Application 021654
- Type
- NDA
- Sponsor
- SMITHKLINE BEECHAM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LOVAZA | OMEGA-3-ACID ETHYL ESTERS | CAPSULE;ORAL | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021654-001 | LOVAZA | OMEGA-3-ACID ETHYL ESTERS | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021654-001 | 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 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021654-001 | LOVAZA | 1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS | CAPSULE / ORAL | AB | RLD, RS | 2004-11-10 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021654-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021654-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021654-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021654-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021654-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021654-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021654-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021654-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021654-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021654-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021654-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021654-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021654-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021654-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021654-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021654-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021654-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021654-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021654-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021654-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021654-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021654-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021654-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021654-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021654-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021654-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021654-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021654-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N021654-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N021654-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021654-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021654-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021654-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021654-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N021654-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N021654-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021654-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N021654-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N021654-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021654-001 | AB | 1 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| omega-3-acid ethyl esters | OMEGA-3-ACID ETHYL ESTERS | Strides Pharma Science Limited | 9499c40e-6665-4fbf-914d-1a9931b93562 | 2026-05-26 | Warnings, Adverse reactions | OMEGA-3-ACID ETHYL ESTERS |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | Major Pharmaceuticals | e40d55f2-db9f-4a48-8639-9aa7491e4de5 | 2026-05-21 | Warnings, Adverse reactions | OMEGA-3-ACID ETHYL ESTERS |
| Omega-3-acid ethyl esters | OMEGA-3-ACID ETHYL ESTERS | Camber Pharmaceuticals, Inc. | 0d842966-26bc-4521-b401-635a83618012 | 2026-04-30 | Warnings, Adverse reactions | OMEGA-3-ACID ETHYL ESTERS |
| Omega-3-acid ethyl esters | OMEGA-3-ACID ETHYL ESTERS | XLCare Pharmaceuticals, Inc. | 18947318-31b4-42fb-83be-8f1bfe732e95 | 2026-04-30 | Warnings, Adverse reactions | OMEGA-3-ACID ETHYL ESTERS |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | REMEDYREPACK INC. | c6b35b2d-5a65-4fc4-8a2c-af7b3aea3eee | 2026-04-27 | Warnings, Adverse reactions | OMEGA-3-ACID ETHYL ESTERS |
| Omega-3-Acid Ethyl Esters | OMEGA-3-ACID ETHYL ESTERS | Golden State Medical Supply, Inc. | 11d744aa-cc06-1206-e063-6294a90a49c9 | 2026-04-06 | Warnings, Adverse reactions | OMEGA-3-ACID ETHYL ESTERS |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | Lifestar Pharma LLC | 769ad170-5d70-4a54-995a-fef95ef503eb | 2026-02-13 | Warnings, Adverse reactions | OMEGA-3-ACID ETHYL ESTERS |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | A-S Medication Solutions | 6fea8860-3c63-435f-a5b0-4281364ebd09 | 2026-01-20 | Warnings, Adverse reactions | OMEGA-3-ACID ETHYL ESTERS |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | A-S Medication Solutions | 4eef8b47-8185-4d93-9b2a-1200b953a6e3 | 2026-01-20 | Warnings, Adverse reactions | OMEGA-3-ACID ETHYL ESTERS |
| omega-3-acid ethyl esters | OMEGA-3-ACID ETHYL ESTERS | Chartwell RX, LLC | 331d5d9d-58d8-4b4f-8114-b28efa7276d7 | 2025-12-22 | Warnings, Adverse reactions | OMEGA-3-ACID ETHYL ESTERS |
| omega-3-acid ethyl esters | OMEGA-3-ACID ETHYL ESTERS | American Health Packaging | 294ee73f-849c-4c3d-a415-d66138c91f53 | 2025-04-29 | Warnings, Adverse reactions | OMEGA-3-ACID ETHYL ESTERS |
| Omega-3-Acid Ethyl Esters | OMEGA-3-ACID ETHYL ESTERS | KD Pharma USA, Inc. | d1fd2a28-befb-4a09-b516-0c01bc4c8c6c | 2025-02-10 | Warnings, Adverse reactions | OMEGA-3-ACID ETHYL ESTERS |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | KD Pharma USA, Inc. | 5cf3091e-4a88-4799-a88a-d53a5bc1de57 | 2025-02-10 | Warnings, Adverse reactions | OMEGA-3-ACID ETHYL ESTERS |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 52d4fc86-227a-4a74-9f42-50fd184714d8 | 2025-01-08 | Warnings, Adverse reactions | OMEGA-3-ACID ETHYL ESTERS |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | EPIC PHARMA, LLC | 787f9929-ef31-42a7-a305-8ba343e39672 | 2025-01-07 | Warnings, Adverse reactions | OMEGA-3-ACID ETHYL ESTERS |
| Omega-3-acid ethyl esters | OMEGA-3-ACID ETHYL ESTERS | Bryant Ranch Prepack | 7d75287f-6f09-43b0-9b38-150685236d47 | 2024-12-27 | Warnings, Adverse reactions | OMEGA-3-ACID ETHYL ESTERS |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | NCS HealthCare of KY, LLC dba Vangard Labs | c293de7f-b4b6-461b-a0eb-470e5b84618d | 2024-10-18 | Warnings, Adverse reactions | OMEGA-3-ACID ETHYL ESTERS |
| OMEGA-3-ACID ETHYL ESTERS | OMEGA-3-ACID ETHYL ESTERS | Bryant Ranch Prepack | c8dc6c4a-ed19-4727-ba5a-35075f1ddddf | 2024-08-08 | Warnings, Adverse reactions | OMEGA-3-ACID ETHYL ESTERS |
| Omega-3-acid ethyl esters | OMEGA-3-ACID ETHYL ESTERS | A-S Medication Solutions | 730e47e0-d2eb-46c5-8be7-1d0cd5b4a6fa | 2024-02-18 | Warnings, Adverse reactions | OMEGA-3-ACID ETHYL ESTERS |
| Omega-3-acid ethyl esters | OMEGA-3-ACID ETHYL ESTERS | A-S Medication Solutions | b11807f8-4301-4f91-8a7a-53226f945c49 | 2024-01-21 | Warnings, Adverse reactions | OMEGA-3-ACID ETHYL ESTERS |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0173-0783 | LOVAZA | omega-3-acid ethyl esters | GlaxoSmithKline LLC | NDA | Current |
| 0173-0783 | LOVAZA | omega-3-acid ethyl esters | GlaxoSmithKline LLC | NDA | Current |
| 0173-0884 | LOVAZA | omega-3-acid ethyl esters | GlaxoSmithKline LLC | NDA | Current |
| 0173-0884 | LOVAZA | omega-3-acid ethyl esters | GlaxoSmithKline LLC | NDA | Current |
| 0173-0884 | LOVAZA | omega-3-acid ethyl esters | GlaxoSmithKline LLC | NDA | Current |
| 17856-0084 | LOVAZA | omega-3-acid ethyl esters | Atlantic Biologicals Corps | NDA | Current |
| 17856-0783 | LOVAZA | omega-3-acid ethyl esters | Atlantic Biologicals Corps | NDA | Current |
| 21695-795 | LOVAZA | omega-3-acid ethyl esters | Rebel Distributors Corp | NDA | Current |
| 66993-726 | Omega-3-acid ethyl esters | omega-3-acid ethyl esters | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-839 | Omega-3-acid ethyl esters | omega-3-acid ethyl esters | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 64525 | SUPPL | 2020-09-08 |
| 64524 | SUPPL | 2020-09-08 |
| 58311 | SUPPL | 2019-04-12 |
| 58209 | SUPPL | 2019-04-04 |
| 15929 | SUPPL | 2014-05-14 |
| 5928 | SUPPL | 2014-05-14 |
| 15928 | SUPPL | 2013-09-17 |
| 37407 | SUPPL | 2013-07-08 |
| 5927 | SUPPL | 2013-06-27 |
| 37406 | SUPPL | 2012-09-06 |
| 28319 | SUPPL | 2012-09-06 |
| 42254 | SUPPL | 2011-12-14 |
| 5926 | SUPPL | 2011-09-21 |
| 5925 | SUPPL | 2010-12-28 |
| 15927 | SUPPL | 2010-12-26 |
| 21768 | SUPPL | 2009-11-19 |
| 5924 | SUPPL | 2009-11-10 |
| 15926 | SUPPL | 2009-09-21 |
| 37405 | SUPPL | 2009-04-23 |
| 28318 | SUPPL | 2009-04-21 |
| 15925 | SUPPL | 2008-06-19 |
| 5923 | SUPPL | 2008-06-06 |
| 28317 | SUPPL | 2008-01-09 |
| 5921 | SUPPL | 2007-11-08 |
| 44607 | SUPPL | 2007-11-07 |
| 5922 | SUPPL | 2007-07-05 |
| 5920 | SUPPL | 2007-02-12 |
| 37404 | SUPPL | 2007-02-02 |
| 28316 | SUPPL | 2006-07-13 |
| 42253 | ORIG | 2005-01-11 |
| 28315 | ORIG | 2004-11-16 |
| 15924 | ORIG | 2004-11-16 |