Application 203270
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OMEPRAZOLE | OMEPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 10MG | No | No |
| 002 | OMEPRAZOLE | OMEPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 20MG | No | No |
| 003 | OMEPRAZOLE | OMEPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 40MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203270-001 | OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | |
| A203270-002 | OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | |
| A203270-003 | OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203270-001 | AB |
| A203270-002 | AB |
| A203270-003 | 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 | A203270-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203270-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203270-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203270-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203270-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203270-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203270-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203270-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203270-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203270-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203270-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203270-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203270-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203270-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203270-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203270-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203270-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203270-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203270-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203270-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203270-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203270-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203270-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203270-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203270-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203270-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203270-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203270-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203270-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203270-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203270-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203270-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203270-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203270-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203270-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203270-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203270-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203270-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203270-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203270-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2015-08-19 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A203270-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203270-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203270-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A203270-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203270-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203270-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203270-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203270-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203270-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203270-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203270-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203270-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203270-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203270-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203270-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203270-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203270-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203270-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203270-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203270-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203270-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203270-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203270-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203270-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203270-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203270-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203270-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203270-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203270-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203270-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203270-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203270-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203270-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203270-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203270-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203270-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203270-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203270-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203270-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203270-001 | AB | 1 | 1e350fbaab3a… |
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 |
|---|---|---|---|---|---|---|
| Omeprazole | OMEPRAZOLE | QPharma Inc | 50115204-74f7-17c1-e063-6394a90ab665 | 2026-06-08 | Warnings, Adverse reactions | 203270 ANDA203270 |
| Omeprazole | OMEPRAZOLE | Preferred Phharmaceuticals Inc. | 319d990e-161b-4c16-b026-f55c413c7e8f | 2026-04-21 | Warnings, Adverse reactions | 203270 ANDA203270 |
| Omeprazole | OMEPRAZOLE | Proficient Rx LP | 61eab342-61fd-471f-8f70-95f9cbca0097 | 2026-04-01 | Warnings, Adverse reactions | 203270 ANDA203270 |
| Omeprazole | OMEPRAZOLE | A-S Medication Solutions | c1276463-7357-45b5-9f7e-8d3c4a550ff4 | 2026-03-18 | Warnings, Adverse reactions | 203270 ANDA203270 |
| Omeprazole | OMEPRAZOLE | A-S Medication Solutions | df1a4294-3893-4a11-b4d5-f3536678087e | 2026-03-18 | Warnings, Adverse reactions | 203270 ANDA203270 |
| Omeprazole | OMEPRAZOLE | NuCare Pharmaceuticals,Inc. | af707c0a-5193-3f83-e053-2995a90a78ef | 2026-03-11 | Warnings, Adverse reactions | 203270 ANDA203270 |
| Omeprazole | OMEPRAZOLE | Northwind Health Company, LLC | 10a3fbc9-00c6-ad83-e063-6294a90ae1ad | 2026-01-05 | Warnings, Adverse reactions | 203270 ANDA203270 |
| Omeprazole | OMEPRAZOLE | Northwind Health Company, LLC | f3038133-8bb2-044e-e053-2995a90a6e7d | 2026-01-01 | Warnings, Adverse reactions | 203270 ANDA203270 |
| Omeprazole | OMEPRAZOLE | QPharma, Inc. | f5dd5d63-1376-1ff7-e053-2a95a90a1d94 | 2025-12-03 | Warnings, Adverse reactions | 203270 ANDA203270 |
| Omeprazole | OMEPRAZOLE | Bryant Ranch Prepack | 40b4e1b6-f64d-44d5-bfc2-0cb8f78d9e67 | 2025-08-26 | Warnings, Adverse reactions | 203270 ANDA203270 |
| Omeprazole | OMEPRAZOLE | Bryant Ranch Prepack | 064b1418-0f42-4b18-9dee-cda40c5e1fca | 2024-12-11 | Warnings, Adverse reactions | 203270 ANDA203270 |
| Omeprazole | OMEPRAZOLE | Bryant Ranch Prepack | c311c1b9-8ec2-4ac0-baa2-a5063fba2d80 | 2024-12-11 | Warnings, Adverse reactions | 203270 ANDA203270 |
| Omeprazole | OMEPRAZOLE | Rising Pharma Holdings, Inc. | a1b1c61b-d4fe-433d-ad31-0b11758976fa | 2024-11-12 | Warnings, Adverse reactions | 203270 ANDA203270 57237-160 57237-161 57237-162 |
| Omeprazole | OMEPRAZOLE | A-S Medication Solutions | fe7d3352-d53f-4046-92ed-1eb5c917fbee | 2024-08-08 | Warnings, Adverse reactions | 203270 ANDA203270 |
| Omeprazole | OMEPRAZOLE | A-S Medication Solutions | 8d925ca6-83f1-4263-8218-4bf7cc8ceb39 | 2024-08-08 | Warnings, Adverse reactions | 203270 ANDA203270 |
| Omeprazole | OMEPRAZOLE | A-S Medication Solutions | 9378c870-f2cc-4a60-b0fd-08a4d43857bc | 2024-08-08 | Warnings, Adverse reactions | 203270 ANDA203270 |
| Omeprazole | OMEPRAZOLE | Aurobindo Pharma Limited | 934601b6-fbba-43c4-a8ef-7a7dfe9f9a51 | 2024-06-17 | Warnings, Adverse reactions | 203270 ANDA203270 59651-001 59651-002 59651-003 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-746 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-746 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-746 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-746 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-746 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-746 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-746 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-747 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-747 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-747 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-747 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-747 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-747 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-747 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-748 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-748 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-748 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-748 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-748 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-748 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-748 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 50090-3060 | Omeprazole | Omeprazole | A-S Medication Solutions | ANDA | Current |
| 50090-4209 | Omeprazole | Omeprazole | A-S Medication Solutions | ANDA | Current |
| 50090-4932 | Omeprazole | Omeprazole | A-S Medication Solutions | ANDA | Current |
| 50090-4932 | Omeprazole | Omeprazole | A-S Medication Solutions | ANDA | Current |
| 57237-160 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-160 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-160 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-160 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-160 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-160 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-160 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-160 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-160 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-161 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-161 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-161 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-161 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-161 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-161 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-161 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-161 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-161 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-162 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-162 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-162 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-162 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-162 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-162 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-162 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-162 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-162 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 59651-001 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-001 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-001 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-001 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-001 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-001 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-001 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-001 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-001 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-001 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-002 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-002 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-002 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-002 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-002 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-002 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-002 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-002 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-002 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-002 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-003 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-003 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-003 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-003 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-003 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-003 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-003 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-003 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |