Application 209339
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
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 |
|---|---|---|---|---|---|---|---|
| A209339-001 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 |
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 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A209339-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED RELEASE / ORAL | 2017-10-16 | 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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0363-0508 | Esomeprazole Magnesium | Esomeprazole Magnesium | WALGREEN CO. | ANDA | Current |
| 0363-0508 | Esomeprazole Magnesium | Esomeprazole Magnesium | WALGREEN CO. | ANDA | Current |
| 0363-0508 | Esomeprazole Magnesium | Esomeprazole Magnesium | WALGREEN CO. | ANDA | Current |
| 0363-0508 | Esomeprazole Magnesium | Esomeprazole Magnesium | WALGREEN CO. | ANDA | Current |
| 0363-0508 | Esomeprazole Magnesium | Esomeprazole Magnesium | WALGREEN CO. | ANDA | Current |
| 0363-0508 | Esomeprazole Magnesium | Esomeprazole Magnesium | WALGREEN CO. | ANDA | Current |
| 21130-100 | Esomeprazole Magnesium | Esomeprazole Magnesium | Better Living Brands LLC | ANDA | Current |
| 21130-100 | Esomeprazole Magnesium | Esomeprazole Magnesium | Better Living Brands LLC | ANDA | Current |
| 46122-538 | Esomeprazole Magnesium | Esomeprazole Magnesium | Amerisource Bergen | ANDA | Current |
| 46122-538 | Esomeprazole Magnesium | Esomeprazole Magnesium | Amerisource Bergen | ANDA | Current |
| 46122-538 | Esomeprazole Magnesium | Esomeprazole Magnesium | Amerisource Bergen | ANDA | Current |
| 46122-538 | Esomeprazole Magnesium | Esomeprazole Magnesium | Amerisource Bergen | ANDA | Current |
| 49035-980 | Esomeprazole Magnesium | Esomeprazole Magnesium | Wal-Mart Stores, Inc. | ANDA | Current |
| 49035-980 | Esomeprazole Magnesium | Esomeprazole Magnesium | Wal-Mart Stores, Inc. | ANDA | Current |
| 49035-980 | Esomeprazole Magnesium | Esomeprazole Magnesium | Wal-Mart Stores, Inc. | ANDA | Current |
| 49035-980 | Esomeprazole Magnesium | Esomeprazole Magnesium | Wal-Mart Stores, Inc. | ANDA | Current |
| 49035-980 | Esomeprazole Magnesium | Esomeprazole Magnesium | Wal-Mart Stores, Inc. | ANDA | Current |
| 50066-923 | GENOZOL | Esomeprazole Magnesium | Genomma Lab USA Inc | ANDA | Current |
| 50066-923 | GENOZOL | Esomeprazole Magnesium | Genomma Lab USA Inc | ANDA | Current |
| 50066-923 | GENOZOL | Esomeprazole Magnesium | Genomma Lab USA Inc | ANDA | Current |
| 50066-923 | GENOZOL | Esomeprazole Magnesium | Genomma Lab USA Inc | ANDA | Current |
| 50066-923 | GENOZOL | Esomeprazole Magnesium | Genomma Lab USA Inc | ANDA | Current |
| 53943-890 | Esomeprazole Magnesium | Esomeprazole Magnesium | DISCOUNT DRUG MART | ANDA | Current |
| 53943-890 | Esomeprazole Magnesium | Esomeprazole Magnesium | DISCOUNT DRUG MART | ANDA | Current |
| 53943-890 | Esomeprazole Magnesium | Esomeprazole Magnesium | DISCOUNT DRUG MART | ANDA | Current |
| 53943-890 | Esomeprazole Magnesium | Esomeprazole Magnesium | DISCOUNT DRUG MART | ANDA | Current |
| 55315-010 | Esomeprazole Magnesium | Esomeprazole Magnesium | Fred's, Inc. | ANDA | Current |
| 55315-010 | Esomeprazole Magnesium | Esomeprazole Magnesium | Fred's, Inc. | ANDA | Current |
| 55315-010 | Esomeprazole Magnesium | Esomeprazole Magnesium | Fred's, Inc. | ANDA | Current |
| 55319-988 | Esomeprazole Magnesium | Esomeprazole Magnesium | Family Dollar, Inc. | ANDA | Current |
| 55319-988 | Esomeprazole Magnesium | Esomeprazole Magnesium | Family Dollar, Inc. | ANDA | Current |
| 55319-988 | Esomeprazole Magnesium | Esomeprazole Magnesium | Family Dollar, Inc. | ANDA | Current |
| 55319-988 | Esomeprazole Magnesium | Esomeprazole Magnesium | Family Dollar, Inc. | ANDA | Current |
| 55910-016 | Esomeprazole Magnesium | Esomeprazole Magnesium | Dolgencorp, LLC | ANDA | Current |
| 55910-016 | Esomeprazole Magnesium | Esomeprazole Magnesium | Dolgencorp, LLC | ANDA | Current |
| 55910-016 | Esomeprazole Magnesium | Esomeprazole Magnesium | Dolgencorp, LLC | ANDA | Current |
| 55910-016 | Esomeprazole Magnesium | Esomeprazole Magnesium | Dolgencorp, LLC | ANDA | Current |
| 56062-020 | Esomeprazole Magnesium | Esomeprazole Magnesium | Publix | ANDA | Current |
| 56062-020 | Esomeprazole Magnesium | Esomeprazole Magnesium | Publix | ANDA | Current |
| 56062-020 | Esomeprazole Magnesium | Esomeprazole Magnesium | Publix | ANDA | Current |
| 58602-809 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurohealth LLC | ANDA | Current |
| 58602-809 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurohealth LLC | ANDA | Current |
| 58602-809 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurohealth LLC | ANDA | Current |
| 58602-809 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurohealth LLC | ANDA | Current |
| 58602-809 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurohealth LLC | ANDA | Current |
| 58602-809 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurohealth LLC | ANDA | Current |
| 58602-809 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurohealth LLC | ANDA | Current |
| 58602-822 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurohealth LLC | ANDA | Current |
| 58602-822 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurohealth LLC | ANDA | Current |
| 58602-822 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurohealth LLC | ANDA | Current |
| 58602-822 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurohealth LLC | ANDA | Current |
| 58602-822 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurohealth LLC | ANDA | Current |
| 58602-846 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurohealth LLC | ANDA | Current |
| 58602-846 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurohealth LLC | ANDA | Current |
| 58602-846 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurohealth LLC | ANDA | Current |
| 60000-109 | Esomeprazole Magnesium | Esomeprazole Magnesium | Ahold U.S.A., Inc, | ANDA | Current |
| 60000-109 | Esomeprazole Magnesium | Esomeprazole Magnesium | Ahold U.S.A., Inc, | ANDA | Current |
| 60000-109 | Esomeprazole Magnesium | Esomeprazole Magnesium | Ahold U.S.A., Inc, | ANDA | Current |
| 62011-0402 | Esomeprazole Magnesium | Esomeprazole Magnesium | McKESSON Corporation | ANDA | Current |
| 63941-971 | Esomeprazole Magnesium | Esomeprazole Magnesium | Best Choice | ANDA | Current |
| 63941-971 | Esomeprazole Magnesium | Esomeprazole Magnesium | Best Choice | ANDA | Current |
| 63941-971 | Esomeprazole Magnesium | Esomeprazole Magnesium | Best Choice | ANDA | Current |
| 63941-971 | Esomeprazole Magnesium | Esomeprazole Magnesium | Best Choice | ANDA | Current |
| 68016-007 | Esomeprazole Magnesium | Esomeprazole Magnesium | Chain Drug Consortium, LLC | ANDA | Current |
| 68016-007 | Esomeprazole Magnesium | Esomeprazole Magnesium | Chain Drug Consortium, LLC | ANDA | Current |
| 68016-007 | Esomeprazole Magnesium | Esomeprazole Magnesium | Chain Drug Consortium, LLC | ANDA | Current |
| 68016-007 | Esomeprazole Magnesium | Esomeprazole Magnesium | Chain Drug Consortium, LLC | ANDA | Current |
| 68196-977 | Esomeprazole Magnesium | Esomeprazole Magnesium | Sam's West Inc | ANDA | Current |
| 68196-977 | Esomeprazole Magnesium | Esomeprazole Magnesium | Sam's West Inc | ANDA | Current |
| 68196-977 | Esomeprazole Magnesium | Esomeprazole Magnesium | Sam's West Inc | ANDA | Current |
| 68196-977 | Esomeprazole Magnesium | Esomeprazole Magnesium | Sam's West Inc | ANDA | Current |
| 68196-977 | Esomeprazole Magnesium | Esomeprazole Magnesium | Sam's West Inc | ANDA | Current |
| 69842-248 | Esomeprazole Magnesium | Esomeprazole Magnesium | CVS Pharmacy, Inc. | ANDA | Current |
| 69842-248 | Esomeprazole Magnesium | Esomeprazole Magnesium | CVS Pharmacy, Inc. | ANDA | Current |
| 69842-248 | Esomeprazole Magnesium | Esomeprazole Magnesium | CVS Pharmacy, Inc. | ANDA | Current |
| 69842-248 | Esomeprazole Magnesium | Esomeprazole Magnesium | CVS Pharmacy, Inc. | ANDA | Current |
| 69842-248 | Esomeprazole Magnesium | Esomeprazole Magnesium | CVS Pharmacy, Inc. | ANDA | Current |
| 70677-0069 | Esomeprazole Magnesium | Esomeprazole Magnesium | McKESSON Corporation | ANDA | Current |
| 72036-800 | Esomeprazole Magnesium | Esomeprazole Magnesium | Harris Teeter | ANDA | Current |
| 72036-800 | Esomeprazole Magnesium | Esomeprazole Magnesium | Harris Teeter | ANDA | Current |