Application 207193
- Type
- ANDA
- Sponsor
- PERRIGO R AND D
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED RELEASE;ORAL | EQ 20MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207193-001 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 |
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 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A207193-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-08-18 | 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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0113-0651 | good sense esomeprazole magnesium | esomeprazole | L. Perrigo Company | ANDA | Current |
| 0113-0732 | basic care esomeprazole magnesium | Esomeprazole | L. Perrigo Company | ANDA | Current |
| 0113-0732 | basic care esomeprazole magnesium | Esomeprazole | L. Perrigo Company | ANDA | Current |
| 0113-0732 | basic care esomeprazole magnesium | Esomeprazole | L. Perrigo Company | ANDA | Current |
| 0113-0898 | Good Sense Esomeprazole Magnesium | Esomeprazole | L. Perrigo Company | ANDA | Current |
| 0113-0898 | Good Sense Esomeprazole Magnesium | Esomeprazole | L. Perrigo Company | ANDA | Current |
| 0113-0898 | Good Sense Esomeprazole Magnesium | Esomeprazole | L. Perrigo Company | ANDA | Current |
| 0363-1699 | Esomeprazole Magnesium | esomeprazole | Walgreen Company | ANDA | Current |
| 0363-1699 | Esomeprazole Magnesium | esomeprazole | Walgreen Company | ANDA | Current |
| 0363-1699 | Esomeprazole Magnesium | esomeprazole | Walgreen Company | ANDA | Current |
| 0363-1898 | esomeprazole magnesium | Esomeprazole | Walgreen Company | ANDA | Current |
| 0363-1898 | esomeprazole magnesium | Esomeprazole | Walgreen Company | ANDA | Current |
| 0536-1131 | rugby esomeprazole magnesium | Esomeprazole | Rugby Laboratories | ANDA | Current |
| 0536-1131 | rugby esomeprazole magnesium | Esomeprazole | Rugby Laboratories | ANDA | Current |
| 11673-753 | Up and Up Esomeprazole Magnesium | esomeprazole magnesium | Target Corporation | ANDA | Current |
| 11673-753 | Up and Up Esomeprazole Magnesium | esomeprazole magnesium | Target Corporation | ANDA | Current |
| 11673-898 | up and up esomeprazole magnesium | Esomeprazole | Target Corporation | ANDA | Current |
| 11673-898 | up and up esomeprazole magnesium | Esomeprazole | Target Corporation | ANDA | Current |
| 11673-898 | up and up esomeprazole magnesium | Esomeprazole | Target Corporation | ANDA | Current |
| 11673-898 | up and up esomeprazole magnesium | Esomeprazole | Target Corporation | ANDA | Current |
| 11673-898 | up and up esomeprazole magnesium | Esomeprazole | Target Corporation | ANDA | Current |
| 11822-0024 | esomeprazole magnesium | esomeprazole | Rite Aid Corporation | ANDA | Current |
| 11822-0898 | esomeprazole magnesium | Esomeprazole | Rite Aid Corporation | ANDA | Current |
| 11822-0898 | esomeprazole magnesium | Esomeprazole | Rite Aid Corporation | ANDA | Current |
| 11822-0898 | esomeprazole magnesium | Esomeprazole | Rite Aid Corporation | ANDA | Current |
| 21130-088 | signature care esomeprazole magnesium | Esomeprazole | Safeway | ANDA | Current |
| 21130-088 | signature care esomeprazole magnesium | Esomeprazole | Safeway | ANDA | Current |
| 21130-088 | signature care esomeprazole magnesium | Esomeprazole | Safeway | ANDA | Current |
| 21130-714 | signature care esomeprazole magnesium | esomeprazole | Safeway | ANDA | Current |
| 30142-273 | esomeprazole magnesium | esomeprazole | Kroger Company | ANDA | Current |
| 30142-413 | esomeprazole magnesium | Esomeprazole | Kroger Company | ANDA | Current |
| 30142-413 | esomeprazole magnesium | Esomeprazole | Kroger Company | ANDA | Current |
| 36800-627 | topcare esomeprazole magnesium | esomeprazole magnesium | Topco Associates LLC | ANDA | Current |
| 36800-627 | topcare esomeprazole magnesium | esomeprazole magnesium | Topco Associates LLC | ANDA | Current |
| 36800-636 | Topcare Esomeprazole Magnesium | Esomeprazole | Topco Associates LLC | ANDA | Current |
| 36800-636 | Topcare Esomeprazole Magnesium | Esomeprazole | Topco Associates LLC | ANDA | Current |
| 36800-636 | Topcare Esomeprazole Magnesium | Esomeprazole | Topco Associates LLC | ANDA | Current |
| 36800-636 | Topcare Esomeprazole Magnesium | Esomeprazole | Topco Associates LLC | ANDA | Current |
| 37012-898 | esomeprazole magnesium | Esomeprazole | Shopko Stores Operating Co., LLC | ANDA | Current |
| 37012-898 | esomeprazole magnesium | Esomeprazole | Shopko Stores Operating Co., LLC | ANDA | Current |
| 37808-719 | Esomeprazole Magnesium | esomeprazole | H E B | ANDA | Current |
| 37808-898 | esomeprazole magnesium | Esomeprazole | H E B | ANDA | Current |
| 41163-539 | equaline esomeprazole magnesium | Esomeprazole | Supervalu Inc | ANDA | Current |
| 41163-539 | equaline esomeprazole magnesium | Esomeprazole | Supervalu Inc | ANDA | Current |
| 41163-539 | equaline esomeprazole magnesium | Esomeprazole | Supervalu Inc | ANDA | Current |
| 41163-539 | equaline esomeprazole magnesium | Esomeprazole | Supervalu Inc | ANDA | Current |
| 41190-898 | shoprite esomeprazole magnesium | Esomeprazole | Wakefern Food Corporation | ANDA | Current |
| 41190-898 | shoprite esomeprazole magnesium | Esomeprazole | Wakefern Food Corporation | ANDA | Current |
| 41250-727 | esomeprazole magnesium | esomeprazole magnesium | Meijer Distribution Inc | ANDA | Current |
| 41250-900 | esomeprazole magnesium | Esomeprazole | Meijer Distribution Inc | ANDA | Current |
| 41250-900 | esomeprazole magnesium | Esomeprazole | Meijer Distribution Inc | ANDA | Current |
| 41250-900 | esomeprazole magnesium | Esomeprazole | Meijer Distribution Inc | ANDA | Current |
| 41520-727 | careone esomeprazole magnesium | Esomeprazole | American Sales Company | ANDA | Current |
| 41520-727 | careone esomeprazole magnesium | Esomeprazole | American Sales Company | ANDA | Current |
| 46122-397 | Good Neighbor Pharmacy Esomeprazole Magnesium | Esomeprazole | Amerisource Bergen | ANDA | Current |
| 46122-397 | Good Neighbor Pharmacy Esomeprazole Magnesium | Esomeprazole | Amerisource Bergen | ANDA | Current |
| 46122-641 | Good Neighbor Pharmacy Esomeprazole Magnesium | esomeprazole | Amerisource Bergen | ANDA | Current |
| 46122-648 | good neighbor pharmacy esomeprazole magnesium | Esomeprazole | Amerisource Bergen | ANDA | Current |
| 49035-921 | equate esomeprazole magnesium | Esomeprazole | Wal-Mart Stores Inc | ANDA | Current |
| 49035-921 | equate esomeprazole magnesium | Esomeprazole | Wal-Mart Stores Inc | ANDA | Current |
| 49738-898 | smart sense esomeprazole magnesium | Esomeprazole | Kmart Corporation | ANDA | Current |
| 49738-898 | smart sense esomeprazole magnesium | Esomeprazole | Kmart Corporation | ANDA | Current |
| 50594-029 | sound body esomeprazole magnesium | Esomeprazole | Big Lots Stores, Inc. | ANDA | Current |
| 50594-029 | sound body esomeprazole magnesium | Esomeprazole | Big Lots Stores, Inc. | ANDA | Current |
| 50594-029 | sound body esomeprazole magnesium | Esomeprazole | Big Lots Stores, Inc. | ANDA | Current |
| 55301-898 | Exchange Select Esomeprazole Magnesium | Esomeprazole | Army & Air Force Exchange Service | ANDA | Current |
| 55301-898 | Exchange Select Esomeprazole Magnesium | Esomeprazole | Army & Air Force Exchange Service | ANDA | Current |
| 55301-898 | Exchange Select Esomeprazole Magnesium | Esomeprazole | Army & Air Force Exchange Service | ANDA | Current |
| 55316-898 | healthy accents esomeprazole magnesium | Esomeprazole | DZA Brands LLC | ANDA | Current |
| 55316-898 | healthy accents esomeprazole magnesium | Esomeprazole | DZA Brands LLC | ANDA | Current |
| 55319-898 | Family Wellness Esomeprazole Magnesium | Esomeprazole | Family Dollar Services Inc | ANDA | Current |
| 55319-898 | Family Wellness Esomeprazole Magnesium | Esomeprazole | Family Dollar Services Inc | ANDA | Current |
| 55910-250 | dg health esomeprazole magnesium | esomeprazole | Dolgencorp, LLC | ANDA | Current |
| 55910-250 | dg health esomeprazole magnesium | esomeprazole | Dolgencorp, LLC | ANDA | Current |
| 55910-593 | DG Health Esomeprazole Magnesium | Esomeprazole | Dolgencorp, LLC | ANDA | Current |
| 55910-593 | DG Health Esomeprazole Magnesium | Esomeprazole | Dolgencorp, LLC | ANDA | Current |
| 55910-593 | DG Health Esomeprazole Magnesium | Esomeprazole | Dolgencorp, LLC | ANDA | Current |
| 55910-593 | DG Health Esomeprazole Magnesium | Esomeprazole | Dolgencorp, LLC | ANDA | Current |
| 56062-898 | Esomeprazole Magnesium | Esomeprazole | Publix Super Markets Inc | ANDA | Current |
| 62011-0332 | health mart esomeprazole magnesium | Esomeprazole | Strategic Sourcing Services LLC | ANDA | Current |