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
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE از شرکت SANDOZ
Abbreviated New Drug Application (ANDA): 076631
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET;ORAL | Prescription |
None |
No | No |
| BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET;ORAL | Prescription |
AB |
No | No |
| BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET;ORAL | Prescription |
AB |
No | No |
| BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;25MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/11/2004 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76631ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/03/2020 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/03/2020 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/16/2018 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/24/2016 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/30/2015 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/23/2014 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/23/2014 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/02/2011 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/28/2011 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/17/2010 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/28/2009 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/31/2009 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 09/25/2007 | SUPPL-7 | Labeling |
Label is not available on this site. |
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
TABLET;ORAL; 10MG;12.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 076631 | SANDOZ |
| LOTENSIN HCT | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET;ORAL | Prescription | Yes | AB | 020033 | VALIDUS PHARMS |
TABLET;ORAL; 20MG;12.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 076631 | SANDOZ |
| LOTENSIN HCT | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET;ORAL | Prescription | Yes | AB | 020033 | VALIDUS PHARMS |
TABLET;ORAL; 20MG;25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET;ORAL | Prescription | No | AB | 076631 | SANDOZ |
| LOTENSIN HCT | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET;ORAL | Prescription | Yes | AB | 020033 | VALIDUS PHARMS |
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