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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2014-10-31 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2014-10-31 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2014-10-31 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2014-10-31 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A091672-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2014-10-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A091672-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2014-10-31 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091672-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | RS | 2014-10-31 | caaa826d4ba7… |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A091672-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A091672-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A091672-003 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A091672-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A091672-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A091672-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A091672-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091672-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A091672-003 | AB | 1 | caaa826d4ba7… |
| 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… |
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 | 2b7491dd-19f5-42e0-b901-7ba71a3820c7 | 2024-08-08 | Warnings, Adverse reactions | 091672 ANDA091672 71335-0299 |
| Omeprazole | OMEPRAZOLE | NuCarePharmaceuticals, Inc. | 4be616c4-1b9a-5654-e054-00144ff88e88 | 2024-07-17 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | NuCare Pharmaceuticals,Inc. | 6fa6afcf-33b3-3115-e053-2a91aa0abd0b | 2024-07-17 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | NuCare Pharmaceuticals,Inc. | 5564c9dc-6f99-6639-e054-00144ff8d46c | 2024-07-17 | Warnings, Adverse reactions | 091672 ANDA091672 |
| Omeprazole | OMEPRAZOLE | Proficient Rx LP | a53ea447-add5-4ed5-aa7e-975b13d90e75 | 2023-02-01 | Warnings, Adverse reactions | 091672 ANDA091672 71205-501 |
| Omeprazole | OMEPRAZOLE | Proficient Rx LP | 2d99b4fd-49b3-403d-96a4-0cceda85a95c | 2022-04-01 | Warnings, Adverse reactions | 091672 ANDA091672 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |