Application 075410
- Type
- ANDA
- Sponsor
- LANNETT CO INC
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 |
|---|---|---|---|---|---|---|---|
| A075410-001 | OMEPRAZOLE | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | |
| A075410-002 | OMEPRAZOLE | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | |
| A075410-003 | OMEPRAZOLE | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075410-001 | AB |
| A075410-002 | AB |
| A075410-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075410-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075410-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075410-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-23 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A075410-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075410-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075410-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075410-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075410-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075410-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075410-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075410-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075410-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075410-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075410-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075410-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075410-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075410-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075410-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075410-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075410-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075410-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075410-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075410-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075410-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075410-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075410-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075410-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075410-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075410-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075410-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075410-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075410-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075410-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075410-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075410-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075410-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075410-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075410-002 | OMEPRAZOLE | 20MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075410-003 | OMEPRAZOLE | 40MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2009-01-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075410-001 | OMEPRAZOLE | 10MG | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2002-11-01 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075410-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075410-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075410-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A075410-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075410-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075410-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075410-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075410-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075410-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075410-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075410-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075410-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075410-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075410-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075410-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075410-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075410-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075410-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075410-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075410-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075410-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075410-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075410-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075410-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075410-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075410-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075410-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075410-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075410-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075410-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075410-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075410-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075410-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075410-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075410-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075410-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075410-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075410-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075410-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075410-001 | AB | 1 | 301d65b070ca… |
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 | Chartwell RX, LLC | 10f5502a-2e63-4f2a-a3ba-ddc5bd403051 | 2025-12-22 | Warnings, Adverse reactions | 075410 ANDA075410 |
| Omeprazole | OMEPRAZOLE | PD-Rx Pharmaceuticals, Inc. | ed9895ae-3d18-434c-8b56-47bccdc8fe6d | 2025-10-08 | Warnings, Adverse reactions | 075410 ANDA075410 72789-155 |
| Omeprazole | OMEPRAZOLE | NuCare Pharmaceuticals,Inc. | ad675ef6-5377-b9f2-e053-2995a90a06e9 | 2024-07-17 | Warnings, Adverse reactions | 075410 ANDA075410 |
| Omeprazole | OMEPRAZOLE | NuCare Pharmaceuticals,Inc. | 55a1fb3c-f040-2e39-e054-00144ff8d46c | 2024-07-17 | Warnings, Adverse reactions | 075410 ANDA075410 |
| Omeprazole | OMEPRAZOLE | NuCare Pharmaceuticals,Inc. | 8991d464-7abc-4350-e053-2995a90a4ea7 | 2024-06-14 | Warnings, Adverse reactions | 075410 ANDA075410 68071-4906 |
| Omeprazole | OMEPRAZOLE | Bryant Ranch Prepack | 1318a1c1-222d-471a-92d6-3632c82fb999 | 2024-05-24 | Warnings, Adverse reactions | 075410 ANDA075410 71335-1532 |
| Omeprazole | OMEPRAZOLE | Bryant Ranch Prepack | 18f5a7cc-40d8-4aeb-a601-47bc9024f130 | 2024-05-23 | Warnings, Adverse reactions | 075410 ANDA075410 71335-1746 |
| Omeprazole | OMEPRAZOLE | Lannett Company, Inc. | 92201fb1-4570-42db-8da3-3b8c0e291d32 | 2023-04-21 | Warnings, Adverse reactions | 075410 ANDA075410 |
| Omeprazole | OMEPRAZOLE | Proficient Rx LP | 9786b04f-f827-460b-91bc-c0ac967f95dd | 2022-11-01 | Warnings, Adverse reactions | 075410 ANDA075410 71205-157 |
| Omeprazole | OMEPRAZOLE | Aphena Pharma Solutions - Tennessee, LLC | 4b188d97-f1b3-468d-9818-b8333bf24b5a | 2020-12-17 | Warnings, Adverse reactions | 075410 ANDA075410 |
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 |
|---|---|---|---|---|---|
| 68071-4140 | Omeprazole | omeprazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4140 | Omeprazole | omeprazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4146 | Omeprazole | omeprazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4906 | Omeprazole | omeprazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4906 | Omeprazole | omeprazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4930 | Omeprazole | omeprazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4930 | Omeprazole | omeprazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5044 | Omeprazole | omeprazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5044 | Omeprazole | omeprazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7626 | Omeprazole | omeprazole | Preferred Pharmaeuticals Inc. | ANDA | Current |
| 68788-7626 | Omeprazole | omeprazole | Preferred Pharmaeuticals Inc. | ANDA | Current |
| 68788-7804 | Omeprazole | omeprazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7804 | Omeprazole | omeprazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-2235 | Omeprazole | omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2235 | Omeprazole | omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2235 | Omeprazole | omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2235 | Omeprazole | omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2235 | Omeprazole | omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2791 | Omeprazole | omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2791 | Omeprazole | omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2791 | Omeprazole | omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70518-2791 | Omeprazole | omeprazole | REMEDYREPACK INC. | ANDA | Current |
| 70934-479 | Omeprazole | omeprazole | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-486 | Omeprazole | omeprazole | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-157 | Omeprazole | omeprazole | Proficient Rx LP | ANDA | Current |
| 71205-157 | Omeprazole | omeprazole | Proficient Rx LP | ANDA | Current |
| 71205-157 | Omeprazole | omeprazole | Proficient Rx LP | ANDA | Current |
| 71205-157 | Omeprazole | omeprazole | Proficient Rx LP | ANDA | Current |
| 71335-1532 | Omeprazole | omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1532 | Omeprazole | omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1532 | Omeprazole | omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1746 | Omeprazole | omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-1746 | Omeprazole | omeprazole | Bryant Ranch Prepack | ANDA | Current |
| 71610-407 | Omeprazole | omeprazole | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-407 | Omeprazole | omeprazole | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-407 | Omeprazole | omeprazole | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-408 | Omeprazole | omeprazole | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-408 | Omeprazole | omeprazole | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-408 | Omeprazole | omeprazole | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 72789-155 | Omeprazole | omeprazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-155 | Omeprazole | omeprazole | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |