Application 021695
- Type
- NDA
- Sponsor
- LUPIN ATLANTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ANTARA (MICRONIZED) | FENOFIBRATE | CAPSULE;ORAL | 43MG | Yes | No |
| 002 | ANTARA (MICRONIZED) | FENOFIBRATE | CAPSULE;ORAL | 87MG | No | No |
| 003 | ANTARA (MICRONIZED) | FENOFIBRATE | CAPSULE;ORAL | 130MG | Yes | Yes |
| 004 | ANTARA (MICRONIZED) | FENOFIBRATE | CAPSULE;ORAL | 30MG | Yes | No |
| 005 | ANTARA (MICRONIZED) | FENOFIBRATE | CAPSULE;ORAL | 90MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021695-001 | ANTARA (MICRONIZED) | FENOFIBRATE | 43MG | CAPSULE / ORAL | AB | RLD | 2004-11-30 |
| N021695-002 | ANTARA (MICRONIZED) | FENOFIBRATE | 87MG | CAPSULE / ORAL | 2004-11-30 | ||
| N021695-003 | ANTARA (MICRONIZED) | FENOFIBRATE | 130MG | CAPSULE / ORAL | AB | RLD, RS | 2004-11-30 |
| N021695-004 | ANTARA (MICRONIZED) | FENOFIBRATE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | |
| N021695-005 | ANTARA (MICRONIZED) | FENOFIBRATE | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021695-001 | AB |
| N021695-003 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N021695-005 | 9314447 | 2033-05-31 | U-1447 | Drug product | 2016-05-02 |
| N021695-005 | 9314447 | 2033-05-31 | U-1448 | Drug product | 2016-05-02 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021695-001 | ANTARA (MICRONIZED) | 43MG | CAPSULE / ORAL | AB | RLD | 2004-11-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021695-002 | ANTARA (MICRONIZED) | 87MG | CAPSULE / ORAL | 2004-11-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N021695-003 | ANTARA (MICRONIZED) | 130MG | CAPSULE / ORAL | AB | RLD, RS | 2004-11-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021695-004 | ANTARA (MICRONIZED) | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021695-005 | ANTARA (MICRONIZED) | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021695-001 | ANTARA (MICRONIZED) | 43MG | CAPSULE / ORAL | AB | RLD | 2004-11-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021695-002 | ANTARA (MICRONIZED) | 87MG | CAPSULE / ORAL | 2004-11-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021695-003 | ANTARA (MICRONIZED) | 130MG | CAPSULE / ORAL | AB | RLD, RS | 2004-11-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021695-004 | ANTARA (MICRONIZED) | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021695-005 | ANTARA (MICRONIZED) | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021695-001 | ANTARA (MICRONIZED) | 43MG | CAPSULE / ORAL | AB | RLD | 2004-11-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021695-002 | ANTARA (MICRONIZED) | 87MG | CAPSULE / ORAL | 2004-11-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021695-003 | ANTARA (MICRONIZED) | 130MG | CAPSULE / ORAL | AB | RLD, RS | 2004-11-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021695-004 | ANTARA (MICRONIZED) | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021695-005 | ANTARA (MICRONIZED) | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021695-001 | ANTARA (MICRONIZED) | 43MG | CAPSULE / ORAL | AB | RLD | 2004-11-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021695-002 | ANTARA (MICRONIZED) | 87MG | CAPSULE / ORAL | 2004-11-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021695-003 | ANTARA (MICRONIZED) | 130MG | CAPSULE / ORAL | AB | RLD, RS | 2004-11-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021695-004 | ANTARA (MICRONIZED) | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021695-005 | ANTARA (MICRONIZED) | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021695-001 | ANTARA (MICRONIZED) | 43MG | CAPSULE / ORAL | AB | RLD | 2004-11-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021695-002 | ANTARA (MICRONIZED) | 87MG | CAPSULE / ORAL | 2004-11-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021695-003 | ANTARA (MICRONIZED) | 130MG | CAPSULE / ORAL | AB | RLD, RS | 2004-11-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021695-004 | ANTARA (MICRONIZED) | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021695-005 | ANTARA (MICRONIZED) | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021695-001 | ANTARA (MICRONIZED) | 43MG | CAPSULE / ORAL | AB | RLD | 2004-11-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021695-002 | ANTARA (MICRONIZED) | 87MG | CAPSULE / ORAL | 2004-11-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021695-003 | ANTARA (MICRONIZED) | 130MG | CAPSULE / ORAL | AB | RLD, RS | 2004-11-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021695-004 | ANTARA (MICRONIZED) | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021695-005 | ANTARA (MICRONIZED) | 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021695-001 | ANTARA (MICRONIZED) | 43MG | CAPSULE / ORAL | AB | RLD | 2004-11-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021695-002 | ANTARA (MICRONIZED) | 87MG | CAPSULE / ORAL | 2004-11-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021695-003 | ANTARA (MICRONIZED) | 130MG | CAPSULE / ORAL | AB | RLD, RS | 2004-11-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021695-004 | ANTARA (MICRONIZED) | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021695-005 | ANTARA (MICRONIZED) | 90MG | CAPSULE / ORAL | RLD | 2013-10-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021695-001 | ANTARA (MICRONIZED) | 43MG | CAPSULE / ORAL | AB | RLD | 2004-11-30 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021695-002 | ANTARA (MICRONIZED) | 87MG | CAPSULE / ORAL | 2004-11-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021695-003 | ANTARA (MICRONIZED) | 130MG | CAPSULE / ORAL | AB | RLD, RS | 2004-11-30 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021695-004 | ANTARA (MICRONIZED) | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2013-10-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021695-005 | ANTARA (MICRONIZED) | 90MG | CAPSULE / ORAL | RLD | 2013-10-18 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021695-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021695-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021695-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021695-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021695-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021695-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021695-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021695-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021695-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021695-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021695-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021695-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021695-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021695-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021695-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021695-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021695-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021695-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021695-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021695-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021695-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021695-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021695-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021695-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021695-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021695-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021695-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021695-003 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021695-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021695-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021695-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021695-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021695-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N021695-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021695-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021695-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021695-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N021695-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021695-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N021695-003 | AB | 1 | 782e0a99824c… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021695-005 | 9314447 | 2033-05-31 | U-1447 | Drug product | 2016-05-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021695-005 | 9314447 | 2033-05-31 | U-1448 | Drug product | 2016-05-02 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021695-004 | 8026281 | 2025-04-22 | U-1448 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021695-004 | 8026281 | 2025-04-22 | U-1447 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021695-005 | 8026281 | 2025-04-22 | U-1447 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021695-005 | 8026281 | 2025-04-22 | U-1448 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021695-005 | 9314447 | 2033-05-31 | U-1447 | Drug product | 2016-05-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021695-005 | 9314447 | 2033-05-31 | U-1448 | Drug product | 2016-05-02 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021695-004 | 8026281 | 2025-04-22 | U-1448 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021695-004 | 8026281 | 2025-04-22 | U-1447 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021695-005 | 8026281 | 2025-04-22 | U-1447 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021695-005 | 8026281 | 2025-04-22 | U-1448 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N021695-005 | 9314447 | 2033-05-31 | U-1447 | Drug product | 2016-05-02 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021695-005 | 9314447 | 2033-05-31 | U-1448 | Drug product | 2016-05-02 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021695-004 | 8026281 | 2025-04-22 | U-1448 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021695-004 | 8026281 | 2025-04-22 | U-1447 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021695-005 | 8026281 | 2025-04-22 | U-1447 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021695-005 | 8026281 | 2025-04-22 | U-1448 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021695-005 | 9314447 | 2033-05-31 | U-1447 | Drug product | 2016-05-02 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021695-005 | 9314447 | 2033-05-31 | U-1448 | Drug product | 2016-05-02 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021695-004 | 8026281 | 2025-04-22 | U-1448 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021695-004 | 8026281 | 2025-04-22 | U-1447 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021695-005 | 8026281 | 2025-04-22 | U-1447 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021695-005 | 8026281 | 2025-04-22 | U-1448 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021695-005 | 9314447 | 2033-05-31 | U-1447 | Drug product | 2016-05-02 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021695-005 | 9314447 | 2033-05-31 | U-1448 | Drug product | 2016-05-02 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021695-004 | 8026281 | 2025-04-22 | U-1448 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021695-004 | 8026281 | 2025-04-22 | U-1447 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021695-005 | 8026281 | 2025-04-22 | U-1447 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021695-005 | 8026281 | 2025-04-22 | U-1448 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021695-005 | 9314447 | 2033-05-31 | U-1447 | Drug product | 2016-05-02 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021695-005 | 9314447 | 2033-05-31 | U-1448 | Drug product | 2016-05-02 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021695-004 | 8026281 | 2025-04-22 | U-1448 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021695-004 | 8026281 | 2025-04-22 | U-1447 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021695-005 | 8026281 | 2025-04-22 | U-1447 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021695-005 | 8026281 | 2025-04-22 | U-1448 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021695-005 | 9314447 | 2033-05-31 | U-1447 | Drug product | 2016-05-02 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021695-005 | 9314447 | 2033-05-31 | U-1448 | Drug product | 2016-05-02 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021695-004 | 8026281 | 2025-04-22 | U-1448 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021695-004 | 8026281 | 2025-04-22 | U-1447 | 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 |
|---|---|---|---|---|---|---|
| ANTARA | FENOFIBRATE | Lupin Pharmaceuticals, Inc. | 24790a18-0291-4b88-a724-acac43b616ce | 2025-10-01 | Warnings, Adverse reactions | 021695 NDA021695 27437-110 27437-109 |
| Fenofibrate | FENOFIBRATE | Lupin Pharmaceuticals, Inc. | 37b25526-0bd0-4459-a4be-f3a6893506f9 | 2025-06-02 | Warnings, Adverse reactions | 021695 NDA021695 68180-131 68180-130 |
| Antara | FENOFIBRATE | Lupin Pharmaceuticals, Inc. | 12ebf783-64df-4ffa-9e84-f8fdf4d245d4 | 2024-08-20 | Warnings, Adverse reactions | 021695 NDA021695 27437-108 27437-107 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 27437-107 | Antara | fenofibrate | Lupin Pharmaceuticals, Inc. | NDA | Current |
| 27437-107 | Antara | fenofibrate | Lupin Pharmaceuticals, Inc. | NDA | Current |
| 27437-107 | Antara | fenofibrate | Lupin Pharmaceuticals, Inc. | NDA | Current |
| 27437-108 | Antara | fenofibrate | Lupin Pharmaceuticals, Inc. | NDA | Current |
| 27437-108 | Antara | fenofibrate | Lupin Pharmaceuticals, Inc. | NDA | Current |
| 27437-108 | Antara | fenofibrate | Lupin Pharmaceuticals, Inc. | NDA | Current |
| 27437-109 | ANTARA | FENOFIBRATE | Lupin Pharmaceuticals, Inc. | NDA | Current |
| 27437-109 | ANTARA | FENOFIBRATE | Lupin Pharmaceuticals, Inc. | NDA | Current |
| 27437-109 | ANTARA | FENOFIBRATE | Lupin Pharmaceuticals, Inc. | NDA | Current |
| 27437-109 | ANTARA | FENOFIBRATE | Lupin Pharmaceuticals, Inc. | NDA | Current |
| 27437-110 | ANTARA | FENOFIBRATE | Lupin Pharmaceuticals, Inc. | NDA | Current |
| 27437-110 | ANTARA | FENOFIBRATE | Lupin Pharmaceuticals, Inc. | NDA | Current |
| 27437-110 | ANTARA | FENOFIBRATE | Lupin Pharmaceuticals, Inc. | NDA | Current |
| 27437-110 | ANTARA | FENOFIBRATE | Lupin Pharmaceuticals, Inc. | NDA | Current |
| 68180-130 | Fenofibrate | fenofibrate | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 68180-130 | Fenofibrate | fenofibrate | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 68180-130 | Fenofibrate | fenofibrate | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 68180-131 | Fenofibrate | fenofibrate | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 68180-131 | Fenofibrate | fenofibrate | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 68180-131 | Fenofibrate | fenofibrate | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 68180-745 | FENOFIBRATE | FENOFIBRATE | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 68180-745 | FENOFIBRATE | FENOFIBRATE | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 68180-745 | FENOFIBRATE | FENOFIBRATE | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 68180-745 | FENOFIBRATE | FENOFIBRATE | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 68180-746 | FENOFIBRATE | FENOFIBRATE | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 68180-746 | FENOFIBRATE | FENOFIBRATE | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 68180-746 | FENOFIBRATE | FENOFIBRATE | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 68180-746 | FENOFIBRATE | FENOFIBRATE | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83640 | SUPPL | 2025-10-03 |
| 83632 | SUPPL | 2025-10-02 |
| 79274 | SUPPL | 2024-08-02 |
| 79260 | SUPPL | 2024-07-31 |
| 67719 | SUPPL | 2021-06-07 |
| 67704 | SUPPL | 2021-06-04 |
| 58762 | SUPPL | 2019-05-16 |
| 58747 | SUPPL | 2019-05-16 |
| 57819 | SUPPL | 2019-02-27 |
| 57531 | SUPPL | 2019-02-13 |
| 56458 | SUPPL | 2018-11-15 |
| 56402 | SUPPL | 2018-11-09 |
| 54332 | SUPPL | 2018-05-24 |
| 54305 | SUPPL | 2018-05-22 |
| 49757 | SUPPL | 2017-09-15 |
| 49719 | SUPPL | 2017-09-12 |
| 16007 | SUPPL | 2015-09-04 |
| 28396 | SUPPL | 2013-10-22 |
| 16005 | SUPPL | 2013-10-22 |
| 6004 | SUPPL | 2012-12-26 |
| 16006 | SUPPL | 2012-12-21 |
| 37472 | SUPPL | 2012-03-06 |
| 28395 | SUPPL | 2012-03-05 |
| 16004 | SUPPL | 2008-06-19 |
| 28394 | SUPPL | 2008-06-06 |
| 6003 | SUPPL | 2007-01-23 |
| 21781 | ORIG | 2006-06-08 |
| 28393 | ORIG | 2004-12-06 |
| 16003 | ORIG | 2004-12-03 |