Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021532
Company: COSETTE
Company: COSETTE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BENICAR HCT | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET;ORAL | Prescription | AB | Yes | No |
BENICAR HCT | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET;ORAL | Prescription | AB | Yes | No |
BENICAR HCT | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 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 |
---|---|---|---|---|---|---|---|
06/05/2003 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21532_benicar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21532ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021532_benicar_toc.cfm |
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/2020/021532s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021532Orig1s037ltr.pdf | |
05/13/2016 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/23/2014 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021532s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021532Orig1s026ltr.pdf | |
06/27/2014 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021532s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021532Orig1s025ltr.pdf | |
06/13/2014 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021532s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021532Orig1s024ltr.pdf | |
05/07/2014 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/03/2013 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021532s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021532Orig1s022ltr.pdf | |
12/11/2012 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021532s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021532Orig1s021ltr_r.pdf | |
09/18/2012 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021532s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021532Orig1s020ltr.pdf | |
02/01/2013 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/18/2012 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021532s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021532s016ltr.pdf | |
02/11/2016 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021532s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021532Orig1s015ltr.pdf | |
05/03/2011 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021532s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021532s013,s014ltr.pdf | |
05/03/2011 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021532s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021532s013,s014ltr.pdf | |
11/16/2007 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021532s008ltr.pdf |
07/13/2005 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021532s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021532s004ltr.pdf | |
11/12/2004 | SUPPL-1 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21532s001ltr.pdf |
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) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021532s037lbl.pdf | |
02/11/2016 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021532s015lbl.pdf | |
09/23/2014 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021532s026lbl.pdf | |
06/27/2014 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021532s025lbl.pdf | |
06/13/2014 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021532s024lbl.pdf | |
07/03/2013 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021532s022lbl.pdf | |
12/11/2012 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021532s021lbl.pdf | |
09/18/2012 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021532s020lbl.pdf | |
01/18/2012 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021532s016lbl.pdf | |
05/03/2011 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021532s013s014lbl.pdf | |
05/03/2011 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021532s013s014lbl.pdf | |
07/13/2005 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021532s004lbl.pdf | |
06/05/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21532_benicar_lbl.pdf |
BENICAR HCT
TABLET;ORAL; 12.5MG;20MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BENICAR HCT | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET;ORAL | Prescription | Yes | AB | 021532 | COSETTE |
HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 207037 | ALKEM LABS LTD |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 209281 | ACCORD HLTHCARE |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 204233 | ALEMBIC |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 205391 | AUROBINDO PHARMA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 204801 | MACLEODS PHARMS LTD |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 207804 | PRINSTON INC |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 208847 | UMEDICA |
TABLET;ORAL; 12.5MG;40MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BENICAR HCT | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET;ORAL | Prescription | Yes | AB | 021532 | COSETTE |
HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 207037 | ALKEM LABS LTD |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 209281 | ACCORD HLTHCARE |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 204233 | ALEMBIC |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 205391 | AUROBINDO PHARMA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 204801 | MACLEODS PHARMS LTD |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 207804 | PRINSTON INC |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 208847 | UMEDICA |
TABLET;ORAL; 25MG;40MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BENICAR HCT | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 25MG;40MG | TABLET;ORAL | Prescription | Yes | AB | 021532 | COSETTE |
HYDROCHLOROTHIAZIDE AND OLMESARTAN MEDOXOMIL | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 25MG;40MG | TABLET;ORAL | Prescription | No | AB | 207037 | ALKEM LABS LTD |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 25MG;40MG | TABLET;ORAL | Prescription | No | AB | 209281 | ACCORD HLTHCARE |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 25MG;40MG | TABLET;ORAL | Prescription | No | AB | 204233 | ALEMBIC |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 25MG;40MG | TABLET;ORAL | Prescription | No | AB | 205391 | AUROBINDO PHARMA |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 25MG;40MG | TABLET;ORAL | Prescription | No | AB | 204801 | MACLEODS PHARMS LTD |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 25MG;40MG | TABLET;ORAL | Prescription | No | AB | 207804 | PRINSTON INC |
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 25MG;40MG | TABLET;ORAL | Prescription | No | AB | 208847 | UMEDICA |