Application 021203
- Type
- NDA
- Sponsor
- ABBVIE INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRICOR | FENOFIBRATE | TABLET;ORAL | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | TRICOR | FENOFIBRATE | TABLET;ORAL | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021203-001 | TRICOR | FENOFIBRATE | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | |
| N021203-003 | TRICOR | FENOFIBRATE | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 |
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| 2026-08 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021203-003 | TRICOR | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021203-003 | TRICOR | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021203-003 | TRICOR | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021203-003 | TRICOR | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021203-003 | TRICOR | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021203-003 | TRICOR | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021203-003 | TRICOR | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021203-003 | TRICOR | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021203-003 | TRICOR | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021203-003 | TRICOR | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021203-003 | TRICOR | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021203-003 | TRICOR | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021203-003 | TRICOR | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021203-003 | TRICOR | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021203-003 | TRICOR | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021203-003 | TRICOR | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021203-003 | TRICOR | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021203-001 | TRICOR | 54MG | TABLET / ORAL | RLD | 2001-09-04 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021203-003 | TRICOR | 160MG | TABLET / ORAL | RLD | 2001-09-04 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021203-001 | TRICOR | 54MG | TABLET / ORAL | RLD | 2001-09-04 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021203-003 | TRICOR | 160MG | TABLET / ORAL | RLD | 2001-09-04 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 2001-09-04 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021203-003 | TRICOR | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 2001-09-04 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| Fenofibrate | FENOFIBRATE | Chartwell RX, LLC | cc9d1672-5f82-45a1-b862-859703b3dc37 | 2024-07-09 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | NuCare Pharmaceuticals,Inc. | 968e7f57-1360-ba5a-e053-2995a90a206c | 2024-06-19 | Warnings, Adverse reactions | FENOFIBRATE |
| fenofibrate | FENOFIBRATE | NuCare Pharmaceuticals,Inc. | 8e9898d1-1fc0-b7c6-e053-2a95a90a65cd | 2024-06-18 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | A-S Medication Solutions | 17edfb43-b708-45cc-9b48-54a4d453adac | 2024-04-30 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | A-S Medication Solutions | 00c2f942-e839-46fc-948a-f8e2fa79ccd1 | 2024-04-29 | Warnings, Adverse reactions | FENOFIBRATE |
| Tricor | FENOFIBRATE | A-S Medication Solutions | 84b2af1b-365e-4723-ac5f-bc826ec47772 | 2024-04-29 | Warnings, Adverse reactions | Tricor FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | A-S Medication Solutions | dd98e467-ecb3-463c-81d8-8b4d89159ab0 | 2024-02-27 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Bryant Ranch Prepack | 67a0cee0-79be-472a-a2a3-3aee2410b58b | 2024-01-12 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | A-S Medication Solutions | 3f2b3a16-7735-487e-9a2c-e078a18df1bc | 2024-01-01 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | A-S Medication Solutions | f937a176-3d3e-4dc6-a7d4-c1a4749c7a7f | 2023-12-27 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Bryant Ranch Prepack | f3af845c-ce4e-4bf2-82e7-7753c9088645 | 2023-12-07 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Bryant Ranch Prepack | 42b1daf6-1f0e-4464-b160-7c10c492a570 | 2023-11-17 | Warnings, Adverse reactions | FENOFIBRATE |
| fenofibrate | FENOFIBRATE | A-S Medication Solutions | 9d284236-c788-4e9e-8573-4d119e45d3b9 | 2023-11-01 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | A-S Medication Solutions | 734f72a2-96f7-4480-9a87-c1ffd94b5f0b | 2023-07-26 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | A-S Medication Solutions | 06870192-c92a-40c7-a619-efda0c006301 | 2023-04-19 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | Bryant Ranch Prepack | d34f9fa3-39ae-4b8e-8f29-0d5c655c50b5 | 2023-03-31 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Alembic Pharmaceuticals Limited | 65ca643c-3b31-4e53-bc06-0e11418baf7d | 2023-01-30 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Alembic Pharmaceuticals Limited | 39e61e9d-dda8-4989-a3dd-79545a5c9157 | 2023-01-27 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | Alembic Pharmaceuticals Limited | ddafb483-bae5-49bf-845d-67c29e6dc12d | 2023-01-27 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Cipla USA Inc., | 07d47c02-ab29-4ba9-aea0-96ffbd70c0ef | 2023-01-20 | Warnings, Adverse reactions | FENOFIBRATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 58189 | SUPPL | 2019-06-07 |
| 58138 | SUPPL | 2019-03-29 |
| 56494 | SUPPL | 2018-11-16 |
| 56387 | SUPPL | 2018-11-08 |
| 54294 | SUPPL | 2018-05-22 |
| 54274 | SUPPL | 2018-05-21 |
| 47008 | SUPPL | 2017-01-30 |
| 46975 | SUPPL | 2017-01-25 |
| 14629 | SUPPL | 2014-12-10 |
| 27053 | SUPPL | 2014-12-09 |
| 42019 | ORIG | 2005-04-15 |
| 36337 | ORIG | 2001-09-05 |
| 27052 | ORIG | 2001-09-05 |