Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 200175
Company: COSETTE
Company: COSETTE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIBENZOR | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;20MG | TABLET;ORAL | Prescription | AB | Yes | No |
| TRIBENZOR | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;12.5MG;40MG | TABLET;ORAL | Prescription | AB | Yes | No |
| TRIBENZOR | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 5MG BASE;25MG;40MG | TABLET;ORAL | Prescription | AB | Yes | No |
| TRIBENZOR | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;12.5MG;40MG | TABLET;ORAL | Prescription | AB | Yes | No |
| TRIBENZOR | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | EQ 10MG BASE;25MG;40MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/23/2010 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200175s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200175s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200175_tribenzor_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200175Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200175s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/200175Orig1s037ltr.pdf | |
| 10/02/2020 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200175s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/200175Orig1s033ltr.pdf | |
| 01/05/2017 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200175s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200175Orig1s026ltr.pdf | |
| 11/01/2016 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200175s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200175Orig1s025ltr.pdf | |
| 09/16/2015 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/23/2014 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200175s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200175Orig1s020ltr.pdf | |
| 06/27/2014 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200175s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200175Orig1s019ltr.pdf | |
| 06/13/2014 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200175s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200175Orig1s018ltr.pdf | |
| 06/20/2014 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/2013 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200175s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200175Orig1s015ltr.pdf | |
| 07/03/2013 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/06/2013 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/10/2012 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200175s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200175Orig1s012ltr.pdf | |
| 09/28/2012 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200175s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200175Orig1s011ltr.pdf | |
| 02/01/2013 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/2012 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200175s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200175s008ltr.pdf | |
| 11/01/2011 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200175s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200175s007ltr.pdf | |
| 06/21/2011 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200175s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200175s003ltr.pdf | |
| 03/25/2011 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200175s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200175s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/02/2020 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200175s033lbl.pdf | |
| 08/20/2020 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/200175s037lbl.pdf | |
| 01/05/2017 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200175s026lbl.pdf | |
| 11/01/2016 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200175s025lbl.pdf | |
| 09/23/2014 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200175s020lbl.pdf | |
| 06/27/2014 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200175s019lbl.pdf | |
| 06/13/2014 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200175s018lbl.pdf | |
| 07/03/2013 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200175s015lbl.pdf | |
| 12/10/2012 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200175s012lbl.pdf | |
| 09/28/2012 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200175s011lbl.pdf | |
| 01/19/2012 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200175s008lbl.pdf | |
| 11/01/2011 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200175s007lbl.pdf | |
| 06/21/2011 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200175s003lbl.pdf | |
| 03/25/2011 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200175s001lbl.pdf | |
| 07/23/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200175s000lbl.pdf |
TRIBENZOR
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 | PAR PHARM INC |
| 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 | PAR PHARM INC |
| 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 | PAR PHARM INC |
| 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 | PAR PHARM INC |
| 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 | PAR PHARM INC |
| 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 |