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| 001 | TRICOR | FENOFIBRATE | TABLET;ORAL | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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003 | TRICOR | FENOFIBRATE | TABLET;ORAL | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| N021203-001 | TRICOR | FENOFIBRATE | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | |
| N021203-003 | TRICOR | FENOFIBRATE | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 |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| 2026-08 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 84e616aacf4f… | |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| 2026-08 | N021203-003 | TRICOR | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 84e616aacf4f… | |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| 2026-07 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | caaa826d4ba7… | |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 | Alembic Pharmaceuticals Limited | 954753e7-c8d4-487c-b2ad-f90dfb758a92 | 2023-01-16 | Warnings, Adverse reactions | FENOFIBRATE |
| fenofibrate | FENOFIBRATE | Laurus Labs Limited | 0da6d56e-1ed6-437d-b88d-16b014d1889a | 2022-12-28 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | Laurus Labs Limited | 8e58c13a-8088-4fed-86cc-52530de5aa45 | 2022-12-28 | Warnings, Adverse reactions | FENOFIBRATE |
| fenofibrate | FENOFIBRATE | Proficient Rx LP | b9a6866c-9dbe-4419-bcad-52ec0127821f | 2022-11-01 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | Proficient Rx LP | 26f8f793-fb7a-4327-9441-d8737fe1ff11 | 2022-06-01 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Alembic Pharmaceuticals Inc. | d5c046b5-c3fd-4ef3-8245-c93796d4d880 | 2022-05-12 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Proficient Rx LP | 41f0f514-1fa9-47a0-a085-a31354842f96 | 2022-03-01 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Alembic Pharmaceuticals Inc. | 4387adac-eea0-40c5-8111-1b70e0d98d7e | 2021-11-16 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Alembic Pharmaceuticals Inc. | 2985c70d-e85d-483e-8d36-7a4b8454b038 | 2021-11-08 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Aurobindo Pharma Limited | 05957860-eab3-4172-9877-455540d0c922 | 2021-09-08 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | Amneal Pharmaceuticals of New York LLC | fa08cf6a-d306-4979-9b23-ac7febf4fd12 | 2021-04-01 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Amneal Pharmaceuticals NY LLC | 7e79d495-5d59-485e-b3c2-7c31ba044948 | 2021-03-30 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Dr. Reddy's Laboratories Inc. | 9e69d844-5ded-46b6-8321-c420e8b37a63 | 2021-03-24 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Alembic Pharmaceuticals Inc. | 1e56492f-e2b1-4a07-b697-b59b3a0ac05e | 2021-02-24 | Warnings, Adverse reactions | FENOFIBRATE |
| fenofibrate | FENOFIBRATE | NCS HealthCare of KY, Inc dba Vangard Labs | fafbc0be-f0ba-4dcd-8aa5-89527bae5e84 | 2019-03-08 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Dr. Reddy's Laboratories Limited | 16ea8ce4-8c1c-4111-509e-86aa688d89a0 | 2018-12-28 | 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 |