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| 001 | TRICOR | FENOFIBRATE | TABLET;ORAL | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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003 | TRICOR | FENOFIBRATE | TABLET;ORAL | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| N021203-001 | TRICOR | FENOFIBRATE | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | |
| N021203-003 | TRICOR | FENOFIBRATE | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 |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| 2026-08 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 84e616aacf4f… | |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| 2026-08 | N021203-003 | TRICOR | 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | 84e616aacf4f… | |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| 2026-07 | N021203-001 | TRICOR | 54MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 2001-09-04 | caaa826d4ba7… | |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 | A-S Medication Solutions | c870ea48-5dde-4a6f-9ddb-56b494bb2b55 | 2026-09-09 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | REMEDYREPACK INC. | 882ee82a-3c56-4173-af42-68c3aadc8aa7 | 2026-09-04 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | A-S Medication Solutions | d0c7070e-b3bb-4b5b-8a62-4e3136b5accc | 2026-08-28 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | REMEDYREPACK INC. | b6b5d74d-d418-4ada-8ccd-592b0f57b2ff | 2026-08-04 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | REMEDYREPACK INC. | 3b6c5ebd-a8bc-4502-8b66-f4e58914815b | 2026-07-30 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Golden State Medical Supply, Inc. | 3e611f91-e351-9558-e063-6394a90ace17 | 2026-07-27 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Major Pharmaceuticals | d9be3ae3-6da9-47fd-bcfd-e561b9d585ca | 2026-07-16 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | American Health Packaging | 8b4488f4-bef6-408c-9fca-3e4aebceff9a | 2026-07-02 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Bostal LLC | 7eb328d0-4e6f-4b24-ae85-68c2b3657569 | 2026-06-30 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Sun Pharmaceutical Industries, Inc. | 2083f5d9-92f2-4c64-b996-fabbd6946ea0 | 2026-06-19 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Golden State Medical Supply, Inc. | 6dd2e25c-aded-4499-e053-2991aa0a9d60 | 2026-06-16 | Warnings, Adverse reactions | FENOFIBRATE |
| fenofibrate | FENOFIBRATE | Bryant Ranch Prepack | 42b1ad55-c449-4250-a666-bb36a6ff5b53 | 2026-06-11 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | A-S Medication Solutions | ce403472-6c0c-4854-bb82-ba6539e1ae07 | 2026-06-10 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | Amneal Pharmaceuticals LLC | 65f5dcad-5073-4347-9ec9-e7f350b134c4 | 2026-06-06 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | St. Mary's Medical Park Pharmacy | b92fb19a-d0df-426e-e053-2995a90ab379 | 2026-06-02 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | REMEDYREPACK INC. | fa9deae7-6cbf-4559-8130-b86b23b6d0ec | 2026-06-01 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Rhodes Pharmaceuticals LLC | 5e7b79ab-9df0-4bbf-b7a4-a44aec203555 | 2026-06-01 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | Bryant Ranch Prepack | b11f1c74-23da-4273-b504-0a2ca22c4b5a | 2026-05-29 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Westminster Pharmaceuticals, LLC | a97ebf51-4f68-4426-9958-5c59f91b1d47 | 2026-05-22 | Warnings, Adverse reactions | FENOFIBRATE |
| Lipofen | FENOFIBRATE | ANI Pharmaceuticals, Inc. | 78b789b9-854f-46b9-97f3-a48759a6ff89 | 2026-05-12 | 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 |