Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019851
Company: VALIDUS PHARMS
Company: VALIDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOTENSIN | BENAZEPRIL HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| LOTENSIN | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | AB | Yes | No |
| LOTENSIN | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET;ORAL | Prescription | AB | Yes | No |
| LOTENSIN | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 06/25/1991 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/07/2019 | SUPPL-54 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019851s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019851Orig1s054ltr.pdf | |
| 08/03/2017 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019851s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019851Orig1s052ltr.pdf | |
| 12/17/2015 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/2015 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019851s045s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019851Orig1s045,s049ltr.pdf | |
| 07/14/2015 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/2015 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019851s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019851Orig1s047ltr.pdf | |
| 12/12/2014 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019851s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019851Orig1s046ltr.pdf | |
| 07/22/2015 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019851s045s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019851Orig1s045,s049ltr.pdf | |
| 09/21/2012 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s044lbl.pdf | |
| 01/19/2012 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019851s043,020033s045ltr.pdf | |
| 05/17/2012 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019851Orig1s042ltr.pdf | |
| 06/14/2011 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019851s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019851s040ltr.pdf | |
| 11/10/2009 | SUPPL-38 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019851s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019851s038ltr.pdf | |
| 01/22/2009 | SUPPL-37 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019851s037,020033s037ltr.pdf |
| 05/29/2008 | SUPPL-36 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019851s036, 020033s036ltr.pdf |
| 02/02/2007 | SUPPL-34 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019851s034, 020033s033ltr.pdf |
| 10/29/2003 | SUPPL-29 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19851slr029,20033slr025ltr.pdf |
| 03/02/2004 | SUPPL-28 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/019851s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19851se5-028ltr.pdf | |
| 10/25/2002 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/20/2002 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/2002 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/2001 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/13/2001 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/14/2001 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 11/02/2000 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/2000 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1999 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/20/1998 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/29/1998 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 08/13/1997 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/18/1997 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/13/1997 | SUPPL-13 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/25/1996 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/02/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/07/1995 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/22/1995 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 02/08/1995 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1995 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/15/1994 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/21/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 11/20/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/25/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/13/1992 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/09/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/07/2019 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019851s054lbl.pdf | |
| 08/03/2017 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019851s052lbl.pdf | |
| 07/22/2015 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019851s045s049lbl.pdf | |
| 07/22/2015 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019851s045s049lbl.pdf | |
| 01/26/2015 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019851s047lbl.pdf | |
| 12/12/2014 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019851s046lbl.pdf | |
| 09/21/2012 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s044lbl.pdf | |
| 05/17/2012 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s042lbl.pdf | |
| 01/19/2012 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019851s043lbl.pdf | |
| 06/14/2011 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019851s040lbl.pdf | |
| 11/10/2009 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019851s038lbl.pdf | |
| 03/02/2004 | SUPPL-28 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/019851s028lbl.pdf |
LOTENSIN
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 |