Application 076048
- Type
- ANDA
- Sponsor
- APOTEX
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 |
|---|---|---|---|---|---|---|---|
| A076048-001 | OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | |
| A076048-002 | OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | |
| A076048-003 | OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076048-001 | AB |
| A076048-002 | AB |
| A076048-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076048-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076048-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076048-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076048-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076048-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076048-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076048-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076048-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076048-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076048-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076048-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076048-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076048-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076048-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076048-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2007-10-22 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076048-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076048-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076048-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076048-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076048-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076048-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076048-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076048-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076048-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076048-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076048-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076048-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076048-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076048-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076048-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076048-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076048-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076048-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076048-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076048-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076048-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076048-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076048-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076048-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076048-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076048-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076048-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076048-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076048-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076048-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076048-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076048-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076048-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076048-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076048-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076048-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076048-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076048-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076048-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076048-001 | AB | 1 | 8072bd15b7f6… |
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 | Bryant Ranch Prepack | 1249c42d-6358-48b3-8fe0-10333c7f501d | 2024-10-31 | Warnings, Adverse reactions | 076048 ANDA076048 |
| Omeprazole | OMEPRAZOLE | Bryant Ranch Prepack | 44349466-73ea-4053-8ff6-5b4b7372c9cd | 2024-10-03 | Warnings, Adverse reactions | 076048 ANDA076048 |
| Omeprazole | OMEPRAZOLE | Proficient Rx LP | 03ac077f-3873-4087-96d0-89049161dea9 | 2024-10-01 | Warnings, Adverse reactions | 076048 ANDA076048 63187-070 63187-061 |
| Omeprazole | OMEPRAZOLE | Proficient Rx LP | 253451a6-02a9-4b27-aed7-f3dbc2e09682 | 2024-10-01 | Warnings, Adverse reactions | 076048 ANDA076048 |
| Omeprazole | OMEPRAZOLE | Apotex Corp | b83329ac-a65e-b3af-a3fb-c5a6c740e5e7 | 2024-04-22 | Warnings, Adverse reactions | 076048 ANDA076048 60505-0065 60505-0146 60505-0145 60505-3952 |
| Omeprazole | OMEPRAZOLE | Aphena Pharma Solutions - Tennessee, LLC | a0dc4ffa-db18-4871-9d36-51d02e3b2bd9 | 2019-03-20 | Warnings, Adverse reactions | 076048 ANDA076048 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-5684 | Omeprazole | Omeprazole | Major Pharmaceuticals | ANDA | Current |
| 0904-5684 | Omeprazole | Omeprazole | Major Pharmaceuticals | ANDA | Current |
| 10544-878 | Omeprazole | Omeprazole | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-895 | Omeprazole | Omeprazole | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-898 | Omeprazole | Omeprazole | Blenheim Pharmacal, Inc. | ANDA | Current |
| 33358-273 | Omeprazole | Omeprazole | RxChange Co. | ANDA | Current |
| 42291-572 | Omeprazole | Omeprazole | AvKARE, Inc. | ANDA | Current |
| 42291-572 | Omeprazole | Omeprazole | AvKARE | ANDA | Current |
| 42291-573 | Omeprazole | Omeprazole | AvKARE, Inc. | ANDA | Current |
| 42291-573 | Omeprazole | Omeprazole | AvKARE | ANDA | Current |
| 42708-080 | Omeprazole | Omeprazole | QPharma Inc | ANDA | Current |
| 42708-080 | Omeprazole | Omeprazole | QPharma Inc | ANDA | Current |
| 42708-080 | Omeprazole | Omeprazole | QPharma Inc | ANDA | Current |
| 43063-212 | Omeprazole | Omeprazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-212 | Omeprazole | Omeprazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-212 | Omeprazole | Omeprazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-451 | Omeprazole | Omeprazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-451 | Omeprazole | Omeprazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-451 | Omeprazole | Omeprazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 48433-327 | Omeprazole | Omeprazole | Safecor Health, LLC | ANDA | Current |
| 50436-0065 | Omeprazole | Omeprazole | Unit Dose Services | ANDA | Current |
| 50436-0146 | Omeprazole | Omeprazole | Unit Dose Services | ANDA | Current |
| 50436-3127 | Omeprazole | Omeprazole | Unit Dose Services | ANDA | Current |
| 51655-022 | OMEPRAZOLE | OMEPRAZOLE DR | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 51655-023 | OMEPRAZOLE | OMEPRAZOLE | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 53808-0745 | Omeprazole Delayed-Release | OMEPRAZOLE | DOH CENTRAL PHARMACY | ANDA | Current |
| 55154-3348 | Omeprazole | Omeprazole | Cardinal Health | ANDA | Current |
| 55154-3348 | Omeprazole | Omeprazole | Cardinal Health | ANDA | Current |
| 58517-020 | Omeprazole | Omeprazole | New Horizon Rx Group, LLC | ANDA | Current |
| 60429-182 | Omeprazole | Omeprazole | Golden State Medical Supply, Inc. | ANDA | Current |
| 60505-0065 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0065 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0065 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0065 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0065 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0065 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0065 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0065 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0065 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0145 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0145 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0145 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0145 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0145 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0145 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0145 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0145 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0145 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0146 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0146 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0146 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0146 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0146 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0146 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0146 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0146 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-0146 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-3952 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-3952 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-3952 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-3952 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-3952 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-3952 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-3952 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-3952 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60505-3952 | Omeprazole | Omeprazole | Apotex Corp | ANDA | Current |
| 60760-521 | Omeprazole | Omeprazole | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-176 | OMEPRAZOLE DR | OMEPRAZOLE DR | Direct Rx | ANDA | Current |
| 61919-176 | OMEPRAZOLE DR | OMEPRAZOLE DR | Direct Rx | ANDA | Current |
| 61919-176 | OMEPRAZOLE DR | OMEPRAZOLE DR | Direct Rx | ANDA | Current |
| 61919-176 | OMEPRAZOLE DR | OMEPRAZOLE DR | Direct Rx | ANDA | Current |
| 61919-773 | OMEPRAZOLE DR | OMEPRAZOLE DR | Direct Rx | ANDA | Current |
| 61919-773 | OMEPRAZOLE DR | OMEPRAZOLE DR | Direct Rx | ANDA | Current |
| 61919-773 | OMEPRAZOLE DR | OMEPRAZOLE DR | Direct Rx | ANDA | Current |
| 61919-773 | OMEPRAZOLE DR | OMEPRAZOLE DR | Direct Rx | ANDA | Current |
| 63187-061 | Omeprazole | Omeprazole | Proficient Rx LP | ANDA | Current |
| 63187-061 | Omeprazole | Omeprazole | Proficient Rx LP | ANDA | Current |
| 63187-061 | Omeprazole | Omeprazole | Proficient Rx LP | ANDA | Current |
| 63187-070 | Omeprazole | Omeprazole | Proficient Rx LP | ANDA | Current |
| 63187-070 | Omeprazole | Omeprazole | Proficient Rx LP | ANDA | Current |