Application 091154
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | TABLET;ORAL | EQ 5MG BASE;20MG | No | No |
| 002 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | TABLET;ORAL | EQ 5MG BASE;40MG | No | No |
| 003 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | TABLET;ORAL | EQ 10MG BASE;20MG | No | No |
| 004 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | TABLET;ORAL | EQ 10MG BASE;40MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091154-001 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET / ORAL | 2016-10-26 | ||
| A091154-002 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET / ORAL | 2016-10-26 | ||
| A091154-003 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET / ORAL | 2016-10-26 | ||
| A091154-004 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET / ORAL | 2016-10-26 |
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 | A091154-001 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET / ORAL | 2016-10-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091154-002 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET / ORAL | 2016-10-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091154-003 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET / ORAL | 2016-10-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A091154-004 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET / ORAL | 2016-10-26 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091154-001 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET / ORAL | 2016-10-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091154-002 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET / ORAL | 2016-10-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091154-003 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET / ORAL | 2016-10-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091154-004 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET / ORAL | 2016-10-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091154-001 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET / ORAL | 2016-10-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091154-002 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET / ORAL | 2016-10-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091154-003 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET / ORAL | 2016-10-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091154-004 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET / ORAL | 2016-10-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091154-001 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET / ORAL | 2016-10-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091154-002 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET / ORAL | 2016-10-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091154-003 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET / ORAL | 2016-10-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091154-004 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET / ORAL | 2016-10-26 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091154-001 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET / ORAL | 2016-10-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091154-002 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET / ORAL | 2016-10-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091154-003 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET / ORAL | 2016-10-26 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091154-004 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET / ORAL | 2016-10-26 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091154-001 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET / ORAL | 2016-10-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091154-002 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET / ORAL | 2016-10-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091154-003 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET / ORAL | 2016-10-26 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091154-004 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET / ORAL | 2016-10-26 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091154-001 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET / ORAL | 2016-10-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091154-002 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET / ORAL | 2016-10-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091154-003 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET / ORAL | 2016-10-26 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091154-004 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET / ORAL | 2016-10-26 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091154-001 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET / ORAL | 2016-10-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091154-002 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET / ORAL | 2016-10-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091154-003 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET / ORAL | 2016-10-26 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091154-004 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET / ORAL | 2016-10-26 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091154-001 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET / ORAL | 2016-10-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091154-002 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET / ORAL | 2016-10-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091154-003 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET / ORAL | 2016-10-26 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091154-004 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET / ORAL | 2016-10-26 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091154-001 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 5MG BASE;20MG | TABLET / ORAL | 2016-10-26 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091154-002 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 5MG BASE;40MG | TABLET / ORAL | 2016-10-26 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091154-003 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 10MG BASE;20MG | TABLET / ORAL | 2016-10-26 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091154-004 | AMLODIPINE AND OLMESARTAN MEDOXOMIL | EQ 10MG BASE;40MG | TABLET / ORAL | 2016-10-26 | d8e5a09893c0… |
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 |
|---|---|---|---|---|---|---|
| Amlodipine and Olmesartan Medoxomil | AMLODIPINE AND OLMESARTAN MEDOXOMIL | A-S Medication Solutions | 350c7317-a92d-4bcb-973f-19d6de87ed83 | 2026-01-24 | Boxed warning, Warnings, Adverse reactions | Amlodipine and Olmesartan Medoxomil |
| Amlodipine and Olmesartan Medoxomil | AMLODIPINE AND OLMESARTAN MEDOXOMIL | AvKARE | 1b30c3fe-5c84-0d42-e063-6394a90a81d8 | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | Amlodipine and Olmesartan Medoxomil |
| AMLODIPINE and OLMESARTAN medoxomil | AMLODIPINE AND OLMESARTAN MEDOXOMIL | Macleods Pharmaceuticals Limited | c86a3c45-c906-46c9-9f7b-6c3d89bbe48f | 2026-01-03 | Boxed warning, Warnings, Adverse reactions | AMLODIPINE and OLMESARTAN medoxomil |
| Amlodipine and olmesartan Medoxomil | AMLODIPINE AND OLMESARTAN MEDOXOMIL | Ascend Laboratories, LLC | c1204fbe-d086-43cf-bbaa-efec9cd0487c | 2025-05-30 | Boxed warning, Warnings, Adverse reactions | Amlodipine and olmesartan Medoxomil |
| Amlodipine and Olmesartan Medoxomil | AMLODIPINE AND OLMESARTAN MEDOXOMIL | Camber Pharmaceuticals, Inc. | 99865c67-5475-4e60-98d5-a8fa850fe9ba | 2025-03-26 | Boxed warning, Warnings, Adverse reactions | Amlodipine and Olmesartan Medoxomil |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE AND OLMESARTAN MEDOXOMIL | Micro Labs Limited | 7fcf6a87-7b3e-4cef-8c47-c8a008cfea82 | 2025-01-09 | Boxed warning, Warnings, Adverse reactions | AMLODIPINE AND OLMESARTAN MEDOXOMIL |
| AMLODIPINE AND OLMESARTAN MEDOXOMIL | AMLODIPINE AND OLMESARTAN MEDOXOMIL | Bryant Ranch Prepack | f16c4254-fb35-408e-9419-e17d684ea5ac | 2024-08-15 | Boxed warning, Warnings, Adverse reactions | AMLODIPINE AND OLMESARTAN MEDOXOMIL |
| Amlodipine and Olmesartan Medoxomil | AMLODIPINE AND OLMESARTAN MEDOXOMIL | ScieGen Pharmaceuticals, Inc | c531fceb-09aa-492b-a5a3-2b004e9eadda | 2024-04-18 | Boxed warning, Warnings, Adverse reactions | Amlodipine and Olmesartan Medoxomil |
| Amlodipine and Olmesartan Medoxomil | AMLODIPINE AND OLMESARTAN MEDOXOMIL | Aurobindo Pharma Limited | b13a8b46-104e-4b75-8f4a-928d2204eff5 | 2024-04-15 | Boxed warning, Warnings, Adverse reactions | Amlodipine and Olmesartan Medoxomil |
| Amlodipine and Olmesartan Medoxomil | AMLODIPINE AND OLMESARTAN MEDOXOMIL | Amneal Pharmaceuticals NY LLC | 02f9b562-6f7f-4783-bb0d-67c318073e1c | 2024-03-26 | Boxed warning, Warnings, Adverse reactions | Amlodipine and Olmesartan Medoxomil |
| Amlodipine and Olmesartan Medoxomil | AMLODIPINE AND OLMESARTAN MEDOXOMIL | Glenmark Pharmaceuticals Inc., USA | 2edf43fb-0755-4ffb-bc38-75a4e2432588 | 2021-02-28 | Boxed warning, Warnings, Adverse reactions | Amlodipine and Olmesartan Medoxomil |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-7027 | Amlodipine and Olmesartan Medoxomil | Amlodipine and Olmesartan Medoxomil | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7027 | Amlodipine and Olmesartan Medoxomil | Amlodipine and Olmesartan Medoxomil | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7028 | Amlodipine and Olmesartan Medoxomil | Amlodipine and Olmesartan Medoxomil | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7028 | Amlodipine and Olmesartan Medoxomil | Amlodipine and Olmesartan Medoxomil | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7029 | Amlodipine and Olmesartan Medoxomil | Amlodipine and Olmesartan Medoxomil | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7029 | Amlodipine and Olmesartan Medoxomil | Amlodipine and Olmesartan Medoxomil | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7030 | Amlodipine and Olmesartan Medoxomil | Amlodipine and Olmesartan Medoxomil | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7030 | Amlodipine and Olmesartan Medoxomil | Amlodipine and Olmesartan Medoxomil | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 45865-901 | Amlodipine and Olmesartan Medoxomil | Amlodipine and Olmesartan Medoxomil | medsource pharmaceuticals | ANDA | Current |