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 از شرکت PRINSTON INC
Abbreviated New Drug Application (ANDA): 076118
Company: PRINSTON INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription |
AB |
No | No |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription |
AB |
No | No |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription |
AB |
No | No |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 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 |
|---|---|---|---|---|---|---|---|
| 02/11/2004 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76118ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/06/2020 | SUPPL-24 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 11/12/2015 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/12/2015 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/24/2014 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/08/2012 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/26/2010 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/13/2010 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/20/2008 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 08/22/2008 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/25/2007 | SUPPL-9 | Labeling |
Label is not available on this site. |
BENAZEPRIL HYDROCHLORIDE
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 076820 | AMNEAL PHARMS |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 077128 | ANNORA PHARMA |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 078848 | CADILA |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 076402 | CHARTWELL RX |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 076118 | PRINSTON INC |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 076344 | SUN PHARM INDS LTD |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 076211 | TEVA |
| LOTENSIN | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 019851 | VALIDUS PHARMS |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 076820 | AMNEAL PHARMS |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 077128 | ANNORA PHARMA |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 078212 | AUROBINDO PHARMA |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 078848 | CADILA |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 076402 | CHARTWELL RX |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 076118 | PRINSTON INC |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 076344 | SUN PHARM INDS LTD |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 076211 | TEVA |
| LOTENSIN | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | Yes | AB | 019851 | VALIDUS PHARMS |
TABLET;ORAL; 20MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 076820 | AMNEAL PHARMS |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 077128 | ANNORA PHARMA |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 078212 | AUROBINDO PHARMA |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 078848 | CADILA |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 076402 | CHARTWELL RX |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 076118 | PRINSTON INC |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 076344 | SUN PHARM INDS LTD |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 076211 | TEVA |
| LOTENSIN | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | Yes | AB | 019851 | VALIDUS PHARMS |
TABLET;ORAL; 40MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 076820 | AMNEAL PHARMS |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 077128 | ANNORA PHARMA |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 078212 | AUROBINDO PHARMA |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 078848 | CADILA |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 076402 | CHARTWELL RX |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 076118 | PRINSTON INC |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 076344 | SUN PHARM INDS LTD |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 076211 | TEVA |
| LOTENSIN | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | Yes | AB | 019851 | VALIDUS PHARMS |
حتما بخوانید : BENADRYL از شرکت MCNEIL CONS
منبع : www.accessdata.fda.gov
نظرات کاربران