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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211837-001 | FEBUXOSTAT | 40MG | TABLET / ORAL | 2023-12-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A211837-002 | FEBUXOSTAT | 80MG | TABLET / ORAL | 2023-12-19 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211837-001 | FEBUXOSTAT | 40MG | TABLET / ORAL | 2023-12-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A211837-002 | FEBUXOSTAT | 80MG | TABLET / ORAL | 2023-12-19 | caaa826d4ba7… | ||
| 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 | Alembic Pharmaceuticals Inc. | 9a87099f-d82d-42c7-872a-b87d3917e960 | 2023-04-27 | Boxed warning, Warnings, Adverse reactions | Febuxostat FEBUXOSTAT |
| Febuxostat | FEBUXOSTAT | Alembic Pharmaceuticals Limited | 41a95424-046e-413b-a121-cd7335e67135 | 2023-01-19 | Boxed warning, Warnings, Adverse reactions | Febuxostat FEBUXOSTAT |
| Febuxostat | FEBUXOSTAT | Ascend Laboratories, LLC | 154ad94e-b775-4a10-ab0f-2874a0782db9 | 2022-09-06 | Boxed warning, Warnings, Adverse reactions | Febuxostat FEBUXOSTAT |
| Febuxostat | FEBUXOSTAT | Aphena Pharma Solutions - Tennessee, LLC | bc986925-fd24-4865-997c-ede55c2faffc | 2020-08-04 | Boxed warning, Warnings, Adverse reactions | Febuxostat FEBUXOSTAT |
| Febuxostat | FEBUXOSTAT | Aphena Pharma Solutions - Tennessee, LLC | bf4d29c8-4731-42bc-887a-d8302add9ca9 | 2020-04-22 | Boxed warning, Warnings, Adverse reactions | Febuxostat FEBUXOSTAT |
| Febuxostat | FEBUXOSTAT | DR REDDY'S LABORATORIES LIMITED | ccf2c4b1-e9a3-c7b7-ac42-79e1988fc211 | 2019-09-18 | Boxed warning, Warnings, Adverse reactions | Febuxostat FEBUXOSTAT |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.