Application 205606
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | No | No |
| 002 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205606-001 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | |
| A205606-002 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205606-001 | AB |
| A205606-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A205606-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205606-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205606-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205606-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205606-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205606-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205606-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205606-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205606-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205606-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205606-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205606-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205606-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205606-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205606-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205606-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205606-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205606-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205606-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205606-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205606-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205606-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205606-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205606-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205606-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205606-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205606-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205606-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A205606-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A205606-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205606-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205606-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A205606-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A205606-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A205606-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A205606-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A205606-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A205606-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A205606-001 | ESOMEPRAZOLE MAGNESIUM | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A205606-002 | ESOMEPRAZOLE MAGNESIUM | EQ 40MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2016-04-21 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A205606-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205606-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A205606-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205606-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205606-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205606-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A205606-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205606-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205606-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205606-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205606-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205606-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205606-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205606-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205606-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205606-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205606-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205606-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205606-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205606-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A205606-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205606-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205606-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205606-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205606-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205606-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205606-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205606-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A205606-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A205606-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205606-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205606-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A205606-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A205606-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A205606-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A205606-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A205606-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A205606-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A205606-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A205606-002 | AB | 1 | bb7c543d1eb4… |
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 |
|---|---|---|---|---|---|---|
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | A-S Medication Solutions | 71a4fa85-032b-4f50-a2ee-fd9642ae8b15 | 2026-07-23 | Warnings, Adverse reactions | 205606 ANDA205606 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | A-S Medication Solutions | 6ad71713-39da-460b-81fc-e5fba103b215 | 2026-06-23 | Warnings, Adverse reactions | 205606 ANDA205606 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | NCS HealthCare of KY, LLC dba Vangard Labs | 28fbfa02-6c7b-4eb1-af24-86825e652326 | 2026-04-14 | Warnings, Adverse reactions | 205606 ANDA205606 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | PD-Rx Pharmaceuticals, Inc. | ac12cd05-10cf-4694-a9e8-e5f04fe162a7 | 2025-06-20 | Warnings, Adverse reactions | 205606 ANDA205606 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | Aurobindo Pharma Limited | 7038a0bc-99b2-4a6e-9b9a-0646ec187706 | 2025-04-08 | Warnings, Adverse reactions | 205606 ANDA205606 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | Aurobindo Pharma Limited | f4ae091d-9b74-4a0e-ac68-057effd91e17 | 2025-03-26 | Warnings, Adverse reactions | 205606 ANDA205606 65862-783 65862-784 |
| Esomeprazole Magnesium DR | ESOMEPRAZOLE MAGNESIUM | Advanced Rx Pharmacy of Tennessee, LLC | b4cd8ed1-d9d1-5b57-e053-2995a90a9f3c | 2024-12-31 | Warnings, Adverse reactions | 205606 ANDA205606 80425-0111 |
| Esomeprazole Magnesium | ESOMEPRAZOLE MAGNESIUM | Bryant Ranch Prepack | 009794ae-8199-4176-9dc6-4c5e752d845c | 2024-07-09 | Warnings, Adverse reactions | 205606 ANDA205606 71335-0807 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0615-8396 | Esomeprazole Magnesium | Esomeprazole Magnesium | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 16714-735 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-735 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-735 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-735 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-735 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-735 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-735 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-736 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-736 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-736 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-736 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-736 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-736 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-736 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 45865-892 | Esomeprazole Magnesium | Esomeprazole Magnesium | medsourcer pharmaceuticals | ANDA | Current |
| 55700-889 | Esomeprazole Magnesium | Esomeprazole Magnesium | Quality Care Products, LLC | ANDA | Current |
| 65862-783 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-783 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-783 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-783 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-783 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-783 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-783 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-784 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-784 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-784 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-784 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-784 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-784 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-784 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 68071-4212 | Esomeprazole Magnesium | Esomeprazole Magnesium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4457 | Esomeprazole Magnesium | Esomeprazole Magnesium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4536 | Esomeprazole Magnesium | Esomeprazole Magnesium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4536 | Esomeprazole Magnesium | Esomeprazole Magnesium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7201 | Esomeprazole Magnesium | Esomeprazole Magnesium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7201 | Esomeprazole Magnesium | Esomeprazole Magnesium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7201 | Esomeprazole Magnesium | Esomeprazole Magnesium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7326 | Esomeprazole Magnesium | Esomeprazole Magnesium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7623 | Esomeprazole Magnesium | Esomeprazole Magnesium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 71335-0807 | Esomeprazole Magnesium | Esomeprazole Magnesium | Bryant Ranch Prepack | ANDA | Current |
| 71335-0807 | Esomeprazole Magnesium | Esomeprazole Magnesium | Bryant Ranch Prepack | ANDA | Current |
| 71335-0807 | Esomeprazole Magnesium | Esomeprazole Magnesium | Bryant Ranch Prepack | ANDA | Current |
| 71335-0807 | Esomeprazole Magnesium | Esomeprazole Magnesium | Bryant Ranch Prepack | ANDA | Current |
| 71335-0807 | Esomeprazole Magnesium | Esomeprazole Magnesium | Bryant Ranch Prepack | ANDA | Current |
| 80425-0111 | Nexium | Esomeprazole Magnesium 20mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0111 | Nexium | Esomeprazole Magnesium 20mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0111 | Esomeprazole Magnesium | Esomeprazole Magnesium | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0111 | Esomeprazole Magnesium | Esomeprazole Magnesium | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0111 | Esomeprazole Magnesium | Esomeprazole Magnesium | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |