Application 210718
- Type
- ANDA
- Sponsor
- PIRAMAL
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 |
|---|---|---|---|---|---|---|---|
| A210718-001 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;20MG | TABLET / ORAL | AB | 2025-05-14 | |
| A210718-002 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2025-05-14 | |
| A210718-003 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;25MG;40MG | TABLET / ORAL | AB | 2025-05-14 | |
| A210718-004 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2025-05-14 | |
| A210718-005 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;25MG;40MG | TABLET / ORAL | AB | 2025-05-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210718-001 | AB |
| A210718-002 | AB |
| A210718-003 | AB |
| A210718-004 | AB |
| A210718-005 | 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 | A210718-001 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;20MG | TABLET / ORAL | AB | 2025-05-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A210718-002 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2025-05-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A210718-003 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;25MG;40MG | TABLET / ORAL | AB | 2025-05-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A210718-004 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2025-05-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A210718-005 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;25MG;40MG | TABLET / ORAL | AB | 2025-05-14 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A210718-001 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;20MG | TABLET / ORAL | AB | 2025-05-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210718-002 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2025-05-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210718-003 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;25MG;40MG | TABLET / ORAL | AB | 2025-05-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210718-004 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2025-05-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A210718-005 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;25MG;40MG | TABLET / ORAL | AB | 2025-05-14 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210718-001 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;20MG | TABLET / ORAL | AB | 2025-05-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210718-002 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2025-05-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210718-003 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;25MG;40MG | TABLET / ORAL | AB | 2025-05-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210718-004 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2025-05-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210718-005 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;25MG;40MG | TABLET / ORAL | AB | 2025-05-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210718-001 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;20MG | TABLET / ORAL | AB | 2025-05-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210718-002 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2025-05-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210718-003 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;25MG;40MG | TABLET / ORAL | AB | 2025-05-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210718-004 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2025-05-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210718-005 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;25MG;40MG | TABLET / ORAL | AB | 2025-05-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210718-001 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;20MG | TABLET / ORAL | AB | 2025-05-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210718-002 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2025-05-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210718-003 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;25MG;40MG | TABLET / ORAL | AB | 2025-05-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210718-004 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2025-05-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210718-005 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;25MG;40MG | TABLET / ORAL | AB | 2025-05-14 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210718-001 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;20MG | TABLET / ORAL | AB | 2025-05-14 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210718-002 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2025-05-14 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210718-003 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 5MG BASE;25MG;40MG | TABLET / ORAL | AB | 2025-05-14 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210718-004 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;12.5MG;40MG | TABLET / ORAL | AB | 2025-05-14 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210718-005 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | EQ 10MG BASE;25MG;40MG | TABLET / ORAL | AB | 2025-05-14 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A210718-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A210718-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A210718-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A210718-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A210718-005 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A210718-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210718-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210718-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210718-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A210718-005 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A210718-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210718-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210718-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210718-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210718-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210718-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210718-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210718-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210718-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210718-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210718-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210718-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210718-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210718-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210718-005 | AB | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210718-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210718-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210718-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210718-004 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210718-005 | AB | 1 | a50c72e98297… |
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 amlodipine besylate and hydrochlorothiazide | OLMESARTAN MEDOXOMIL AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE | Slate Run Pharmaceuticals, LLC | a469adff-25a6-4983-b471-60924d920a86 | 2025-06-30 | Boxed warning, Warnings, Adverse reactions | 210718 ANDA210718 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.