Application 216811
- Type
- ANDA
- Sponsor
- ASCENT PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ICOSAPENT ETHYL | ICOSAPENT ETHYL | CAPSULE;ORAL | 500MG | No | No |
| 002 | ICOSAPENT ETHYL | ICOSAPENT ETHYL | CAPSULE;ORAL | 1GM | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216811-001 | ICOSAPENT ETHYL | ICOSAPENT ETHYL | 500MG | CAPSULE / ORAL | AB | 2023-12-07 | |
| A216811-002 | ICOSAPENT ETHYL | ICOSAPENT ETHYL | 1GM | CAPSULE / ORAL | AB | 2024-02-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A216811-001 | AB |
| A216811-002 | AB |
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 | A216811-001 | ICOSAPENT ETHYL | 500MG | CAPSULE / ORAL | AB | 2023-12-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216811-002 | ICOSAPENT ETHYL | 1GM | CAPSULE / ORAL | AB | 2024-02-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216811-001 | ICOSAPENT ETHYL | 500MG | CAPSULE / ORAL | AB | 2023-12-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216811-002 | ICOSAPENT ETHYL | 1GM | CAPSULE / ORAL | AB | 2024-02-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216811-001 | ICOSAPENT ETHYL | 500MG | CAPSULE / ORAL | AB | 2023-12-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216811-002 | ICOSAPENT ETHYL | 1GM | CAPSULE / ORAL | AB | 2024-02-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216811-001 | ICOSAPENT ETHYL | 500MG | CAPSULE / ORAL | AB | 2023-12-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216811-002 | ICOSAPENT ETHYL | 1GM | CAPSULE / ORAL | AB | 2024-02-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216811-001 | ICOSAPENT ETHYL | 500MG | CAPSULE / ORAL | AB | 2023-12-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216811-002 | ICOSAPENT ETHYL | 1GM | CAPSULE / ORAL | AB | 2024-02-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216811-001 | ICOSAPENT ETHYL | 500MG | CAPSULE / ORAL | AB | 2023-12-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216811-002 | ICOSAPENT ETHYL | 1GM | CAPSULE / ORAL | AB | 2024-02-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216811-001 | ICOSAPENT ETHYL | 500MG | CAPSULE / ORAL | AB | 2023-12-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216811-002 | ICOSAPENT ETHYL | 1GM | CAPSULE / ORAL | AB | 2024-02-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216811-001 | ICOSAPENT ETHYL | 500MG | CAPSULE / ORAL | AB | 2023-12-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216811-002 | ICOSAPENT ETHYL | 1GM | CAPSULE / ORAL | AB | 2024-02-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216811-001 | ICOSAPENT ETHYL | 500MG | CAPSULE / ORAL | AB | 2023-12-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216811-002 | ICOSAPENT ETHYL | 1GM | CAPSULE / ORAL | AB | 2024-02-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216811-001 | ICOSAPENT ETHYL | 500MG | CAPSULE / ORAL | AB | 2023-12-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216811-002 | ICOSAPENT ETHYL | 1GM | CAPSULE / ORAL | AB | 2024-02-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216811-001 | ICOSAPENT ETHYL | 500MG | CAPSULE / ORAL | AB | 2023-12-07 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216811-002 | ICOSAPENT ETHYL | 1GM | CAPSULE / ORAL | AB | 2024-02-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216811-001 | ICOSAPENT ETHYL | 500MG | CAPSULE / ORAL | AB | 2023-12-07 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216811-002 | ICOSAPENT ETHYL | 1GM | CAPSULE / ORAL | AB | 2024-02-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216811-001 | ICOSAPENT ETHYL | 500MG | CAPSULE / ORAL | AB | 2023-12-07 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216811-002 | ICOSAPENT ETHYL | 1GM | CAPSULE / ORAL | AB | 2024-02-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A216811-001 | ICOSAPENT ETHYL | 500MG | CAPSULE / ORAL | AB | 2023-12-07 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A216811-002 | ICOSAPENT ETHYL | 1GM | CAPSULE / ORAL | AB | 2024-02-16 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216811-001 | ICOSAPENT ETHYL | 500MG | CAPSULE / ORAL | AB | 2023-12-07 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216811-002 | ICOSAPENT ETHYL | 1GM | CAPSULE / ORAL | AB | 2024-02-16 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A216811-001 | ICOSAPENT ETHYL | 500MG | CAPSULE / ORAL | AB | 2023-12-07 | 1c564ffb4f44… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216811-001 | ICOSAPENT ETHYL | 500MG | CAPSULE / ORAL | AB | 2023-12-07 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216811-002 | ICOSAPENT ETHYL | 1GM | CAPSULE / ORAL | AB | 2024-02-16 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A216811-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216811-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216811-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216811-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A216811-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216811-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216811-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216811-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216811-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216811-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216811-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216811-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216811-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216811-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216811-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216811-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216811-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216811-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A216811-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216811-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216811-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216811-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216811-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216811-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216811-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216811-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A216811-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A216811-002 | AB | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216811-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216811-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A216811-001 | AB | 1 | 1c564ffb4f44… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216811-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216811-002 | AB | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| ICOSAPENT ETHYL | ICOSAPENT ETHYL | Camber Pharmaceuticals, Inc. | 3e3498ab-f35e-4597-8556-89bf9fdd1406 | 2026-04-30 | Warnings, Adverse reactions | 216811 ANDA216811 |
| ICOSAPENT ETHYL | ICOSAPENT ETHYL | XLCare Pharmaceuticals, Inc. | 019cc0ac-0c2f-426d-996a-6d932f954443 | 2026-04-30 | Warnings, Adverse reactions | 216811 ANDA216811 |
| ICOSAPENT ETHYL | ICOSAPENT ETHYL | Bryant Ranch Prepack | b4a1ca8a-2d22-4c54-9193-eab4e75ba7db | 2026-02-04 | Warnings, Adverse reactions | 216811 ANDA216811 |
| ICOSAPENT ETHYL | ICOSAPENT ETHYL | Northstar Rx LLC | b5b0b1ae-29ab-43a5-9e6d-24374d961399 | 2025-03-05 | Warnings, Adverse reactions | 216811 ANDA216811 |