Application 022511
- Type
- NDA
- Sponsor
- HORIZON
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VIMOVO | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | TABLET, DELAYED RELEASE;ORAL | EQ 20MG BASE;500MG | Yes | Yes |
| 002 | VIMOVO | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | TABLET, DELAYED RELEASE;ORAL | EQ 20MG BASE;375MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022511-001 | VIMOVO | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | |
| N022511-002 | VIMOVO | ESOMEPRAZOLE MAGNESIUM; NAPROXEN | EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N022511-001 | VIMOVO | EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022511-002 | VIMOVO | EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022511-001 | VIMOVO | EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022511-002 | VIMOVO | EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022511-001 | VIMOVO | EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022511-002 | VIMOVO | EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022511-001 | VIMOVO | EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022511-002 | VIMOVO | EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022511-001 | VIMOVO | EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022511-002 | VIMOVO | EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022511-001 | VIMOVO | EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022511-002 | VIMOVO | EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022511-001 | VIMOVO | EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022511-002 | VIMOVO | EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022511-001 | VIMOVO | EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022511-002 | VIMOVO | EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022511-001 | VIMOVO | EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022511-002 | VIMOVO | EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022511-001 | VIMOVO | EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022511-002 | VIMOVO | EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022511-001 | VIMOVO | EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022511-002 | VIMOVO | EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022511-001 | VIMOVO | EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022511-002 | VIMOVO | EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022511-001 | VIMOVO | EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022511-002 | VIMOVO | EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022511-001 | VIMOVO | EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022511-002 | VIMOVO | EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022511-001 | VIMOVO | EQ 20MG BASE;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N022511-002 | VIMOVO | EQ 20MG BASE;375MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022511-001 | VIMOVO | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-04-30 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022511-002 | VIMOVO | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2010-04-30 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022511-001 | VIMOVO | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-04-30 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022511-002 | VIMOVO | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2010-04-30 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022511-001 | VIMOVO | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-04-30 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N022511-002 | VIMOVO | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2010-04-30 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022511-001 | VIMOVO | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | RLD, RS | 2010-04-30 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022511-002 | VIMOVO | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | RLD | 2010-04-30 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N022511-001 | VIMOVO | EQ 20MG BASE;500MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD, RS | 2010-04-30 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N022511-002 | VIMOVO | EQ 20MG BASE;375MG | TABLET, DELAYED RELEASE / ORAL | AB | RLD | 2010-04-30 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022511-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022511-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022511-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022511-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022511-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N022511-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | N022511-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N022511-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022511-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N022511-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022511-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022511-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022511-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N022511-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N022511-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N022511-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022511-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N022511-002 | AB | 1 | c0c555d07b60… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022511-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N022511-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022511-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N022511-002 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N022511-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | N022511-002 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N022511-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | N022511-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022511-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022511-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N022511-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N022511-002 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N022511-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | N022511-002 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022511-001 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022511-002 | AB | 1 | cb3db0bc1861… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022511-001 | 8852636 | 2022-05-31 | U-1052 | Drug product | 2014-10-29 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022511-001 | 8858996 | 2022-05-31 | U-1052 | Drug product | 2014-10-29 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022511-001 | 9161920 | 2022-05-31 | U-1760 | 2015-11-12 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022511-001 | 9198888 | 2022-05-31 | U-1781 | 2015-12-17 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022511-001 | 9345695 | 2022-05-31 | Drug product | 2016-06-23 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022511-001 | 9707181 | 2022-05-31 | Drug product | 2017-08-17 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022511-001 | 9393208 | 2029-09-03 | U-1781 | 2016-08-17 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022511-001 | 9220698 | 2031-03-10 | U-1781 | 2016-01-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022511-001 | 8945621 | 2031-10-17 | U-1661 | 2015-03-02 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022511-002 | 8852636 | 2022-05-31 | U-1052 | Drug product | 2014-10-29 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022511-002 | 8858996 | 2022-05-31 | U-1052 | Drug product | 2014-10-29 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022511-002 | 9161920 | 2022-05-31 | U-1760 | 2015-11-12 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022511-002 | 9198888 | 2022-05-31 | U-1781 | 2015-12-17 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022511-002 | 9345695 | 2022-05-31 | Drug product | 2016-06-23 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022511-002 | 9707181 | 2022-05-31 | Drug product | 2017-08-17 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022511-002 | 9393208 | 2029-09-03 | U-1781 | 2016-08-17 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022511-002 | 8945621 | 2031-10-17 | U-1661 | 2015-03-02 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022511-001 | 8852636 | 2022-05-31 | U-1052 | Drug product | 2014-10-29 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022511-001 | 8858996 | 2022-05-31 | U-1052 | Drug product | 2014-10-29 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022511-001 | 9161920 | 2022-05-31 | U-1760 | 2015-11-12 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022511-001 | 9198888 | 2022-05-31 | U-1781 | 2015-12-17 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022511-001 | 9345695 | 2022-05-31 | Drug product | 2016-06-23 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022511-001 | 9707181 | 2022-05-31 | Drug product | 2017-08-17 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022511-001 | 9393208 | 2029-09-03 | U-1781 | 2016-08-17 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022511-001 | 9220698 | 2031-03-10 | U-1781 | 2016-01-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022511-001 | 8945621 | 2031-10-17 | U-1661 | 2015-03-02 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022511-002 | 8852636 | 2022-05-31 | U-1052 | Drug product | 2014-10-29 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022511-002 | 8858996 | 2022-05-31 | U-1052 | Drug product | 2014-10-29 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N022511-002 | 9161920 | 2022-05-31 | U-1760 | 2015-11-12 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022511-002 | 9198888 | 2022-05-31 | U-1781 | 2015-12-17 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022511-002 | 9345695 | 2022-05-31 | Drug product | 2016-06-23 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022511-002 | 9707181 | 2022-05-31 | Drug product | 2017-08-17 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022511-002 | 9393208 | 2029-09-03 | U-1781 | 2016-08-17 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022511-002 | 8945621 | 2031-10-17 | U-1661 | 2015-03-02 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022511-001 | 8557285 | 2022-05-31 | Drug product | 2013-10-29 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022511-001 | 8852636 | 2022-05-31 | U-1052 | Drug product | 2014-10-29 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N022511-001 | 8858996 | 2022-05-31 | U-1052 | Drug product | 2014-10-29 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N022511-001 | 9161920 | 2022-05-31 | U-1760 | 2015-11-12 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022511-001 | 9198888 | 2022-05-31 | U-1781 | 2015-12-17 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022511-001 | 9345695 | 2022-05-31 | Drug product | 2016-06-23 | 4b0b4de00fa7… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N022511-001 | NPP | 2020-07-06 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022511-002 | NPP | 2020-07-06 | 74a2ff9319b5… |
| 2020-12-22 03:56 UTC | 2020-12 | N022511-001 | NPP | 2020-07-06 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N022511-002 | NPP | 2020-07-06 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N022511-001 | NPP | 2020-07-06 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N022511-002 | NPP | 2020-07-06 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N022511-001 | NPP | 2020-07-06 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022511-002 | NPP | 2020-07-06 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022511-001 | NPP | 2020-07-06 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022511-002 | NPP | 2020-07-06 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022511-001 | NPP | 2020-07-06 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022511-002 | NPP | 2020-07-06 | ea99ee380514… |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70748-215 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 70748-215 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 70748-215 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 70748-215 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 70748-216 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 70748-216 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 70748-216 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 70748-216 | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | NAPROXEN AND ESOMEPRAZOLE MAGNESIUM | Lupin Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 75987-030 | Vimovo | Naproxen and Esomeprazole Magnesium | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-030 | Vimovo | Naproxen and Esomeprazole Magnesium | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-030 | Vimovo | Naproxen and Esomeprazole Magnesium | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-030 | Vimovo | Naproxen and Esomeprazole Magnesium | Horizon Medicines LLC | NDA | Current |
| 75987-030 | Vimovo | Naproxen and Esomeprazole Magnesium | Horizon Pharma Inc. | NDA | Current |
| 75987-030 | Vimovo | Naproxen and Esomeprazole Magnesium | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-031 | Vimovo | Naproxen and Esomeprazole Magnesium | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-031 | Vimovo | Naproxen and Esomeprazole Magnesium | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-031 | Vimovo | Naproxen and Esomeprazole Magnesium | Horizon Therapeutics USA, Inc. | NDA | Current |
| 75987-031 | Vimovo | Naproxen and Esomeprazole Magnesium | Horizon Medicines LLC | NDA | Current |
| 75987-031 | Vimovo | Naproxen and Esomeprazole Magnesium | Horizon Pharma Inc. | NDA | Current |
| 75987-031 | Vimovo | Naproxen and Esomeprazole Magnesium | Horizon Therapeutics USA, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80412 | SUPPL | 2024-11-25 |
| 80411 | SUPPL | 2024-11-25 |
| 80311 | SUPPL | 2024-11-22 |
| 74823 | SUPPL | 2023-07-20 |
| 74782 | SUPPL | 2023-07-19 |
| 70449 | SUPPL | 2022-03-09 |
| 70444 | SUPPL | 2022-03-09 |
| 70429 | SUPPL | 2022-03-07 |
| 67368 | SUPPL | 2021-05-03 |
| 67367 | SUPPL | 2021-05-03 |
| 67277 | SUPPL | 2021-04-30 |
| 65396 | SUPPL | 2020-11-30 |
| 65395 | SUPPL | 2020-11-30 |
| 65388 | SUPPL | 2020-11-30 |
| 59446 | SUPPL | 2019-07-25 |
| 59408 | SUPPL | 2019-07-23 |
| 59407 | SUPPL | 2019-07-23 |
| 54582 | SUPPL | 2018-06-14 |
| 54528 | SUPPL | 2018-06-12 |
| 54527 | SUPPL | 2018-06-12 |
| 48937 | SUPPL | 2017-07-10 |
| 48928 | SUPPL | 2017-07-07 |
| 45727 | SUPPL | 2016-11-10 |
| 45651 | SUPPL | 2016-11-10 |
| 17663 | SUPPL | 2016-05-11 |
| 7477 | SUPPL | 2016-05-10 |
| 38784 | SUPPL | 2015-06-23 |
| 7476 | SUPPL | 2015-06-23 |
| 38783 | SUPPL | 2015-05-08 |
| 29803 | SUPPL | 2015-03-26 |
| 38785 | SUPPL | 2014-12-29 |
| 29804 | SUPPL | 2014-12-23 |
| 38782 | SUPPL | 2014-04-01 |
| 7475 | SUPPL | 2014-03-28 |
| 29802 | SUPPL | 2014-02-27 |
| 17662 | SUPPL | 2014-02-27 |
| 17661 | SUPPL | 2012-10-12 |
| 29801 | SUPPL | 2012-10-11 |
| 17660 | SUPPL | 2012-10-04 |
| 29800 | SUPPL | 2012-10-03 |
| 38781 | SUPPL | 2012-01-24 |
| 7474 | SUPPL | 2012-01-23 |
| 23711 | ORIG | 2011-12-20 |
| 38778 | SUPPL | 2011-11-29 |
| 29797 | SUPPL | 2011-11-22 |
| 38779 | SUPPL | 2011-06-29 |
| 29798 | SUPPL | 2011-06-29 |
| 17659 | SUPPL | 2011-06-29 |
| 7473 | SUPPL | 2011-06-29 |
| 38780 | SUPPL | 2011-05-26 |
| 29799 | SUPPL | 2011-05-25 |
| 44766 | ORIG | 2011-02-28 |
| 22041 | ORIG | 2011-02-28 |
| 38777 | ORIG | 2010-05-07 |
| 7472 | ORIG | 2010-05-07 |
| 51398 | ORIG | 1900-01-01 |
| 51397 | ORIG | 1900-01-01 |