Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202491
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;20MG | TABLET;ORAL | Prescription | AB | No | No |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;40MG | TABLET;ORAL | Prescription | AB | No | No |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;25MG;40MG | TABLET;ORAL | Prescription | AB | No | No |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;12.5MG;40MG | TABLET;ORAL | Prescription | AB | No | No |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;25MG;40MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/03/2016 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/01/2023 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/10/2019 | SUPPL-1 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
TABLET;ORAL; EQ 5MG BASE;12.5MG;20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 209242 | HETERO LABS LTD V |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 207088 | MACLEODS PHARMS LTD |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 207437 | MICRO LABS |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 206137 | PH HEALTH |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 210718 | PIRAMAL |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 202491 | TEVA PHARMS USA |
| TRIBENZOR | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;20MG | TABLET;ORAL | Prescription | Yes | AB | 200175 | COSETTE |
TABLET;ORAL; EQ 5MG BASE;12.5MG;40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 209242 | HETERO LABS LTD V |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 207088 | MACLEODS PHARMS LTD |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 207437 | MICRO LABS |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 206137 | PH HEALTH |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 210718 | PIRAMAL |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 202491 | TEVA PHARMS USA |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 203580 | TORRENT |
| TRIBENZOR | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;40MG | TABLET;ORAL | Prescription | Yes | AB | 200175 | COSETTE |
TABLET;ORAL; EQ 5MG BASE;25MG;40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;25MG;40MG | TABLET;ORAL | Prescription | No | AB | 209242 | HETERO LABS LTD V |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;25MG;40MG | TABLET;ORAL | Prescription | No | AB | 207088 | MACLEODS PHARMS LTD |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;25MG;40MG | TABLET;ORAL | Prescription | No | AB | 207437 | MICRO LABS |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;25MG;40MG | TABLET;ORAL | Prescription | No | AB | 206137 | PH HEALTH |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;25MG;40MG | TABLET;ORAL | Prescription | No | AB | 210718 | PIRAMAL |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;25MG;40MG | TABLET;ORAL | Prescription | No | AB | 202491 | TEVA PHARMS USA |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;25MG;40MG | TABLET;ORAL | Prescription | No | AB | 203580 | TORRENT |
| TRIBENZOR | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;25MG;40MG | TABLET;ORAL | Prescription | Yes | AB | 200175 | COSETTE |
TABLET;ORAL; EQ 10MG BASE;12.5MG;40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 209242 | HETERO LABS LTD V |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 207088 | MACLEODS PHARMS LTD |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 207437 | MICRO LABS |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 206137 | PH HEALTH |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 210718 | PIRAMAL |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 202491 | TEVA PHARMS USA |
| TRIBENZOR | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;12.5MG;40MG | TABLET;ORAL | Prescription | Yes | AB | 200175 | COSETTE |
TABLET;ORAL; EQ 10MG BASE;25MG;40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;25MG;40MG | TABLET;ORAL | Prescription | No | AB | 209242 | HETERO LABS LTD V |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;25MG;40MG | TABLET;ORAL | Prescription | No | AB | 207088 | MACLEODS PHARMS LTD |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;25MG;40MG | TABLET;ORAL | Prescription | No | AB | 207437 | MICRO LABS |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;25MG;40MG | TABLET;ORAL | Prescription | No | AB | 206137 | PH HEALTH |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;25MG;40MG | TABLET;ORAL | Prescription | No | AB | 210718 | PIRAMAL |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;25MG;40MG | TABLET;ORAL | Prescription | No | AB | 202491 | TEVA PHARMS USA |
| TRIBENZOR | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;25MG;40MG | TABLET;ORAL | Prescription | Yes | AB | 200175 | COSETTE |