Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020033
Company: VALIDUS PHARMS
Company: VALIDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOTENSIN HCT | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| LOTENSIN HCT | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET;ORAL | Prescription | AB | Yes | No |
| LOTENSIN HCT | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| LOTENSIN HCT | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;12.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/19/1992 | ORIG-1 | Approval | Type 4 - New Combination | 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 |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-63 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020033s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020033Orig1s063ltr.pdf | |
| 08/08/2018 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020033s0062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020033Orig1s062ltr.pdf | |
| 08/03/2017 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020033s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020033Orig1s061ltr.pdf | |
| 05/05/2016 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/03/2016 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/12/2016 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/25/2015 | SUPPL-52 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020033s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020033Orig1s052ltr.pdf | |
| 07/07/2015 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/2014 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020033s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020033Orig1s050ltr.pdf | |
| 08/14/2014 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/2014 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/21/2012 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s047lbl.pdf | |
| 07/27/2012 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020033Orig1s046ltr.pdf | |
| 01/19/2012 | SUPPL-45 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019851s043,020033s045ltr.pdf | |
| 02/16/2012 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020033s043ltr.pdf | |
| 06/14/2011 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020033s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020033s041ltr.pdf | |
| 03/17/2011 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020033s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020033s040ltr.pdf | |
| 11/10/2009 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020033s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020033s038ltr.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-33 | 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-25 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19851slr029,20033slr025ltr.pdf |
| 10/25/2002 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/20/2002 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/2002 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/30/2001 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/13/2001 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/14/2001 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 05/10/2000 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/2001 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1999 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/29/1998 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 04/09/1997 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/13/1997 | SUPPL-11 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/02/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/02/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 05/05/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/20/1993 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/30/1993 | 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. |
||
| 11/25/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/07/1993 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/23/1992 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/23/1992 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020033s063lbl.pdf | |
| 08/08/2018 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020033s0062lbl.pdf | |
| 08/03/2017 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020033s061lbl.pdf | |
| 08/25/2015 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020033s052lbl.pdf | |
| 12/12/2014 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020033s050lbl.pdf | |
| 09/21/2012 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s047lbl.pdf | |
| 07/27/2012 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s046lbl.pdf | |
| 02/16/2012 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s043lbl.pdf | |
| 01/19/2012 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020033s045lbl.pdf | |
| 06/14/2011 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020033s041lbl.pdf | |
| 03/17/2011 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020033s040lbl.pdf | |
| 11/10/2009 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020033s038lbl.pdf |
LOTENSIN HCT
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 | 076342 | ANI PHARMS |
| BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 10MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 078794 | APOTEX |
| 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;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 | 076342 | ANI PHARMS |
| BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;25MG | TABLET;ORAL | Prescription | No | AB | 078794 | APOTEX |
| 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 |
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 | 076342 | ANI PHARMS |
| BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | 20MG;12.5MG | TABLET;ORAL | Prescription | No | AB | 078794 | APOTEX |
| 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 |