Application 091672
- Type
- ANDA
- Sponsor
- GLENMARK GENERICS
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 |
|---|---|---|---|---|---|---|---|
| A091672-001 | OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | |
| A091672-002 | OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2014-10-31 |
| A091672-003 | OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2014-10-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091672-001 | AB |
| A091672-002 | AB |
| A091672-003 | 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 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 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 | A091672-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091672-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091672-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091672-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091672-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091672-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091672-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091672-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091672-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091672-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091672-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091672-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091672-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091672-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091672-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091672-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091672-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091672-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091672-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091672-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091672-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091672-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091672-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091672-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091672-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091672-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091672-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091672-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091672-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091672-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091672-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091672-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091672-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091672-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091672-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091672-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091672-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091672-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091672-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091672-001 | 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 | REMEDYREPACK INC. | a19ce586-59b7-4c2e-9e8d-12e8f0f058e2 | 2026-07-21 | Warnings, Adverse reactions | 091672 ANDA091672 70518-2251 |
| Omeprazole | OMEPRAZOLE | HAWAII REPACK, INC. | 9359e826-5263-44fc-8dd3-9d0852fe42d6 | 2026-07-13 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | Bryant Ranch Prepack | dcaadc8c-32d1-476f-b821-973c012b7fa7 | 2026-07-10 | Warnings, Adverse reactions | 091672 ANDA091672 71335-1639 |
| Omeprazole | OMEPRAZOLE | Unit Dose Solutions, Inc. | 557d4c2c-5541-3a51-e063-6394a90ad278 | 2026-06-30 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | REMEDYREPACK INC. | d9b3918c-a66e-4277-8b8f-b7ece93fa7db | 2026-06-24 | Warnings, Adverse reactions | 091672 ANDA091672 70518-0199 |
| Omeprazole | OMEPRAZOLE | ST. MARY'S MEDICAL PARK PHARMACY | 4f5c91e6-6377-ca94-e063-6294a90a2f99 | 2026-04-13 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole DR | OMEPRAZOLE | Advanced Rx Pharmacy of Tennessee, LLC | c8bf92c9-1bab-7985-e053-2995a90a0225 | 2026-03-13 | Warnings, Adverse reactions | 091672 ANDA091672 80425-0169 |
| Omeprazole | OMEPRAZOLE | Glenmark Pharmaceuticals Inc., USA | c6c22be1-659d-4e71-b292-701e27da201b | 2026-01-19 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | Preferred Pharmaceuticals Inc. | fa0395a7-4353-4d64-9de8-d15857a7031c | 2026-01-13 | Warnings, Adverse reactions | 091672 ANDA091672 68788-6995 |
| Omeprazole | OMEPRAZOLE | A-S Medication Solutions | 17ccdbe0-19c1-498d-8e81-578be549b4e5 | 2025-12-02 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | Preferred Pharmaceuticals Inc. | aa8fc2ea-3942-453b-bc19-1e4b14ba6926 | 2025-09-03 | Warnings, Adverse reactions | 091672 ANDA091672 68788-6881 |
| Omeprazole | OMEPRAZOLE | Aphena Pharma Solutions - Tennessee, LLC | 3d6e07d1-38b1-f2ab-e063-6294a90a34ac | 2025-08-28 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | Aphena Pharma Solutions - Tennessee, LLC | bab55f83-ba03-49a0-842a-19c9976b7fe8 | 2025-08-28 | Warnings, Adverse reactions | 091672 ANDA091672 71610-280 |
| Omeprazole | OMEPRAZOLE | A-S Medication Solutions | 5bda70ae-c3f6-450b-892f-6814795dd6ca | 2025-08-18 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | PHOENIX RX LLC | 3a9baece-03be-6c77-e063-6394a90a7032 | 2025-07-23 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | Asclemed USA, Inc. | 9c41bcfa-b08b-3ac3-e053-2a95a90ae1c0 | 2025-02-13 | Warnings, Adverse reactions | 091672 ANDA091672 76420-055 |
| Omeprazole | OMEPRAZOLE | NCS HealthCare of KY, LLC dba Vangard Labs | d1e0c8fc-1f15-45a4-a80f-653a1dae5e56 | 2025-01-16 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole DR | OMEPRAZOLE | Advanced Rx of Tennessee, LLC | af85afda-6b0c-d657-e053-2a95a90afb4b | 2024-12-31 | Warnings, Adverse reactions | 091672 ANDA091672 80425-0070 |
| Omeprazole | OMEPRAZOLE | A-S Medication Solutions | 30e58465-c5d2-4925-85bb-53faa6135c5c | 2024-09-05 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | Proficient Rx LP | 5ad413ed-a21b-4f8b-9322-8fbb813b14d3 | 2024-09-01 | Warnings, Adverse reactions | 091672 ANDA091672 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68788-6881 | Omeprazole | Omeprazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6995 | Omeprazole | Omeprazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6995 | Omeprazole | Omeprazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6995 | Omeprazole | Omeprazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6995 | Omeprazole | Omeprazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6995 | Omeprazole | Omeprazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 69677-180 | Omeprazole | Omeprazole | Mas Management Group, Inc. | ANDA | Current |
| 70518-0199 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0199 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0199 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0199 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0199 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0199 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0199 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0199 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-0217 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-1362 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-1362 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-1362 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2251 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2251 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2251 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2251 | Omeprazole | Omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70934-014 | Omeprazole | Omeprazole | Denton Pharma, Inc. | ANDA | Current |
| 70934-014 | Omeprazole | Omeprazole | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-014 | Omeprazole | Omeprazole | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-015 | Omeprazole | Omeprazole | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-015 | Omeprazole | Omeprazole | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-015 | Omeprazole | Omeprazole | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-501 | Omeprazole | Omeprazole | Proficient Rx LP | ANDA | Current |
| 71205-501 | Omeprazole | Omeprazole | Proficient Rx LP | ANDA | Current |
| 71335-0299 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0299 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0299 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0299 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0299 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0490 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0490 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0490 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0490 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1191 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1191 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1191 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1191 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1627 | OMEPRAZOLE | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1639 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1639 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1639 | Omeprazole | Omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71610-280 | Omeprazole | Omeprazole | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 76420-055 | Omeprazole | Omeprazole | Asclemed USA, Inc. | ANDA | Current |
| 76420-055 | Omeprazole | Omeprazole | Asclemed USA, Inc. | ANDA | Current |
| 80425-0070 | Prilosec | Omeprazole 20mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0070 | Prilosec | Omeprazole 20mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0070 | Omeprazole | Omeprazole | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0070 | Omeprazole | Omeprazole | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0070 | Omeprazole | Omeprazole | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0169 | Prilosec | Omeprazole 40mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0169 | Omeprazole | Omeprazole | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0169 | Omeprazole | Omeprazole | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0169 | Omeprazole | Omeprazole | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |