اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BENICAR HCT از شرکت DAIICHI SANKYO
New Drug Application (NDA): 021532
Company: DAIICHI SANKYO
| 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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21532_benicar_lbl.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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021532s008ltr.pdf |
|
| 07/13/2005 | SUPPL-4 | Labeling |
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 |
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 | DAIICHI SANKYO |
| 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 PHARMS LTD |
| OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 205391 | AUROBINDO PHARMA 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 | 206515 | TORRENT |
| OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;20MG | TABLET;ORAL | Prescription | No | AB | 208847 | UMEDICA LABS PVT LTD |
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 | DAIICHI SANKYO |
| 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 PHARMS LTD |
| OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 205391 | AUROBINDO PHARMA 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 | 200532 | TEVA PHARMS USA |
| OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 206515 | TORRENT |
| OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 12.5MG;40MG | TABLET;ORAL | Prescription | No | AB | 208847 | UMEDICA LABS PVT LTD |
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 | DAIICHI SANKYO |
| 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 PHARMS LTD |
| OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 25MG;40MG | TABLET;ORAL | Prescription | No | AB | 205391 | AUROBINDO PHARMA 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 | 206515 | TORRENT |
| OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 25MG;40MG | TABLET;ORAL | Prescription | No | AB | 208847 | UMEDICA LABS PVT LTD |
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