Application 206515
- Type
- ANDA
- Sponsor
- TORRENT
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 |
|---|---|---|---|---|---|---|---|
| A206515-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET / ORAL | 2017-05-03 | ||
| A206515-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET / ORAL | 2017-05-03 | ||
| A206515-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 25MG;40MG | TABLET / ORAL | 2017-05-03 |
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 | A206515-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-05-03 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A206515-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-05-03 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A206515-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-05-03 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206515-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-05-03 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206515-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-05-03 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206515-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-05-03 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206515-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-05-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206515-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-05-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206515-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-05-03 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206515-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-05-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206515-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-05-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206515-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-05-03 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206515-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-05-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206515-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-05-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A206515-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-05-03 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206515-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-05-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206515-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-05-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206515-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-05-03 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206515-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-05-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206515-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-05-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206515-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-05-03 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206515-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-05-03 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206515-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-05-03 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206515-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-05-03 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206515-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-05-03 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206515-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-05-03 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206515-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-05-03 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206515-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-05-03 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206515-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-05-03 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206515-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-05-03 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206515-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-05-03 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206515-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-05-03 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206515-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-05-03 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A206515-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-05-03 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A206515-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-05-03 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A206515-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-05-03 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206515-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-05-03 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206515-002 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;40MG | TABLET / ORAL | 2017-05-03 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206515-003 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 25MG;40MG | TABLET / ORAL | 2017-05-03 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206515-001 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2017-05-03 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206515-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206515-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206515-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A206515-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A206515-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A206515-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A206515-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A206515-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A206515-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A206515-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A206515-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A206515-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A206515-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A206515-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A206515-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A206515-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A206515-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A206515-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206515-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206515-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206515-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A206515-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A206515-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A206515-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A206515-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A206515-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A206515-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A206515-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A206515-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A206515-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A206515-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A206515-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A206515-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A206515-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A206515-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A206515-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A206515-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A206515-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A206515-003 | AB | 1 | ea99ee380514… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A206515-001 | AB | 1 | a67488948f0b… |
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 | Umedica Laboratories USA Inc. | 55d6aee1-01ca-4791-8404-386664b4ab07 | 2026-09-02 | Boxed warning, Warnings, Adverse reactions | Olmesartan Medoxomil and Hydrochlorothiazide |
| 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 | Ascend Laboratories, LLC | 798fee33-51ad-45d0-82f3-09289304139f | 2026-06-01 | 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 | REMEDYREPACK INC. | 9c68d45d-e4c8-4f6f-9ca5-faadc056e6e7 | 2026-02-27 | 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 | REMEDYREPACK INC. | 206cd386-cf38-4e0f-80ec-685aea41b048 | 2025-11-10 | 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 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 13668-251 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 20/12.5 | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-251 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 20/12.5 | TORRENT PHARMACEUTICALS LIMITED | ANDA | Current |
| 13668-251 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 20/12.5 | TORRENT PHARMACEUTICALS LIMITED | ANDA | Current |
| 13668-251 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 20/12.5 | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-251 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 20/12.5 | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-251 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 20/12.5 | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-251 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 20/12.5 | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-252 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 40/12.5 | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-252 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 40/12.5 | TORRENT PHARMACEUTICALS LIMITED | ANDA | Current |
| 13668-252 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 40/12.5 | TORRENT PHARMACEUTICALS LIMITED | ANDA | Current |
| 13668-252 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 40/12.5 | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-252 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 40/12.5 | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-252 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 40/12.5 | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-252 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 40/12.5 | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-253 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 40/25 | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-253 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 40/25 | TORRENT PHARMACEUTICALS LIMITED | ANDA | Current |
| 13668-253 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 40/25 | TORRENT PHARMACEUTICALS LIMITED | ANDA | Current |
| 13668-253 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 40/25 | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-253 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 40/25 | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-253 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 40/25 | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-253 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 40/25 | Torrent Pharmaceuticals Limited | ANDA | Current |
| 50090-5694 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 20/12.5 | A-S Medication Solutions | ANDA | Current |
| 50090-5694 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 20/12.5 | A-S Medication Solutions | ANDA | Current |
| 50090-5780 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 40/12.5 | A-S Medication Solutions | ANDA | Current |
| 70518-1344 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 20/12.5 | REMEDYREPACK INC. | ANDA | Current |
| 70518-1344 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 20/12.5 | REMEDYREPACK INC. | ANDA | Current |
| 70518-1344 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 20/12.5 | REMEDYREPACK INC. | ANDA | Current |
| 70518-1344 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 20/12.5 | REMEDYREPACK INC. | ANDA | Current |
| 70518-1344 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 20/12.5 | REMEDYREPACK INC. | ANDA | Current |
| 70518-2452 | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE 40/25 | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 48287 | ORIG | 2017-05-09 |