Application 200532
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | TABLET;ORAL | 12.5MG;20MG | No | No |
| 002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | TABLET;ORAL | 12.5MG;40MG | No | No |
| 003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | TABLET;ORAL | 25MG;40MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A200532-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET / ORAL | 2017-04-24 | ||
| A200532-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET / ORAL | 2017-04-24 | ||
| A200532-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 25MG;40MG | TABLET / ORAL | 2017-04-24 |
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 | A200532-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-04-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A200532-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-04-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A200532-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-04-24 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A200532-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-04-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A200532-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-04-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A200532-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-04-24 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200532-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-04-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200532-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-04-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A200532-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-04-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200532-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-04-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200532-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-04-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A200532-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-04-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200532-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-04-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200532-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-04-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A200532-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-04-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200532-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-04-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200532-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-04-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A200532-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-04-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200532-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-04-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200532-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-04-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A200532-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-04-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200532-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-04-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200532-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-04-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A200532-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-04-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200532-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-04-24 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200532-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-04-24 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A200532-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-04-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200532-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-04-24 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200532-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-04-24 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A200532-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-04-24 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200532-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-04-24 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200532-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-04-24 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A200532-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-04-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A200532-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-04-24 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A200532-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-04-24 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A200532-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-04-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200532-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-04-24 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200532-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-04-24 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A200532-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-04-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A200532-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-04-24 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-05-31 18:47 UTC | 2024-05 | A200532-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A200532-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A200532-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A200532-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A200532-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A200532-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A200532-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A200532-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A200532-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A200532-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A200532-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A200532-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A200532-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A200532-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A200532-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A200532-003 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A200532-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A200532-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A200532-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A200532-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A200532-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A200532-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A200532-002 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A200532-002 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A200532-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A200532-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A200532-002 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A200532-002 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A200532-002 | AB | 1 | cb3db0bc1861… |
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 | Golden State Medical Supply, Inc. | 574d2679-c036-fa12-e063-6394a90aef33 | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | ScieGen Pharmaceuticals Inc | 52332190-2a12-d205-e063-6394a90ab7c5 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE |
| Olmesartan Medoxomil and Hydrochlorothiazide | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 77e71a2e-8370-4f7a-a5e4-93d86bd37dad | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | Olmesartan Medoxomil and Hydrochlorothiazide |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 68d44330-4213-46a7-97b9-f858c16454d1 | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 78eb9041-a738-4056-8705-8c1dd13a4da4 | 2026-05-12 | Boxed warning, Warnings, Adverse reactions | OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 2c8bb018-af07-4745-a4e9-f9a6795a5ea2 | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | bb362b67-4a14-4491-9e12-0f7d5c7a65bc | 2026-02-05 | Boxed warning, Warnings, Adverse reactions | OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | de2d4628-08b3-4e31-aacc-ed85897f52e3 | 2026-02-05 | Boxed warning, Warnings, Adverse reactions | OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 89f525cb-fa15-4407-8cbf-14e7f6bf9055 | 2026-02-05 | Boxed warning, Warnings, Adverse reactions | OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE |
| Olmesartan Medoxomil and Hydrochlorothiazide | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | REMEDYREPACK INC. | de815d64-b8d4-46a8-95b8-c230abe7f767 | 2026-02-03 | Boxed warning, Warnings, Adverse reactions | Olmesartan Medoxomil and Hydrochlorothiazide |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Solco Healthcare US, LLC | bdca31d3-60b1-4659-aef7-56530b4f9039 | 2025-12-31 | Boxed warning, Warnings, Adverse reactions | OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE |
| Olmesartan Medoxomil and Hydrochlorothiazide | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Lifestar Pharma LLC | 9771066e-c05d-6a93-e053-2995a90a7e87 | 2025-12-09 | Boxed warning, Warnings, Adverse reactions | Olmesartan Medoxomil and Hydrochlorothiazide |
| OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Accord Healthcare Inc. | d858a6de-dda5-4bcd-a255-5723d01d896f | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE |
| Olmesartan medoxomil and hydrochlorothiazide | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Camber Pharmaceuticals, Inc. | d421f352-9500-4d3e-8bc3-0cdcc2050514 | 2025-08-26 | Boxed warning, Warnings, Adverse reactions | Olmesartan medoxomil and hydrochlorothiazide |
| Olmesartan Medoxomil and Hydrochlorothiazide | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 0360db3a-17cf-4d24-97ba-e0a6fcc94351 | 2025-07-14 | Boxed warning, Warnings, Adverse reactions | Olmesartan Medoxomil and Hydrochlorothiazide |
| Olmesartan Medoxomil and Hydrochlorothiazide | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Alembic Pharmaceuticals Inc. | ca1a0aac-d81d-4c0a-91ea-cb719af772bf | 2025-06-25 | Boxed warning, Warnings, Adverse reactions | Olmesartan Medoxomil and Hydrochlorothiazide |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 5c4c5907-36f0-461e-b0c9-d51edff32a97 | 2025-06-19 | Boxed warning, Warnings, Adverse reactions | OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE |
| 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 | OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE |
| Olmesartan Medoxomil and Hydrochlorothiazide | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Aurobindo Pharma Limited | 744c1785-42b2-46a5-b0f4-2887a9ec2051 | 2025-06-03 | Boxed warning, Warnings, Adverse reactions | Olmesartan Medoxomil and Hydrochlorothiazide |
| OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | Macleods Pharmaceuticals Limited | 03ff0f7e-6aa1-4c38-8c9a-5f1c6a56c747 | 2025-05-22 | Boxed warning, Warnings, Adverse reactions | OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE |
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 |
|---|---|---|---|---|---|
| 0093-7615 | Olmesartan Medoxomil and Hydrochlorothiazide | Olmesartan Medoxomil and Hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7615 | Olmesartan Medoxomil and Hydrochlorothiazide | Olmesartan Medoxomil and Hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7616 | Olmesartan Medoxomil and Hydrochlorothiazide | Olmesartan Medoxomil and Hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7616 | Olmesartan Medoxomil and Hydrochlorothiazide | Olmesartan Medoxomil and Hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7617 | Olmesartan Medoxomil and Hydrochlorothiazide | Olmesartan Medoxomil and Hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7617 | Olmesartan Medoxomil and Hydrochlorothiazide | Olmesartan Medoxomil and Hydrochlorothiazide | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 50090-3053 | Olmesartan Medoxomil and Hydrochlorothiazide | Olmesartan Medoxomil and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-3348 | Olmesartan Medoxomil and Hydrochlorothiazide | Olmesartan Medoxomil and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 63629-7278 | Olmesartan Medoxomil and Hydrochlorothiazide | Olmesartan Medoxomil and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
| 63629-7278 | Olmesartan Medoxomil and Hydrochlorothiazide | Olmesartan Medoxomil and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |