Application 204801
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | TABLET;ORAL | 20MG;12.5MG | No | No |
| 002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | TABLET;ORAL | 40MG;12.5MG | No | No |
| 003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | TABLET;ORAL | 40MG;25MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204801-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET / ORAL | AB | 2023-06-01 | |
| A204801-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET / ORAL | AB | 2023-06-01 | |
| A204801-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 25MG;40MG | TABLET / ORAL | AB | 2023-06-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204801-001 | AB |
| A204801-002 | AB |
| A204801-003 | 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 | A204801-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2023-06-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204801-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2023-06-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204801-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2023-06-01 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A204801-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2023-06-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204801-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2023-06-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204801-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2023-06-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204801-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2023-06-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204801-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2023-06-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204801-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2023-06-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204801-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2023-06-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204801-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2023-06-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204801-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2023-06-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204801-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2023-06-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204801-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2023-06-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204801-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2023-06-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204801-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2023-06-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204801-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2023-06-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204801-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2023-06-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204801-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2023-06-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204801-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2023-06-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204801-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2023-06-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204801-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2023-06-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204801-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2023-06-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204801-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2023-06-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204801-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2023-06-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204801-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2023-06-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204801-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2023-06-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204801-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2023-06-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204801-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2023-06-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204801-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2023-06-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204801-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2023-06-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204801-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2023-06-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204801-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2023-06-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204801-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2023-06-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204801-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2023-06-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204801-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2023-06-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204801-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2023-06-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204801-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | AB | 2023-06-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204801-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | AB | 2023-06-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204801-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2023-06-01 | 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 | A204801-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204801-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204801-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A204801-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204801-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204801-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204801-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204801-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204801-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204801-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204801-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204801-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204801-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204801-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204801-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204801-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204801-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204801-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204801-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204801-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204801-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204801-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204801-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204801-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204801-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204801-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204801-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204801-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204801-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204801-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204801-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204801-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204801-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A204801-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204801-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204801-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204801-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204801-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204801-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204801-001 | 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 |
|---|---|---|---|---|---|---|
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | bb362b67-4a14-4491-9e12-0f7d5c7a65bc | 2026-02-05 | Boxed warning, Warnings, Adverse reactions | 204801 ANDA204801 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | de2d4628-08b3-4e31-aacc-ed85897f52e3 | 2026-02-05 | Boxed warning, Warnings, Adverse reactions | 204801 ANDA204801 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 89f525cb-fa15-4407-8cbf-14e7f6bf9055 | 2026-02-05 | Boxed warning, Warnings, Adverse reactions | 204801 ANDA204801 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | f7415f1d-98c7-454f-bb1a-f59e95652c88 | 2025-06-10 | Boxed warning, Warnings, Adverse reactions | 204801 ANDA204801 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Macleods Pharmaceuticals Limited | 03ff0f7e-6aa1-4c38-8c9a-5f1c6a56c747 | 2025-05-22 | Boxed warning, Warnings, Adverse reactions | 204801 ANDA204801 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | NorthStar RxLLC | 364af4fe-cde8-466f-b56f-d93d532b56f5 | 2025-04-10 | Boxed warning, Warnings, Adverse reactions | 204801 ANDA204801 |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 4a2c2b8f-1479-4555-9ba8-ca4407003296 | 2024-12-27 | Boxed warning, Warnings, Adverse reactions | 204801 ANDA204801 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.