Application 019304
- Type
- NDA
- Sponsor
- ABBVIE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LIPIDIL | FENOFIBRATE | CAPSULE;ORAL | 100MG | No | No |
| 002 | TRICOR (MICRONIZED) | FENOFIBRATE | CAPSULE;ORAL | 67MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | TRICOR (MICRONIZED) | FENOFIBRATE | CAPSULE;ORAL | 134MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | TRICOR (MICRONIZED) | FENOFIBRATE | CAPSULE;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N019304-001 | LIPIDIL | FENOFIBRATE | 100MG | CAPSULE / ORAL | 1993-12-31 | ||
| N019304-002 | TRICOR (MICRONIZED) | FENOFIBRATE | 67MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1998-02-09 | |
| N019304-003 | TRICOR (MICRONIZED) | FENOFIBRATE | 134MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-30 | |
| N019304-004 | TRICOR (MICRONIZED) | FENOFIBRATE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-30 |
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 | N019304-001 | LIPIDIL | 100MG | CAPSULE / ORAL | 1993-12-31 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019304-002 | TRICOR (MICRONIZED) | 67MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1998-02-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019304-003 | TRICOR (MICRONIZED) | 134MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019304-004 | TRICOR (MICRONIZED) | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019304-001 | LIPIDIL | 100MG | CAPSULE / ORAL | 1993-12-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019304-002 | TRICOR (MICRONIZED) | 67MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1998-02-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019304-003 | TRICOR (MICRONIZED) | 134MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019304-004 | TRICOR (MICRONIZED) | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019304-001 | LIPIDIL | 100MG | CAPSULE / ORAL | 1993-12-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019304-002 | TRICOR (MICRONIZED) | 67MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1998-02-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019304-003 | TRICOR (MICRONIZED) | 134MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019304-004 | TRICOR (MICRONIZED) | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019304-001 | LIPIDIL | 100MG | CAPSULE / ORAL | 1993-12-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019304-002 | TRICOR (MICRONIZED) | 67MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1998-02-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019304-003 | TRICOR (MICRONIZED) | 134MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019304-004 | TRICOR (MICRONIZED) | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019304-001 | LIPIDIL | 100MG | CAPSULE / ORAL | 1993-12-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019304-002 | TRICOR (MICRONIZED) | 67MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1998-02-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019304-003 | TRICOR (MICRONIZED) | 134MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019304-004 | TRICOR (MICRONIZED) | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019304-001 | LIPIDIL | 100MG | CAPSULE / ORAL | 1993-12-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019304-002 | TRICOR (MICRONIZED) | 67MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1998-02-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019304-003 | TRICOR (MICRONIZED) | 134MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019304-004 | TRICOR (MICRONIZED) | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019304-001 | LIPIDIL | 100MG | CAPSULE / ORAL | 1993-12-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019304-002 | TRICOR (MICRONIZED) | 67MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1998-02-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019304-003 | TRICOR (MICRONIZED) | 134MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019304-004 | TRICOR (MICRONIZED) | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019304-001 | LIPIDIL | 100MG | CAPSULE / ORAL | 1993-12-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019304-002 | TRICOR (MICRONIZED) | 67MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1998-02-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019304-003 | TRICOR (MICRONIZED) | 134MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019304-004 | TRICOR (MICRONIZED) | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019304-001 | LIPIDIL | 100MG | CAPSULE / ORAL | 1993-12-31 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019304-002 | TRICOR (MICRONIZED) | 67MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1998-02-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019304-003 | TRICOR (MICRONIZED) | 134MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019304-004 | TRICOR (MICRONIZED) | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019304-001 | LIPIDIL | 100MG | CAPSULE / ORAL | 1993-12-31 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019304-002 | TRICOR (MICRONIZED) | 67MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1998-02-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019304-003 | TRICOR (MICRONIZED) | 134MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019304-004 | TRICOR (MICRONIZED) | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 1999-06-30 | 5bbf6a4d5a75… |
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 | AvPAK | e949c068-bc7d-3038-e053-2a95a90aee00 | 2026-01-08 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Northwind Health Company, LLC | 0865c177-b78a-318e-e063-6394a90a318a | 2026-01-01 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Northwind Health Company, LLC | f2f46239-951d-fc0e-e053-2995a90ae979 | 2026-01-01 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | Northwind Health Company, LLC | f7590970-c54d-24e9-e053-6294a90ac400 | 2026-01-01 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Northwind Health Company, LLC | 0178ea2e-2c79-b97b-e063-6394a90ac145 | 2026-01-01 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Northwind Health Company, LLC | f2b6e2a7-68d7-264d-e053-2a95a90aa9d1 | 2026-01-01 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | Northwind Health Company, LLC | 4b4447a1-8136-4258-b2c8-c5f9c1bcec92 | 2025-12-26 | Warnings, Adverse reactions | FENOFIBRATE |
| fenofibrate | FENOFIBRATE | Chartwell RX, LLC. | 2d0cfddc-ace3-4187-8d94-d760d23d20b6 | 2025-12-10 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | AvKARE | 44efa0d1-19d6-9696-e063-6394a90a068d | 2025-12-01 | Warnings, Adverse reactions | FENOFIBRATE |
| fenofibrate | FENOFIBRATE | Ajanta Pharma USA Inc. | eb400ea7-bbd8-440b-b8be-082121621408 | 2025-11-30 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | Solco Healthcare US, LLC | 085109a6-f006-44f0-a170-980d8899a365 | 2025-11-30 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Lupin Pharmaceuticals, Inc. | 4cb6617c-f787-470f-81d8-0aba46df937f | 2025-11-19 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Lupin Pharmaceuticals, Inc. | 45364845-c3b4-40a1-a677-82202ffaa5ad | 2025-11-19 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | AvPAK | d4e1d692-3c03-7406-ee06-7a6fb39ed3e7 | 2025-11-16 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Apotex Corp. | 68024459-987a-9cf4-f539-4959093bc9f0 | 2025-10-29 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Bryant Ranch Prepack | f04cfe2a-1c06-4a7f-8149-7736a96e8f73 | 2025-10-24 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | A-S Medication Solutions | db3ac584-2c8e-4f69-b24c-96ddcca2c23f | 2025-10-16 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | A-S Medication Solutions | d26e21bf-6c54-437d-81fe-07220e450561 | 2025-10-16 | Warnings, Adverse reactions | FENOFIBRATE |
| FENOFIBRATE | FENOFIBRATE | Creekwood Pharmaceuticals LLC | 65d8aefc-7ec2-4f62-9254-5f0070c58ac2 | 2025-10-09 | Warnings, Adverse reactions | FENOFIBRATE |
| Fenofibrate | FENOFIBRATE | Cipla USA Inc. | f8f09ab1-74db-4123-b85a-6337dc2582a0 | 2025-10-06 | Warnings, Adverse reactions | FENOFIBRATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.