Drugs@FDA: FDA-Approved Drugs
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 |
Letter (PDF)
|
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 | 076333 | ANI PHARMS |
BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 076402 | CHARTWELL RX |
BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 077128 | COREPHARMA |
BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 076267 | HERITAGE PHARMA |
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 |
BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 078848 | ZYDUS LIFESCIENCES |
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 | 076333 | ANI PHARMS |
BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 078212 | AUROBINDO PHARMA |
BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 076402 | CHARTWELL RX |
BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 077128 | COREPHARMA |
BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 076267 | HERITAGE PHARMA |
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 |
BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 078848 | ZYDUS LIFESCIENCES |
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 | 076333 | ANI PHARMS |
BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 078212 | AUROBINDO PHARMA |
BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 076402 | CHARTWELL RX |
BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 077128 | COREPHARMA |
BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 076267 | HERITAGE PHARMA |
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 |
BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | No | AB | 078848 | ZYDUS LIFESCIENCES |
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 | 076333 | ANI PHARMS |
BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 078212 | AUROBINDO PHARMA |
BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 076402 | CHARTWELL RX |
BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 077128 | COREPHARMA |
BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 076267 | HERITAGE PHARMA |
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 |
BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | No | AB | 078848 | ZYDUS LIFESCIENCES |
LOTENSIN | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | Yes | AB | 019851 | VALIDUS PHARMS |