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| 001 | TRICOR | FENOFIBRATE | TABLET;ORAL | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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003 | TRICOR | FENOFIBRATE | TABLET;ORAL | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| N021203-001 | TRICOR | FENOFIBRATE | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | |
| N021203-003 | TRICOR | FENOFIBRATE | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 |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| 2026-08 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 84e616aacf4f… | |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| 2026-08 | N021203-003 | TRICOR | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 84e616aacf4f… | |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| 2026-07 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | caaa826d4ba7… | |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 | ANI Pharmaceuticals, Inc. | 3a69e15a-eda6-4a6e-8934-6881e4370521 | 2026-05-12 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | A-S Medication Solutions | df9f67d6-3cd9-4f44-8020-2d6ef53c30b5 | 2026-05-08 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Bostal LLC | a5bc232c-ff27-f8b6-e053-2995a90ad399 | 2026-04-29 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Preferred Pharmaceuticals, Inc. | c810b16b-32e2-4d0c-aa28-bf1f62110757 | 2026-04-15 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | Preferred Pharmaceuticals Inc. | e573b3f1-5a4c-4a19-9f0f-ee797b379a08 | 2026-04-15 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Safecor Health, LLC | 9cc2038d-750e-42dc-b818-c5642cf6a5ad | 2026-03-20 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | Bryant Ranch Prepack | 3389b846-8926-3ad5-e063-6294a90aee39 | 2026-03-16 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | A-S Medication Solutions | f443dd79-46da-4b02-8188-7417d39cf975 | 2026-03-10 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Macleods Pharmaceuticals Limited | a504c42a-b629-4a21-a716-084962266b48 | 2026-03-09 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | PD-Rx Pharmaceuticals, Inc. | 2f5cee5c-ec55-4e9b-9d54-e7f2f052130e | 2026-02-26 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | NuCare Pharmaceuticals,Inc. | bdc2211e-6d65-1500-e053-2a95a90ab145 | 2026-02-20 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Bryant Ranch Prepack | bbeae8e4-e06a-4c19-a1b9-f6143306dab9 | 2026-02-16 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | REMEDYREPACK INC. | b79efcf4-6016-4a1f-b83f-be00baa25c21 | 2026-02-13 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Bostal LLC | edace25a-3296-9ca7-dcb8-d0698f65840d | 2026-02-04 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | A-S Medication Solutions | d9c60b43-dc61-4976-b31f-09c8f8a33138 | 2026-02-04 | Warnings, Adverse reactions | FENOFIBRATE |
| fenofibrate | FENOFIBRATE | Glenmark Pharmaceuticals Inc., USA | e7204052-02cf-4b38-835b-d8754c74b2cd | 2026-01-31 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | AvKARE | f669f231-98b9-5014-e053-2a95a90a4e4c | 2026-01-14 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | AvKARE | 0e240290-f11b-8cc4-e063-6294a90a74f0 | 2026-01-13 | Warnings, Adverse reactions | FENOFIBRATE |
| fenofibrate | FENOFIBRATE | A-S Medication Solutions | 58f0d475-24dc-4f93-aa40-3882b724b70f | 2026-01-09 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | Major Pharmaceuticals | bbffd586-f63a-4a84-bdfb-3e4a1df6449e | 2026-01-09 | 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 |