Application 203580
- Type
- ANDA
- Sponsor
- TORRENT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | TABLET;ORAL | EQ 5MG BASE;12.5MG;20MG | No | No |
| 002 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | TABLET;ORAL | EQ 5MG BASE;12.5MG;40MG | No | No |
| 003 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | TABLET;ORAL | EQ 5MG BASE;25MG;40MG | No | No |
| 004 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | TABLET;ORAL | EQ 10MG BASE;12.5MG;40MG | No | No |
| 005 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | TABLET;ORAL | EQ 10MG BASE;25MG;40MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203580-001 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;20MG | TABLET / ORAL | AB | 2016-10-26 | |
| A203580-002 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2016-10-26 | |
| A203580-003 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;25MG;40MG | TABLET / ORAL | AB | 2016-10-26 | |
| A203580-004 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2016-10-26 | |
| A203580-005 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;25MG;40MG | TABLET / ORAL | AB | 2016-10-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203580-001 | AB |
| A203580-002 | AB |
| A203580-003 | AB |
| A203580-004 | AB |
| A203580-005 | 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 | A203580-001 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;20MG | TABLET / ORAL | AB | 2016-10-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203580-002 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2016-10-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203580-003 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;25MG;40MG | TABLET / ORAL | AB | 2016-10-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203580-004 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2016-10-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203580-005 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;25MG;40MG | TABLET / ORAL | AB | 2016-10-26 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A203580-001 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;20MG | TABLET / ORAL | 2016-10-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A203580-002 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2016-10-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203580-003 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;25MG;40MG | TABLET / ORAL | AB | 2016-10-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203580-004 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;12.5MG;40MG | TABLET / ORAL | 2016-10-26 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A203580-005 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;25MG;40MG | TABLET / ORAL | 2016-10-26 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203580-001 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;20MG | TABLET / ORAL | 2016-10-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203580-002 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2016-10-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203580-003 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;25MG;40MG | TABLET / ORAL | AB | 2016-10-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203580-004 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;12.5MG;40MG | TABLET / ORAL | 2016-10-26 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A203580-005 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;25MG;40MG | TABLET / ORAL | 2016-10-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203580-001 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;20MG | TABLET / ORAL | 2016-10-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203580-002 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2016-10-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203580-003 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;25MG;40MG | TABLET / ORAL | AB | 2016-10-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203580-004 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;12.5MG;40MG | TABLET / ORAL | 2016-10-26 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203580-005 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;25MG;40MG | TABLET / ORAL | 2016-10-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203580-001 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;20MG | TABLET / ORAL | 2016-10-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203580-002 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2016-10-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203580-003 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;25MG;40MG | TABLET / ORAL | AB | 2016-10-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203580-004 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;12.5MG;40MG | TABLET / ORAL | 2016-10-26 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A203580-005 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;25MG;40MG | TABLET / ORAL | 2016-10-26 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203580-001 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;20MG | TABLET / ORAL | AB | 2016-10-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203580-002 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2016-10-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203580-003 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;25MG;40MG | TABLET / ORAL | AB | 2016-10-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203580-004 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2016-10-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203580-005 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;25MG;40MG | TABLET / ORAL | AB | 2016-10-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203580-001 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;20MG | TABLET / ORAL | AB | 2016-10-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203580-002 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2016-10-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203580-003 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;25MG;40MG | TABLET / ORAL | AB | 2016-10-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203580-004 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2016-10-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203580-005 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;25MG;40MG | TABLET / ORAL | AB | 2016-10-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203580-001 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;20MG | TABLET / ORAL | AB | 2016-10-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203580-002 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2016-10-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203580-003 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;25MG;40MG | TABLET / ORAL | AB | 2016-10-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203580-004 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2016-10-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203580-005 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;25MG;40MG | TABLET / ORAL | AB | 2016-10-26 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A203580-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203580-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203580-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203580-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203580-005 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A203580-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203580-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A203580-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203580-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203580-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203580-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203580-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203580-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203580-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203580-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203580-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203580-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203580-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203580-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203580-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203580-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203580-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203580-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203580-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203580-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203580-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203580-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203580-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203580-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203580-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203580-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203580-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203580-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203580-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203580-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203580-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203580-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203580-005 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203580-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203580-002 | AB | 1 | 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 |
|---|---|---|---|---|---|---|
| Olmesartan medoxomil, amlodipine and hydrochlorothiazide | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | Camber Pharmaceuticals, Inc. | 45e975ff-07b1-411a-96ee-a011d1619b1e | 2026-01-05 | Boxed warning, Warnings, Adverse reactions | Olmesartan medoxomil, amlodipine and hydrochlorothiazide |
| OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE | OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE | Micro Labs Limited | 9fb71df8-f70f-47dc-9465-8d8748261caf | 2025-11-29 | Boxed warning, Warnings, Adverse reactions | OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE |
| Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | Teva Pharmaceuticals USA, Inc. | 5c128ef2-60a6-40f3-b37f-ee139fe27987 | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 13668-382 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/10/25 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/10/25 mg | TORRENT PHARMACEUTICALS LIMITED | ANDA | Current |
| 13668-382 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/10/25 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/10/25 mg | TORRENT PHARMACEUTICALS LIMITED | ANDA | Current |
| 13668-382 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/10/25 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/10/25 mg | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-382 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/10/25 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/10/25 mg | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-382 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/10/25 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/10/25 mg | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-383 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/10/12.5 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/10/12.5 mg | TORRENT PHARMACEUTICALS LIMITED | ANDA | Current |
| 13668-383 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/10/12.5 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/10/12.5 mg | TORRENT PHARMACEUTICALS LIMITED | ANDA | Current |
| 13668-383 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/10/12.5 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/10/12.5 mg | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-383 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/10/12.5 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/10/12.5 mg | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-383 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/10/12.5 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/10/12.5 mg | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-385 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/25 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/5/25 mg | TORRENT PHARMACEUTICALS LIMITED | ANDA | Current |
| 13668-385 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/25 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/5/25 mg | TORRENT PHARMACEUTICALS LIMITED | ANDA | Current |
| 13668-385 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/25 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/5/25 mg | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-385 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/25 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/5/25 mg | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-385 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/25 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/5/25 mg | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-386 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/12.5 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/5/12.5 mg | TORRENT PHARMACEUTICALS LIMITED | ANDA | Current |
| 13668-386 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/12.5 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/5/12.5 mg | TORRENT PHARMACEUTICALS LIMITED | ANDA | Current |
| 13668-386 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/12.5 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/5/12.5 mg | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-386 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/12.5 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/5/12.5 mg | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-386 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/12.5 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/5/12.5 mg | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-397 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 20/5/12.5 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 20/5/12.5 mg | TORRENT PHARMACEUTICALS LIMITED | ANDA | Current |
| 13668-397 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 20/5/12.5 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 20/5/12.5 mg | TORRENT PHARMACEUTICALS LIMITED | ANDA | Current |
| 13668-397 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 20/5/12.5 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 20/5/12.5 mg | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-397 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 20/5/12.5 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 20/5/12.5 mg | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-397 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 20/5/12.5 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 20/5/12.5 mg | Torrent Pharmaceuticals Limited | ANDA | Current |
| 70518-2647 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/25 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/5/25 mg | REMEDYREPACK INC. | ANDA | Current |
| 70518-2647 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/25 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/5/25 mg | REMEDYREPACK INC. | ANDA | Current |
| 70518-2647 | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide 40/5/25 mg | Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablet 40/5/25 mg | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 45698 | ORIG | 2016-10-28 |