Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206137
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
| 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 |
|---|---|---|---|---|---|---|---|
| 10/26/2016 | ORIG-1 | Approval | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206137s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206137Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/02/2023 | SUPPL-6 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/20/2019 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/20/2019 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/26/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206137s000lbl.pdf |
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 | 206137 | ENDO OPERATIONS |
| 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 |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 203580 | TORRENT |
| 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 | 206137 | ENDO OPERATIONS |
| 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 | 206137 | ENDO OPERATIONS |
| 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 | 206137 | ENDO OPERATIONS |
| 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 |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 203580 | TORRENT |
| 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 | 206137 | ENDO OPERATIONS |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;25MG;40MG | TABLET;ORAL | Prescription | No | AB | 202491 | TEVA PHARMS USA |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;25MG;40MG | TABLET;ORAL | Prescription | No | AB | 203580 | TORRENT |
| TRIBENZOR | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;25MG;40MG | TABLET;ORAL | Prescription | Yes | AB | 200175 | COSETTE |