUXOSTAT | 80MG | TABLET / ORAL | 2023-12-19 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211837-001 | FEBUXOSTAT | 40MG | TABLET / ORAL | 2023-12-19 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211837-002 | FEBUXOSTAT | 80MG | TABLET / ORAL | 2023-12-19 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211837-001 | FEBUXOSTAT | 40MG | TABLET / ORAL | 2023-12-19 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211837-002 | FEBUXOSTAT | 80MG | TABLET / ORAL | 2023-12-19 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211837-001 | FEBUXOSTAT | 40MG | TABLET / ORAL | 2023-12-19 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211837-002 | FEBUXOSTAT | 80MG | TABLET / ORAL | 2023-12-19 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211837-001 | FEBUXOSTAT | 40MG | TABLET / ORAL | 2023-12-19 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211837-002 | FEBUXOSTAT | 80MG | TABLET / ORAL | 2023-12-19 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211837-001 | FEBUXOSTAT | 40MG | TABLET / ORAL | 2023-12-19 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211837-002 | FEBUXOSTAT | 80MG | TABLET / ORAL | 2023-12-19 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A211837-001 | FEBUXOSTAT | 40MG | TABLET / ORAL | 2023-12-19 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A211837-002 | FEBUXOSTAT | 80MG | TABLET / ORAL | 2023-12-19 | 1c564ffb4f44… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211837-001 | FEBUXOSTAT | 40MG | TABLET / ORAL | 2023-12-19 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211837-002 | FEBUXOSTAT | 80MG | TABLET / ORAL | 2023-12-19 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| febuxostat | FEBUXOSTAT | REMEDYREPACK INC. | f2c338dc-5bab-49f4-a4ac-d8dea8afeea5 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | febuxostat FEBUXOSTAT |
| FEBUXOSTAT | FEBUXOSTAT | HEC Pharm USA Inc. | 4f1d0452-e041-cda6-e063-6394a90a2aef | 2026-03-10 | Boxed warning, Warnings, Adverse reactions | FEBUXOSTAT FEBUXOSTAT |
| Febuxostat | FEBUXOSTAT | Novadoz Pharmaceuticals LLC | d1969ea8-5178-42ee-97fc-feee8595e677 | 2026-02-20 | Boxed warning, Warnings, Adverse reactions | Febuxostat FEBUXOSTAT |
| ULORIC | FEBUXOSTAT | Takeda Pharmaceuticals America, Inc. | 54de10ef-fe5f-4930-b91d-6bbb04c664bd | 2025-12-24 | Boxed warning, Warnings, Adverse reactions | FEBUXOSTAT |
| Febuxostat | FEBUXOSTAT | Major Pharmaceuticals | 164feabd-f722-445b-b81a-d975b3db5f53 | 2025-11-14 | Boxed warning, Warnings, Adverse reactions | Febuxostat FEBUXOSTAT |
| Febuxostat | FEBUXOSTAT | NuCare Pharmaceuticals, Inc. | 2b5cf14a-6c5f-1eb2-e063-6294a90aaac8 | 2025-01-10 | Boxed warning, Warnings, Adverse reactions | Febuxostat FEBUXOSTAT |
| febuxostat | FEBUXOSTAT | NuCare Pharmaceuticals, Inc. | 2b5d205f-30e3-33e6-e063-6394a90aa683 | 2025-01-10 | Boxed warning, Warnings, Adverse reactions | febuxostat FEBUXOSTAT |
| febuxostat | FEBUXOSTAT | Zydus Lifesciences Limited | 0629ab39-196e-4198-902a-3c16277ba205 | 2024-08-16 | febuxostat FEBUXOSTAT | |
| Febuxostat | FEBUXOSTAT | NuCare Pharmaceuticals,Inc. | a745be75-4fa5-cbf9-e053-2995a90a3a81 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | Febuxostat FEBUXOSTAT |
| Febuxostat | FEBUXOSTAT | MAJOR PHARMACEUTICALS | 13a80059-46f7-4453-ab37-72744657a08a | 2024-06-04 | Boxed warning, Warnings, Adverse reactions | Febuxostat FEBUXOSTAT |
| Febuxostat | FEBUXOSTAT | Aurobindo Pharma Limited | 04f80eb2-8171-4e18-93e4-514440e84b75 | 2024-05-08 | Boxed warning, Warnings, Adverse reactions | Febuxostat FEBUXOSTAT |
| Febuxostat | FEBUXOSTAT | Golden State Medical Supply, Inc. | 97a8c7fc-0a66-2ddc-e053-2a95a90ad313 | 2024-04-10 | Boxed warning, Warnings, Adverse reactions | Febuxostat FEBUXOSTAT |
| Febuxostat | FEBUXOSTAT | American Health Packaging | 14f80ad5-37cc-4672-9caa-2dd2f469af0a | 2024-01-30 | Boxed warning, Warnings, Adverse reactions | Febuxostat FEBUXOSTAT |
| FEBUXOSTAT | FEBUXOSTAT | Lannett Company, Inc. | 73b07a94-c044-42dc-abe4-7d7c860c9638 | 2024-01-16 | Boxed warning, Warnings, Adverse reactions | FEBUXOSTAT FEBUXOSTAT |
| Febuxostat | FEBUXOSTAT | NorthStar RxLLC | ad40e0f6-850c-429a-87fc-f1eb2361e962 | 2023-11-21 | Boxed warning, Warnings, Adverse reactions | Febuxostat FEBUXOSTAT |
| Febuxostat | FEBUXOSTAT | Sun Pharmaceutical Industries, Inc. | 1f7541bd-bf32-422b-b99a-89193cf193ca | 2023-11-06 | Boxed warning, Warnings, Adverse reactions | Febuxostat FEBUXOSTAT |
| Febuxostat | FEBUXOSTAT TABLETS 40 MG | Macleods Pharmaceuticals Limited | 77875ed1-049e-421b-a8d5-569b4af4a1b5 | 2023-09-16 | Boxed warning, Warnings, Adverse reactions | Febuxostat |
| Febuxostat | FEBUXOSTAT | Tris Pharma Inc | d3b18653-9487-4a78-82c0-80ee024b8ef6 | 2023-06-20 | Boxed warning, Warnings, Adverse reactions | Febuxostat FEBUXOSTAT |
| FEBUXOSTAT | FEBUXOSTAT | Solco Healthcare US LLC | 4f5f8f2b-7200-4d76-9049-11dbc6cbd2ca | 2023-06-14 | Boxed warning, Warnings, Adverse reactions | FEBUXOSTAT FEBUXOSTAT |
| Febuxostat | FEBUXOSTAT | Hikma Pharmaceuticals USA Inc | 14f1555c-2565-42c7-b3f5-dd5f03fed67a | 2023-05-31 | Boxed warning, Warnings, Adverse reactions | Febuxostat FEBUXOSTAT |