Application 204470
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | TABLET, DELAYED RELEASE;ORAL | EQ 20MG BASE;375MG | No | No |
| 002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | TABLET, DELAYED RELEASE;ORAL | EQ 20MG BASE;500MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204470-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | ||
| A204470-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 |
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 | A204470-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204470-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204470-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204470-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204470-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204470-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204470-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204470-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204470-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204470-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204470-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204470-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204470-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204470-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204470-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204470-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204470-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204470-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204470-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204470-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204470-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204470-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204470-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204470-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204470-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204470-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A204470-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A204470-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A204470-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A204470-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A204470-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A204470-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A204470-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A204470-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A204470-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A204470-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A204470-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A204470-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A204470-001 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A204470-002 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | 2022-08-24 | a67488948f0b… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-01-26 05:58 UTC | 2023-01 | A204470-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A204470-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A204470-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A204470-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A204470-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A204470-002 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A204470-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A204470-002 | AB | 1 | e64feba35796… |
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 |
|---|---|---|---|---|---|---|
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Preferred Pharmaceuticals Inc. | 65b892f2-8385-4bb0-8121-a58b01e8d13d | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | Naproxen and esomeprazole magnesium |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Proficient Rx LP | cfd4ef00-cfc4-4794-99fe-faa45eb2f617 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | Naproxen and esomeprazole magnesium |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Doc Rx | 733a93ff-8240-4afa-ba28-b0a6f8514efe | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | Naproxen and esomeprazole magnesium |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Proficient Rx LP | 5fd008ef-8388-48e9-8d38-76e0106bd5b6 | 2026-04-01 | Boxed warning, Warnings, Adverse reactions | Naproxen and esomeprazole magnesium |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | PHOENIX RX LLC | 4c25c106-b5ca-079f-e063-6394a90a4978 | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | Naproxen and esomeprazole magnesium |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Preferred Pharmaceuticals Inc. | b295a90e-320f-4414-b80a-d11f06c00c96 | 2026-01-20 | Boxed warning, Warnings, Adverse reactions | Naproxen and esomeprazole magnesium |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Ajanta Pharma USA Inc. | 7ca657dc-4376-4693-8568-99351fac8186 | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | Naproxen and esomeprazole magnesium |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Preferred Pharmaceuticals Inc. | 6368a3be-4b79-466b-8ec4-11fc3ac623cc | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | Naproxen and esomeprazole magnesium |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | PHOENIX RX LLC | 3a652450-525b-4839-e063-6294a90ac287 | 2025-08-14 | Boxed warning, Warnings, Adverse reactions | Naproxen and esomeprazole magnesium |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Preferred Pharmaceuticals Inc | 470496f5-a71d-40b2-bf11-3a8d3d790962 | 2025-07-31 | Boxed warning, Warnings, Adverse reactions | Naproxen and esomeprazole magnesium |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | PHOENIX RX LLC | 3a6637ca-0c55-f648-e063-6294a90aaef7 | 2025-07-20 | Boxed warning, Warnings, Adverse reactions | Naproxen and esomeprazole magnesium |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | ScieGen Pharmaceuticals, Inc | 167340c2-1234-4d00-b4e2-cccf3d270fda | 2025-03-06 | Boxed warning, Warnings, Adverse reactions | Naproxen and esomeprazole magnesium |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Bryant Ranch Prepack | 3f1c66f0-2d9d-4be1-8656-1dbed2c9c715 | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | Naproxen and esomeprazole magnesium |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Bryant Ranch Prepack | f3a3eea2-f6b3-4559-8536-26c1125df3e1 | 2025-01-21 | Boxed warning, Warnings, Adverse reactions | Naproxen and esomeprazole magnesium |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Bryant Ranch Prepack | 19aadd4b-647b-4c75-9059-9a2c68a18561 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | Naproxen and esomeprazole magnesium |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Asclemed USA, Inc. | 7b3af5a8-0c92-43f4-af13-7a47dca20e92 | 2024-12-28 | Boxed warning, Warnings, Adverse reactions | Naproxen and esomeprazole magnesium |
| Naproxen and esomeprazole magnesium | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Dr. Reddy's Laboratories Limited | 1ef3fe94-9bbb-934d-a09b-d19a1d23a4d5 | 2024-12-20 | Boxed warning, Warnings, Adverse reactions | Naproxen and esomeprazole magnesium |